February 1, 2023 – Enterin Announces ENT-03 Benefit in MASH

PHILADELPHIA, February 1 , 2024 – Enterin Inc., a privately held, Philadelphia-based, clinical-stage biopharmaceutical company pioneering novel treatments for neurodegenerative and metabolic diseases, announces that it has recently shown that its drug ENT-03 shows significant benefit in metabolic dysfunction-associated and non-alcoholic fatty liver disease, also known as fatty liver, in addition to sustaining weight loss, lowering blood sugar, and improving insulin sensitivity in comparison to semaglutide.

“ENT-03 therapy clearly improves metabolic dysfuction-associated steatosis hepatitis (“MASH”), said Richard Larson, M.D., Chief Medical Officer of Enterin. “Our data indicates that MASH induced by obesity and diet is markedly improved with ENT-03 therapy and those improvements persist after therapy is completed.

ENT-03 is a novel, endogenous, centrally acting mammalian aminosterol with Protein Tyrosine Phosphatase 1B (PTP1B) inhibitory activity, which normalizes glucose and causes weight loss by acting on brain circuits that regulate energy and metabolism. In obese, diabetic mice, ENT-03 rapidly lowers blood glucose, reduces food intake and adiposity, eliminates liver fat, and improves liver function.

The current preclinical study demonstrates that ENT-03 and semaglutide result in approximately equivalent weight loss over 10 weeks of therapy. However, after the cessation of therapy, weight loss sustains more than twice the length of time with ENT-03 versus semaglutide therapy. Most impressive is the marked decrease in liver size with ENT-03 in comparison to semaglutide therapy, and this improvement persists at least four months after therapy cessation and while on a high fat, high calorie diet that promotes weight gain. Concurrent with this improvement in liver disease, there is additionally sustained improvement in markers of insulin sensitivity in ENT-03 treatment versus semaglutide.

“ENT-03 represents a novel drug that may be taken as an alternative to currently GLP-1 agonists or in combination. We believe that ENT-03 will have a substantial impact on the obesity drug market since it has benefits beyond weight loss,” said David McCullough, Chief Executive Officer of Enterin.

Phase 1 studies in obese and diabetic subjects are currently in progress (IND155001). Results of the first-in-human, randomized, double-blind, single ascending dose study involving approximately 49 subjects with obesity with or without Type 2 diabetes are expected to be available in mid-2024.

ENT-03 is Enterin’s second compound in clinical trials. The first compound, ENT-01, has completed a successful randomized Phase 2b study in patients with Parkinson’s disease (https://www.acpjournals.org/doi/10.7326/M22-1438).