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 -