Metabolics Pharma Announces Positive Top-Line Results from Phase 1a Clinical Trial of ENT-03 in Obese and Diabetic Subjects
ENT-03 was safe and well tolerated at all evaluated doses, with positive efficacy trends
DOYLESTOWN, Pa., June 25, 2025--(BUSINESS WIRE)--Metabolics Pharma ("Metabolics"), a privately held, Doylestown-based, clinical-stage biopharmaceutical company pioneering novel treatments for metabolic diseases, today announced top-line data from a Phase 1a clinical trial of its drug candidate, ENT-03, in obese and diabetic patients. ENT-03 was found to be safe and well tolerated at all doses evaluated as presented at the American Diabetes Association 85th Scientific Sessions on June 22, 2025. The study results showed positive trends for both weight reduction and increased insulin sensitivity at higher tested doses.
ENT-03 is a novel, centrally acting aminosterol with Protein Tyrosine Phosphatase 1B (PTP1B) inhibitory activity, which normalizes glucose, improves insulin sensitivity, and causes weight loss by acting on brain circuits that regulate energy and metabolism. In addition to the clinical trial results, ENT-03 is effective as a monotherapy and has an additive effect in combination with GLP1 agonists in animal models. ENT-03 also demonstrates durable weight loss and glucose and insulin normalization after therapy cessation.
"Our first-in-human study has demonstrated that ENT-03 is safe and very well tolerated and showed positive trends in both weight loss and insulin sensitivity that are consistent with what we have seen in preclinical in vivo studies," said Richard Larson, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of Metabolics Pharma. "We are planning a Phase 1b study to evaluate dosing regimens, which we expect to initiate in the second half of 2025."
The Phase 1a clinical trial was a single ascending dose study evaluating seven dose cohorts of ENT-03 in healthy obese subjects and obese subjects with type 2 diabetes (T2D). ENT-03 was administered subcutaneously (SQ) at six different doses. The primary endpoint was safety and tolerability and pharmacokinetic data. Secondary endpoints included fasting blood glucose, fasting insulin, lipid levels, and change in body weight at 7 days. More information can be found on clinicaltrials.gov.
ENT-03 was very well tolerated and efficacy endpoints showed trends toward weight loss at higher doses for both obese and obese/T2D subjects, along with improvement in insulin sensitivity.
About Metabolics PharmaMetabolics Pharma develops novel therapies for the treatment of metabolic diseases including obesity, type 2 diabetes, and MASH. The Company's lead compound, ENT-03, in development for the treatment of type 2 diabetes and obesity, increases insulin sensitivity by acting at the level of the brain. ENT-03 has completed a Phase 1a clinical trial and will begin a Phase 1b clinical trial in the second half of 2025. For more information, please visit www.metabolicspharma.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250625436712/en/
Contacts
Company contact: Richard Larson, M.D., Ph.D.Chief Executive Officer, Chief Medical Officer, and Chairman of the BoardJohn DessoukiChief Financial Officerj.dessouki@metabolicspharma.com
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