CinFina Pharma Announces FDA Clearance of Investigational New Drug Application and First Participants Dosed in Phase 1 Trial of CIN-110 for the Treatment of Obesity

CIN-110 is a potent and highly selective large molecule peptide YY (PYY3-36) with an extended half-life being developed as a monotherapy and co-administration agent to induce satiety, reduce appetite and impact glucose metabolism

CIN-110 is the second therapeutic in CinFina’s metabolic portfolio to reach the in-human clinical trial milestone

CINCINNATI – March 26, 2024 – CinFina Pharma, a CinRx portfolio company dedicated to advancing a portfolio of high-impact treatment options for obesity and metabolic diseases, announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug Application (IND) for CIN-110, a PYY3-36 analog, allowing the first in-human clinical study to proceed. With the commencement of the trial, CinFina also announced the first cohort of participants has been dosed. The trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CIN-110 in a randomized, double-blind, placebo-controlled, single ascending dose study in otherwise healthy subjects with obesity.

“Despite the emergence of new medicines to help address the obesity epidemic, there remains an unmet medical need for therapeutics that are well tolerated for long-term treatment,” said Dr. Jon Isaacsohn, Founder and Chief Executive Officer at CinRx Pharma. “As demonstrated by promising preclinical efficacy data, CIN-110 has the potential to meet these needs and provide important therapeutic advantages to patients in monotherapy and combination settings, including durability of weight loss. We look forward to continuing to explore its safety and tolerability profiles in this important Phase 1 study.”

CIN-110 is a stable and long-acting analog of  PYY3-36 being developed both as a monotherapy and co-administration agent for obesity. PYY3-36 is an endogenous hormone secreted in the gut, which activates the neuropeptide Y2 receptor (Y2R) to reduce appetite and food intake. Unlike prior attempts at developing a PYY focused therapeutic, CIN-110 is uniquely designed to limit severe nausea and emesis and still deliver on the promise of effective, long-term weight loss. CIN-110 selectively binds and activates Y2R, the target for native PYY3-36. Pharmacodynamic evaluation of CIN-110 demonstrated that repeat subcutaneous dosing leads to significant reduction of food intake and body weight in obese, non-human primates and rodents. Additionally, data shows CIN-110 led to an improvement of glucose homeostasis and insulin sensitivity in animal models. The toxicology program results indicated that CIN-110 was well tolerated with no adverse findings noted in either non-human primates or rodents. The results from the preclinical efficacy and safety studies support the progression of CIN-110 to human clinical trials.

 

“The preclinical program of CIN-110 underscores the potential for PYY to be a differentiated approach to treat obesity. This uniquely engineered molecule holds promise to expand the current therapeutic paradigm beyond GLP-1s with its selectivity, potency and half-life extension,” said Brian Murphy, M.D., Chief Medical Officer at CinRx Pharma... CinFina Pharma's Press Release -

Tetra Pharm Technologies advances CB1 antagonist, TPT0701, for appetite suppression into preclinical testing

The Danish biopharmaceutical company, Tetra Pharm Technologies, proudly announces a significant milestone in the realm of appetite suppression research having developed a cutting-edge compound leveraging their innovative platform technology.

COPENHAGEN, Denmark, Feb. 8, 2024 -- Following the successful filing of Intellectual Property (IP) for their applied platform technology targeting the endocannabinoid system (ECS), Tetra Pharm Technologies, is moving forward with its compound for appetite suppression, TPT0701.

Endocannabinoid system modulation has long been recognized as a promising avenue for appetite regulation. Through rigorous research and development efforts, Tetra Pharm Technologies has unlocked the potential of this biological system to address one of the most pressing health challenges of our time – excessive appetite and weight gain.

TPT0701 was originally designed in 2022 for obese patients suffering from schizophrenia but will now move into the development stage as appetite suppressing medication for general weight loss.

Dr. Morten Allesø, Chief Scientific Officer, Tetra Pharm Technologies, said: "With our new, proprietary platform technology as our secret weapon to unlock the endless possibilities of the endocannabinoid system, we are now ready to finalize TPT0701 for pre-clinical testing in 2024".

"Compounds, such as TPT0701, display physicochemical properties that render them difficult to formulate by means of conventional approaches. Our enabling platform technology, now with an IP application supporting it, can accommodate exactly these types of molecules and will help overcome otherwise hampering drug delivery challenges such as poor absorption and ultimately low bioavailability. Indeed, a drug is only as good as its delivery system, and with a check mark secured on both the formulation technology and the pharmacological mode of action established in early drug discovery, we are confident in the ongoing success of TPT0701 as it progresses through development," added Morten Allesø.

TPT0701 offers a novel approach to appetite suppression, aiming to provide individuals with a safe and effective means to manage their cravings and achieve their wellness goals. By specifically targeting the endocannabinoid system, Tetra Pharm Technologies' solution holds promise for combating obesity and related metabolic disorders, with far-reaching implications for public health.

"Obesity and its associated health risks have reached alarming levels worldwide, necessitating innovative approaches to address this pressing issue. Research and development are our top priority, and we will continue to invest in building our pipeline of new drug candidates targeting the endocannabinoid system and related disease indications", says Martin Rose, Chief Executive Officer, Tetra Pharm Technologies... Tetra Pharm Technologies' Press Release -

Scholar Rock Announces FDA Clearance of IND Application to Initiate Phase 2 Proof-of-Concept Trial with Apitegromab to Treat Obesity

• Randomized Phase 2 proof-of-concept trial with apitegromab in patients with obesity on GLP-1 therapies on track to initiate mid-2024
• Study aims to show the importance of selective myostatin inhibition in preservation of lean muscle mass as part of healthy, safe weight loss management
• Scholar Rock is also developing SRK-439, a novel investigational selective myostatin inhibitor, optimized for the treatment of obesity

CAMBRIDGE, Mass.--Jan. 23, 2024-- Scholar Rock (NASDAQ: SRRK) (the Company), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its Phase 2 proof-of-concept trial of apitegromab to treat obesity in patients taking a GLP-1 receptor agonist (GLP-1 RA).

The Phase 2 trial is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the effect of apitegromab, a highly selective myostatin inhibitor, to safely preserve lean muscle mass as an adjunctive therapy in overweight and obese adults who are taking a GLP-1 RA. Trial initiation is on track for mid-2024, and data from the apitegromab Phase 2 trial are expected in mid-2025. In parallel, Scholar Rock is developing SRK-439, a novel investigational selective myostatin inhibitor, optimized for the treatment of obesity. The Company plans to file an IND for SRK-439 in 2025.

“The FDA’s acceptance of our IND application to study apitegromab in obesity allows us to assess the effect of our highly selective myostatin inhibitor on preserving lean muscle mass, and safety and tolerability of our approach when combined with a GLP-1 RA. The IND builds on our encouraging apitegromab clinical and safety data to date and allows us to inform the development of our cardiometabolic program with SRK-439, a novel preclinical selective myostatin inhibitor optimized for development in cardiometabolic disorders,” said Jay Backstrom, M.D., MPH, President and Chief Executive Officer of Scholar Rock. “Maintaining lean mass during weight loss is important to overall metabolic health, and we look forward to initiating the Phase 2 proof-of-concept trial in apitegromab to validate our differentiated approach of selectively targeting only the pro- and latent forms of myostatin to retain muscle mass.”... Scholar Rock's Press Release -

Rhythm Pharmaceuticals Announces Completion of Screening for Enrollment in Setmelanotide Phase 3 Hypothalamic Obesity Trial and Additional Updates

-- Phase 3 hypothalamic obesity top-line data expected in 1H2025 --

-- Positive reimbursement decision achieved for IMCIVREE® (setmelanotide) to treat patients with Bardet-Biedl syndrome and POMC/LEPR deficiencies in Spain --

-- IND application for RM-718 accepted by the FDA --

BOSTON, Jan. 04, 2024 -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, provided a business update and announced it has completed screening for enrollment in the pivotal, Phase 3 clinical trial evaluating setmelanotide in patients with acquired hypothalamic obesity.

Rhythm closed screening and anticipates overenrolling the ongoing phase 3 hypothalamic obesity trial with more than 140 patients consented and going through active screening and baseline assessments. In this trial, patients with acquired hypothalamic obesity aged 4 years or older will be randomized 2:1 to setmelanotide therapy or placebo for a total of 60 weeks, including up to eight weeks for dose titration. The Company expects to obtain top-line study results in H1 2025.

“2023 was a truly transformational year for Rhythm, as we made excellent progress with the execution of our IMCIVREE® (setmelanotide) commercial plan while also advancing important development efforts to expand the number of patients living with hyperphagia and severe obesity that could potentially benefit from this therapy,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “We believe the rapid over enrollment in less than one year and execution of our Phase 3 hypothalamic obesity trial is a strong indicator of the unmet need for an effective therapy for patients who have no approved therapeutic options and the community’s excitement around setmelanotide’s potential to make a meaningful difference in their lives.”... Rhythm Pharmaceuticals' Press Release -

Keros Therapeutics to Develop KER-065 for the Treatment of Obesity

Keros commenced a randomized, double-blind, placebo-controlled, two-part Phase 1 clinical trial to evaluate single and multiple ascending doses of KER-065 in healthy volunteers

Keros expects to report initial data from this Phase 1 clinical trial in the first quarter of 2025

Preclinical data showed potential proof-of-mechanism of KER-065 for the treatment of obesity

Keros believes these preclinical data support developing KER-065 for the treatment of obesity, and Keros plans to initiate a proof-of-concept trial of KER-065 in obese patients following completion of this Phase 1 clinical trial

LEXINGTON, Mass., Jan. 03, 2024 - Keros Therapeutics, Inc. (“Keros” or “we”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, announced that it plans to develop KER-065, a novel ligand trap designed to bind to and inhibit TGF-ß ligands, including myostatin (GDF8) and activin A, for the treatment of obesity.

“Obesity is a complex and chronic disease associated with numerous comorbidities and a growing prevalence in patients. We believe there is a need for additional treatment options, including one that leads to weight loss without an associated loss of muscle and a potential for frailty. Based on our preclinical data, we believe that KER-065 has the potential to treat obesity without those limitations, by increasing skeletal muscle, reducing fat mass through an increase in energy expenditure, improving insulin sensitivity and improving cardiac function,” said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. “To that end, we recently commenced our Phase 1 clinical trial evaluating KER-065 in healthy volunteers and, following its successful completion, plan to initiate a proof-of-concept trial of KER-065 in obese patients.”... Keros Therapeutics' Press Release - 

Resalis Therapeutics Raises €10 Million Series A to Complete First Clinical Trial for RES-010 in Obesity

January 04, 2024- TORINO, Italy- Resalis Therapeutics announced the closing of a €10 million ($11 million) Series A financing round led by Sunstone Life Science Ventures with participation from existing investors including Claris Ventures and angel investors. The proceeds will be used to initiate and complete the first-in-human Phase 1 clinical trial and reach Phase 2 readiness for Resalis’ lead program, RES-010, in obesity. RES-010 is a non-coding RNA-based compound designed to provide a disease-modifying approach in obesity with longer-lasting weight reduction and the ability to extend treatment durability in combination with approved therapeutics, such as GLP-1 receptor agonists. In conjunction with the financing, Claus Andersson, PhD, General Partner of Sunstone Life Science Ventures, will join Resalis’ Board of Directors.

“The successful close of our Series A is an important milestone for Resalis because it will enable us to reach the clinic and to achieve the next significant inflection point with our lead candidate, RES-010. With RES-010 we aim to provide a therapeutic that precisely reduces fat mass in obesity with the potential to extend the durability of existing therapies. We value the trust and support of our new and current investors, and eagerly look forward to this next phase of development,” said Alessandro Toniolo, CEO of Resalis Therapeutics.

“Resalis’ therapeutic approach is based on groundbreaking science that has rapidly led to the development of a lead candidate, now on the cusp of clinical evaluation. Preserving muscle mass is key to provide a sustained and meaningful clinical benefit, and we share the team’s vision that this non-GLP1/GIP therapeutic will significantly improve both effect and tolerability of today’s therapies. This investment underscores our belief in the company’s vision and the transformative potential of its lead candidate to make a meaningful impact for obese patients,” said Claus Andersson, General Partner at Sunstone Life Science Ventures.

Pietro Puglisi, Managing Partner at Claris Ventures and Chairman of the Board at Resalis Therapeutics, added: “In recent years, there has been remarkable progress in the treatment of metabolic disorders. Yet, there persists a critical need for innovative solutions that can both provide orthogonal therapeutic effects and pave the way for combination therapies. I look forward to the continued collaboration with the outstanding Resalis team and welcoming Claus as a new member of the Resalis Board.”

Resalis has a deep understanding of the field of ncRNAs and RNA-targeted therapeutics in human health and metabolic disorders. The company’s lead candidate, RES-010, is an antisense oligonucleotide that targets miR-22, a central player in the regulation of lipid metabolism and energy consumption. In multiple proof-of-concept studies in large and small animal models, RES-010 has shown the potential to provide a safe and longer-lasting therapeutic effect, alone or in combination with approved drugs. Resalis plans to initiate a Phase 1 clinical study evaluating the safety and efficacy of RES-010 in the first half of 2024. RES-010 is patent-protected in the US, Japan and China with patents pending in the EU... Resalis Therapeutics' Press Release [PDF] - 

Lilly's Zepbound (tirzepatide) achieved additional 6.7% weight loss following a 36-week open-label lead-in period, for a total mean weight loss of 26.0% from study entry over 88 weeks

 People who were randomized to placebo following the lead-in period experienced mean weight regain of 14.8% at 88 weeks, indicating Zepbound led to sustained weight loss compared to placebo

Full results from the SURMOUNT-4 study were published in The Journal of the American Medical Association

INDIANAPOLIS, Dec. 11, 2023 -- Detailed results from SURMOUNT-4, which showed Zepbound™ (tirzepatide) injection achieved superior mean percent change in body weight compared to placebo in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes, were published in The Journal of the American Medical Association (JAMA). Zepbound met the primary endpoint of mean percent change in body weight, and all key secondary endpoints for both estimandsi,ii, compared to placebo 52 weeks after randomization.

Study Design

SURMOUNT-4, a phase 3 study evaluating the safety and efficacy of Zepbound compared to placebo, had two periods.

Lead-in period: 36-week open-label period during which participants took Zepbound at the maximum tolerated dose.

Double-blind treatment period: 52-week treatment period during which participants were randomized to either continue on Zepbound or switch to placebo.

SURMOUNT-4 utilized a maximum tolerated dose of 10 mg or 15 mg once-weekly. The starting dose of 2.5 mg Zepbound was increased by 2.5 mg every four weeks until maximum tolerated dose was achieved. Participants who tolerated 15 mg continued on 15 mg as their maximum tolerated dose. Participants who tolerated 10 mg but did not tolerate 15 mg continued on 10 mg as their maximum tolerated dose.

"Patients, providers and the public do not always understand obesity is a chronic disease that often requires ongoing treatment, which can mean that treatment is stopped once weight goals are met," said Jeff Emmick, MD, Ph.D., senior vice president, product development, Lilly. "However, studies like SURMOUNT-4 show that continued therapy can help people living with obesity maintain their weight loss."... Lilly's Press Release - Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity - The SURMOUNT-4 Randomized Clinical Trial in The Journal of the American Medical Association (JAMA) - A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss (SURMOUNT-4) - 

OrsoBio Announces $60M Series A Financing to Advance Metabolic Portfolio for the Treatment of Obesity and Associated Disorders

OrsoBio Announces $60M Series A Financing to Advance Metabolic Portfolio for the Treatment of Obesity and Associated Disorders

Co-led by Longitude Capital and Enavate Sciences, with Significant Participation by Existing Investors Samsara BioCapital and NuevaBio

MENLO PARK, Calif. – November 7, 2023 – OrsoBio, Inc. (“OrsoBio” or “the Company”), a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced the successful completion of a $60 million Series A financing, bringing the total capital raised by the Company to $97 million.

[...]

OrsoBio will utilize the Series A funding to advance the development of its innovative portfolio of four programs focused on obesity and associated metabolic disorders.

Mitochondrial protonophore portfolio: Clinical development of the liver-targeted protonophore TLC-6740 through a Phase 1b study to establish proof of concept and initiation of a Phase 2a study in patients living with obesity, and advancement of IND-enabling activities for TLC-1235, a controlled-release mitochondrial protonophore.

• TLC-3595 (ACC2 inhibitor): Completion of a Phase 2a study in patients with insulin resistance/diabetes (NCT05665751) and preparations for a Phase 2b study.
• TLC-2716 (LXR inverse agonist): Completion of a Phase 2a study in patients with severe hypertriglyceridemia (SHTG)/nonalcoholic steatohepatitis (NASH) and groundwork for a Phase 2b program.
• ACMSD inhibitor (aminocarboxymuconate semialdehyde decarboxylase inhibitor): Selection of a development candidate for potential treatment of metabolic and inflammatory liver and kidney disorders and advancement of IND-enabling activities...OrsoBio's Press Release.

PROLOR Biotech : Positive Results of Its Obesity/Diabetes Drug Candidate in Preclinical Weight Loss Study

April 17, 2012 - PROLOR Biotech, Inc. (NYSE Amex: PBTH) reported positive preclinical results from an animal study of its long-acting obesity/Type II diabetes drug candidate MOD-6030. The study was designed to measure the potential therapeutic effect of MOD-6030 injected once weekly as measured by weight loss, reduction in food intake, glycemic control and cholesterol levels. The study results will be presented at GTC's 5th Diabetes Drug Discovery and Development Conference on April 19, 2012 in Boston, MA.

In the study, MOD-6030 administered to diet-induced obese (DIO) mice once weekly over a 30-day period demonstrated significant efficacy in reducing weight, lowering blood glucose levels, increasing insulin sensitivity and reducing cholesterol levels as compared to a group that received placebo. Animals in the placebo group showed minimal changes in the study parameters, while the animals receiving MOD-6030 achieved on average a 28% reduction in weight, a 29% reduction in food intake, a 19% reduction in blood glucose levels and a 57% reduction in cholesterol levels. Body composition analysis showed that the weight loss resulted specifically from reductions in body fat... [PDF] PROLOR Biotech's Press Release -

LATITUDE Pharmaceuticals : Stable Liquid Glucagon Formulation

April 03, 2012 - LATITUDE Pharmaceuticals, Inc. (LPI) announced that its scientists have developed the first ever, ready-to-inject, stable liquid glucagon formulation (Nano-G). A glucagon formulation with these properties had been a highly sought after Holy Grail of drug developers for decades.

Currently, glucagon is indicated for emergency treatment of insulin-induced hypoglycemia and as a diagnostic aid for radiological examinations. Researchers have long been interested in evaluating glucagon for hypoglycemia prevention, the bi-hormonal insulin/glucagon pump and the treatment of obesity but have been thwarted by the absence of a stable injectable glucagon formulation.

Glucagon is a notoriously insoluble and unstable molecule and is therefore provided as a dried powder. Before use, the glucagon is dissolved in an acid solution by following a cumbersome, eight-step procedure that becomes an outsized task during life-threatening hypoglycemia.

Nano-G is a pH-neutral, isotonic, detergent-free, aqueous formulation that contains only FDA-approved injectable ingredients. Results from rigorous 6-month real-time and accelerated ICH stability testing predict a 2-yr shelf-life. Nano-G is also stable at body temperature, making it highly suitable for subcutaneous infusion pump delivery.

“Nano-G fulfills the long overdue need for a rapidly self-administered, auto-injector delivered glucagon for hypoglycemia rescue and is the missing piece needed for the bi-hormonal pump and novel combination therapies for obesity... LATITUDE Pharmaceuticals' Press Release -

AMA : Free ‘Weigh What Matters’ App to Help People Achieve Healthier Lifestyles

Jan. 30, 2012 – Many Americans resolved to become healthier in the new year, but are having trouble monitoring their progress to achieve their goals. Now there's an app for that. The American Medical Association (AMA) released a free app today to help patients improve their overall health as part of the AMA Healthier Life Steps program, which promotes healthy choices and healthy lives.

"Every January, Americans implement New Year's resolutions that involve healthy eating and increased physical activity," said AMA President Peter W. Carmel, M.D. "This new app encourages people to work with their physicians to set healthy goals, and it allows users to track their progress and accomplish their goals."

The Weigh What Matters app is free, easy to use and encourages users to consult with their physician to establish personal health goals for three categories: weight, eating and activity. Once goals are established, users can track their weight, physical activity and nutrition with daily entries. It also calculates a user's Body Mass Index (BMI) and provides a mechanism to view progress reports and email them to the user's physician.

"The AMA Healthier Life Steps program offers tools and information to help physicians and patients work together to promote longer, healthier lives," said Dr. Carmel. "Physicians and their staff can use this new app as a resource to work with patients to address challenging behavioral changes."...American Medical Association's Press Release -

Oragenics : Positive Clinical Results for its Proprietary Weight Loss Agent, LPT3-04

February 14, 2012 - Oragenics, Inc. (OTCBB:ORNI) announced that a recently completed randomized, double-blind, placebo-controlled, human clinical study with 32 enrolled subjects resulted in a statistically and clinically significant reduction in body weight when healthy, overweight and mildly obese adult volunteers were given daily supplementation of Oragenics’ Weight Loss Agent LPT3-04 over a twelve-week period. This study, sponsored by Oragenics, was conducted at the Miami Research Associates (MRA) clinical research facilities in Miami, Florida. MRA investigators also confirmed that there were no safety concerns with daily supplementation of LPT3-04 over the 12-week duration of the trial, and that no reports of serious adverse events, including depression, occurred during this trial. This human study result confirms the extensive results obtained from animal safety and efficacy studies completed to date by Oragenics, and suggests that LPT3-04, a natural occurring dietary substance with an excellent safety and tolerance profile, can support weight loss in overweight men and women.

The World Health Organization estimated that by 2015, there will be more than 1.5 billion overweight consumers. Further, according to a 2012 healthcare market research report published by Markets and Markets, the total global weight loss market is expected to be worth US$586.3 billion by 2014, with a compound annual growth rate of 10.9% from 2009 to 2014. These reports suggest that the opportunities for a scientifically-substantiated weight management product are impressive...[PDF] Oragenics' Press Release -

Hanmi : license agreement for a new anti-obesity botanical drug

16, Feb. 2012 - Hanmi pharmaceuticals announced that it has entered into a licensing agreement with AngioLab for a new anti-obesity botanical drug, ALS-L1023.

ALS-L1023 is a Melissa leaf (Lemon Balm) ethyl acetate dried extract, having excellent angiogenesis and MMP inhibitory activities. The inhibition of angiogenesis in the growing adipose tissue is a novel approach for the prevention and treatment of obesity having a high specificity to visceral fat (intra-abdominal fat).

A randomized, double-blind, placebo-controlled, phase II human trial was completed in ASAN Medical Center and Inje University Seoul Paik Hospital. The statistically significant reduction of visceral fat by 15% was observed in comparison with the baseline after 12 weeks. In safety assessment, there was no statistically significant Adverse Events. Furthermore, plasma adiponectin level has increased, while plasma free fatty acid level has decreased... Hanmi pharmaceuticals' Press Release -

Bridge Bioresearch : Completion of Preclinical Trials of 2hydroxyoleic Acid - a Novel Treatment of Obesity

LONDON, January 11, 2012 - Bridge Bioresearch PLC (BBR) announces that the company has completed the preclinical efficacy and safety trials of 2hydroxyoleic acid (2OHOA) a novel treatment of obesity and other metabolic disorders.

BBR has in- licensed 2OHOA from the University of the Balearic Islands (Spain) in 2006 and has continued research in animal models verifying the pharmacological properties as well as safety profile of the 2OHOA molecule. This is an important milestone for the further development of 2HOA and the move from pre-clinical to clinical development of the molecule as all the tests completed to-date have shown the molecule to be biologically active and safe in the standard animal models.

Søren Stenderup, CEO of BBR commented: "The successful completion of the pre-clinical programme is a significant milestone for this molecule. The fact that the product shows good biological activity and no observed toxicity gives us the confidence to commit time and resource to undertaking a full clinical development programme. The observation, in the animal models examined, that the product appears to improve other conditions associated with obesity such as hypertension and the onset of type 2 diabetes is an additional benefit that we will seek to quantify in the clinical trial programme as this will give the product benefits over other treatments for the growing problem of obesity."

About the 2hydroxyoleic acid molecule: 

2OHOA has a granted patent (PCT/ES02/00475) and the clinical development process as drug for the treatment of obesity has already been initiated following the encouraging results from the pre-clinical studies... Bridge Bioresearch's Press Release -

Arena Pharmaceuticals and Eisai : FDA Accepts Resubmission of Lorcaserin New Drug Application

Jan. 10, 2012 - Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced that the US Food and Drug Administration (FDA) has accepted for filing and review Arena's resubmission of the New Drug Application (NDA) for lorcaserin. The FDA considers the resubmission a complete, class 2 response, and assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012.

Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, > 30) or patients who are overweight (BMI > 27) and have at least one weight-related co-morbid condition. Arena submitted the original NDA for lorcaserin in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. Arena submitted a response to the lorcaserin CRL in December 2011.

About Lorcaserin

Lorcaserin is an investigational new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain... Arena Pharmaceuticals' Press Release - [PDF] Eisai's Press Release -

Ember Therapeutics : Nature Publication of Brown Fat Biology Data

January 11, 2012 - Program Exclusively Licensed from the Dana-Farber Cancer Institute -


Novel Hormone Identified that Augments Brown Fat, Increases Energy Expenditure, and Reduces Obesity and Insulin Resistance -

Ember Therapeutics, Inc., a company harnessing breakthroughs in brown fat biology and insulin sensitization to revolutionize the treatment of metabolic disease, announced the publication of key data supporting its lead brown fat biology program in the journal Nature. The paper details for the first time the discovery and identification of a new hormone, irisin, which is present and identical in mice and humans and has been shown to act on white fat cells in culture and in vivo to stimulate UCP1 expression and brown fat development. The publication outlines how even relatively short treatments of obese mice with irisin caused an increase in energy expenditure with no changes in activity levels or food intake, resulting in improved glucose homeostasis and weight loss.

This research was led by Bruce Spiegelman, Ph.D., professor of cell biology, Dana-Farber Cancer Institute, Harvard Medical School, and a co-founder of Ember, and was funded by the National Institutes of Health. Ember recently entered into an exclusive license agreement with Dana-Farber Cancer Institute for this irisin technology and is optimizing and developing a proprietary molecule designed to augment and activate the body’s brown fat... [PDF] Ember Therapeutics' Press Release -

Isis : Phase 1 Clinical Trial of ISIS-FGFR4Rx a Peripherally Acting Drug to Treat Obesity

Calif., Dec. 20, 2011 - Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 1 study of ISIS-FGFR4Rx, an antisense drug designed to treat obesity. ISIS-FGFR4Rx specifically reduces the production of fibroblast growth factor receptor 4 (FGFR4) in the liver and fat tissues, which decreases the body's ability to store fat while simultaneously increasing fat burning and energy expenditure. Because ISIS-FGFR4Rx does not distribute to the brain or central nervous system (CNS), ISIS-FGFR4Rx should not produce any CNS side effects. Many anti-obesity drugs primarily work to suppress appetite by acting in the brain, commonly resulting in CNS side effects.

"Obesity is an epidemic in the United States and much of the rest of the industrialized world. Obesity is a serious condition that increases the risk of diabetes, heart disease, stroke, arthritis and some cancers. Severely obese patients make up the most rapidly growing part of the obese population. In these severely obese patients, bariatric, or weight-loss, surgery is a preferred therapeutic option; however long-term weight loss remains a challenge for these patients," said Richard Geary, Ph.D., Senior Vice President of Development at Isis. "Many of the recent therapies under development or on the market to treat obesity have unacceptable safety profiles. Clearly there is a significant need for a treatment approach that can cause weight loss without deleterious side effects."... Isis Pharmaceuticals' Press Release -

Teva UK : generic anti-obesity drug Orlistat

12th December 2011 - Teva UK Limited launches generic anti-obesity drug Orlistat -

We are delighted to announce the first generic launch of Orlistat, generic equivalent to Xenical® (Orlistat) from Roche...

[...]

...“As the UK’s leading supplier of generics, we’re pleased not only to have the widest portfolio of our competitors, but also to show that we’re well-placed when it comes to innovation and being the first to market.”

Indication 

Orlistat is a generic version of prescription-only Xenical® from Roche and is indicated in conjunction with a mildly hypocaloric diet for the treatments of obese patients with a body mass index (BMI) greater or equal to 30kg/m2, or overweight patients (BMI ≥ 28kg/m2) with associated risk factors... Teva UK's Press Release -

Nestlé Health Science : Consensus panel calls for specialised nutritional therapy for the critically ill obese

September 13, 2011 - A newly published consensus report prepared by a panel of clinical experts, with sponsorship from Nestlé Health Science, reveals that there are opportunities to do more to manage the impact of obesity on the delivery of critical care, particularly in the area of nutrition therapy. With more than 25 percent of ICU patients considered to be obese or severely obese,1 the panel of clinical experts urges hospitals and medical professionals to adapt medical care traditionally designed to meet the needs of average-weight patients to the unique needs of the obese patient population. Patients with obesity, while heterogeneous as a population, are typically predisposed to greater morbidity, higher instances of infection and organ failure, and extended length of stay, all negative clinical outcomes that affect overall recovery.

“The lack of consistent standardized nutrition interventions for the critically ill patient with obesity means that some patients may be overfed and others may be underfed or malnourished. Some may never have their nutritional needs assessed. All of these scenarios can present problems with health outcomes and recovery rates,” said Dr Stephen McClave, M.D., professor of Medicine, University of Louisville, and moderator of the consensus panel.

The consensus report, published as a supplement to the September 2011 issue of the Journal of Parenteral and Enteral Nutrition (JPEN), explores multiple issues related to obesity in the critical care setting including the many challenges associated with applying standard nutrition therapy practice to the obese patient population. Areas of concern include assessment of nutritional status and nutrient requirements, as well as delivery of nutrients, including route of delivery, overfeeding of calories, underfeeding of protein and monitoring of feeding tolerance... Nestlé's Press Release -

Palatin : Phase 1 Trial for Obesity Compound in collaboration with AstraZeneca

August 4, 2011 – Palatin Technologies, Inc. (NYSE Amex: PTN) confirmed the commencement of a Phase 1 clinical trial of AZD2820, a subcutaneously-administered peptide melanocortin receptor partial agonist, under development as a single-agent therapy for the treatment of obesity. AZD2820 is a clinical candidate selected by AstraZeneca from its collaborative research program with Palatin Technologies. 

Obesity is a global problem, with the World Health Organization estimating that over 1.5 billion adults are overweight and over 500 million are obese. Worldwide obesity has more than doubled since 1980. A number of different metabolic and hormonal pathways are being evaluated by companies around the world in efforts to develop better treatments for obesity. Scientific research has established that melanocortin receptors have a role in eating behavior and energy homeostasis, and that some melanocortin receptor agonists decrease food intake and induce weight loss in animal studies.

The single center study is expected to enroll 90 subjects in a randomized, single-blind, placebo-controlled, Phase 1 trial in healthy male volunteers... Palatin Technologies' Press Release -