Unigene : Promising Preclinical Results in Its Obesity Peptide Program

Dec 17, 2009 - Unigene Laboratories, Inc. (OTCBB: UGNE) announced that it has selected a lead peptide compound, designated UGP281, from its obesity program for development. In a short-term study reported at the Keystone Symposium Conference on "Obesity: Novel Aspects of the Regulation of Body Weight" last January, a previously developed compound, orally-administered UGL269, reduced food intake in dogs by up to 50% and correspondingly reduced body weight. Subsequent studies by Unigene have led to the development of UGP281, a peptide modeled after naturally-occurring hormones which is significantly more potent than UGL269 and achieves the same reduction in food consumption at a lower dose. Importantly, in comparative animal studies at the same dose, UGP281 was at least 3-fold more effective in reducing food consumption than certain other peptide compounds that are currently in later-stage clinical development by third parties for accelerated weight loss. In addition, there were no overt signs of toxicity. The pronounced reductions in feeding behavior, as well as the weight of the animals after daily administration of this peptide, persisted over several weeks of dosing. The peptide has the additional advantages that it can be delivered orally using Unigene's Enteripep(R) technology and manufactured using Unigene's Secrapep(R) technology... Unigene's Press Release -

Shionogi : positive...results from year-long studies of velneperit, a novel NPY Y5 receptor antagonist being investigated for the treatment of obesity

February 17, 2009 - Shionogi & Co, Ltd. announced that two distinct year-long studies of velneperit, a novel neuropeptide Y (NPY) Y5 receptor antagonist also known as S-2367, each met their primary endpoint of demonstrating a statistically significant reduction in body weight. These clinical studies further demonstrate the potential for the NPY Y5 receptor as a target for obesity treatment.
Shionogi assessed the long term efficacy and safety of velneperit over the course of one year in two distinct studies, comprising a total randomized population of 1,566 obese subjects across 80 centers in the United States. Each respective study assessed the efficacy and safety of velneperit under different reduced calorie diet and low calorie diet conditions. In the strongest performing group relative to placebo across the two studies, subjects undergoing velneperit treatment of 800mg once-daily in combination with a reduced calorie diet responded with 5% or greater weight loss at a percentage nearly three times higher than those on placebo (35% vs. 12%). In addition, velneperit treatment resulted in statistically significant differences with respect to secondary parameters such as decreased waist circumference and improved serum lipid profile. In terms of safety, velneperit was well tolerated in all groups over the course of one year treatment, a finding consistent with subject experience in previous clinical studies. A full analysis of the current study data, including secondary efficacy endpoints as well as safety and laboratory parameters is currently underway...[PDF] Shionogi's Press Release -

Kemeta and Kronos Science Laboratories : Fat Metabolism Studies Collaboration

October 15, 2009 - Kemeta, LLC and Kronos Science Laboratories announce their collaborative agreement to study fat metabolism through a series of human clinical studies. Kemeta is commercializing a patented palm-size breath analyzer that specifically and immediately detects if, and at what rate, the user is burning fat.

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The Kemeta product will have application in the prevention of weight related diseases such as type 2 diabetes, hypertension and cardiovascular disease as well as the optimization of personal health and fitness programs. The U.S. Center for Disease Control studies show that people with pre-diabetes can prevent or delay full blown type 2 diabetes by losing at least 7% of their body weight and engaging in moderate physical activity at least 150 minutes per week... Kemeta's Press Release -

Halsa Pharmaceuticals : ZAG Demonstrates Weight Loss, Rise in Temperature and Reduction of Diabetes Symptoms in Preclinical Studies at Obesity 2009...

October 26, 2009 - Houston-based Halsa Pharmaceuticals, Inc., a biotechnology company developing therapeutics for the treatment of obesity, diabetes, cachexia and other metabolic diseases, announced results from preclinical studies demonstrating that recombinant human Zinc-α2-glycoprotein (ZAG) induced a progressive loss of body weight in mice of 3.5g in five days, together with a rise in temperature of 0.4°C, suggesting an increase in energy expenditure. In addition, ZAG produced a normalization of the diabetic glucose tolerance curve after three days of treatment, suggesting that ZAG may have a therapeutic application in the treatment of obesity and Type 2 diabetes. The results from this study were presented at Obesity 2009, the 27th Annual Scientific Meeting of The Obesity Society, one of the largest scientific conferences in the field of obesity, being held in Washington, D.C. October 24-28... [PDF] Halsa Pharmaceuticals' Press Release -

GI Dynamics : Novel Non-Surgical Therapy Dramatically Increases Weight Loss in Obese Patients; Results from Pilot Clinical Study Presented at ASMBS

June 26, 2009 – EndoBarrier ™ Gastrointestinal Liner Plus Flow Restrictor Facilitates Substantial Excess Weight Loss; Median %EWL of 39.6 Percent - GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and obesity, announced results from a pilot clinical study which demonstrated the substantially enhanced weight loss effects of combining the company’s EndoBarrier Gastrointestinal Liner with a new EndoBarrier Flow Restrictor. The EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet of the stomach and is designed to delay gastric emptying, an additional mechanism which adds to the therapeutic effects of the liner. The results were presented at the 26th annual meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS)... (Word) GI Dynamics' Press Release -

Boehringer Ingelheim and DeveloGen AG : agreement in the field of diabetes, obesity and the metabolic syndrome

May 13th, 2009 - Boehringer Ingelheim and DeveloGen AG, announced the signing of an asset sale and purchase and collaboration agreement in the field of diabetes, obesity, the metabolic syndrome and other insulin resistance associated disorders...

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About DeveloGen
DeveloGen AG is a biopharmaceutical company engaged in the discovery and development of novel therapeutics for the treatment of metabolic and endocrine diseases. The Company has a highly innovative and deep preclinical discovery pipeline addressing the key drivers in the development of diabetes and obesity such as insulin resistance and loss of insulin-producing beta cells...

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About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees... [PDF] DeveloGen's Press Release - Boehringer Ingelheim's Press Release -

Zydus Cadila : ‘ZYD1’ – a novel candidate to treat Diabetes and Obesity

June 04, 2009 - Zydus Cadila, a global healthcare provider and one of India’s leading healthcare companies, announced the filing of the IND application for ZYD1 - a novel GLP-1 agonist molecule with the DCGI. Designed and developed at the Zydus Research Centre, ZYD1 is a novel candidate in the class of antidiabetic agents known as incretin mimetics and has displayed a better efficacy and safety profile.
Incretin mimetics are poised to dominate the future of anti-diabetic therapy and presents a huge opportunity in bridging unmet medical needs that still continues to dodge the treatment and care of diabetes. The new class of drugs called incretins came to the fore in May 2005 when the world’s first GLP-1 agonist was approved by the USFDA.
ZYD1 has demonstrated beneficial effects in preclinical animal models on glucose reduction, HbA1c reduction and added benefits of weight loss. ZYD1 displayed a differentiated preclinical safety profile with no nausea-like symptoms and absence of antibody generation in the preclinical studies...

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...The Zydus Research Centre has over 20 discovery programmes ongoing with several candidates in the pre-clinical development stage focused on metabolic, cardiovascular, pain and inflammation therapeutic areas. With over 375 research professionals spearheading its research programme, Zydus has inhouse capabilities to conduct discovery research from concept to IND enabling pre-clinical development and human proof-of-concept clinical trials... [PDF] Zydus Cadila's Press Release -

AMRI : New Obesity Treatment toward IND Submission

June 2, 2009— AMRI (NASDAQ: AMRI) announced the selection of a compound from its proprietary obesity treatment research program for advanced preclinical testing, with the goal of submitting an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) in 2010.

AMRI's drug candidate is a novel MCH-1 receptor antagonist offering a promising new approach for the treatment of obesity. Melanin concentrating hormone (MCH) is a potent appetite stimulating peptide known to exert an effect on food intake and body weight regulation. In preclinical disease models, AMRI's small molecule antagonists of the MCH-1 receptor have demonstrated efficacy in rodent models of obesity, delivering weight loss that rivals currently available therapeutics, suggesting the potential for improved therapy in humans.

Pending favorable results in toxicity and safety pharmacology testing, AMRI estimates that it will submit an IND for this compound in the first half of 2010. Subject to FDA review, the submission of an IND would allow subsequent initiation of Phase I human clinical trials... AMRI's Press Release -

Emisphere Technologies : Encouraging Data from Independent Clinical Study Assessing the Effects of Oral GLP-1 and PYY3-36, Combined with Eligen(R) ...

May 26, 2009 - Encouraging Data from Independent Clinical Study Assessing the Effects of Oral GLP-1 and PYY3-36, Combined with Eligen(R) Technology on Appetite Suppression- Emisphere Technologies, Inc. (NASDAQ: EMIS) announced data from a clinical study designed to assess the effect of oral administration of two peptides, GLP-1 and PYY3-36, utilizing Emisphere's Eligen(R) Technology on appetite suppression. The study was conducted at the University Hospital in Basel, Switzerland by Professor Christoph Beglinger, of the Clinical Research Center, Department of Biomedicine Division of Gastroenterology, andDepartment of Clinical Pharmacology and Toxicology at the hospital.

The randomized, double-blind, placebo-controlled trial was conducted in 16 normal weight males between the ages of 18 and 40. The study was designed to investigate the effects of orally administered GLP-1 and PYY3-36 formulated with Emisphere's Sodium N-[8-(2-hydroxybenzoyl) Amino] Caprylate ("SNAC") carrier and their potential effect in the control of food intake and satiety. Prior studies have shown the ability of both peptides to reduce appetite and food consumption in healthy subjects and in patients with obesity... Emisphere Technologies' Press Release -