ASC37o / Ascletis - LARVOL DELTA

Ascletis Announces Once-Monthly Subcutaneously Administered GLP-1R/GIPR/GCGR Triple Peptide Agonist, ASC37, Demonstrated Superior Weight Loss in a Diet-Induced Obese Mouse Model (PRNewswire) - "Following 11-day administration of ASC37 and tirzepatide at the same dose of 1 nmol/kg in DIO mice, ASC37 had statistically significant 88% greater relative body weight reduction compared to tirzepatide. Furthermore, ASC37 demonstrated up to 41.5% weight loss in a dose-dependent fashion in the DIO mice."

Preclinical • Obesity

Oral GLP-1R/GIPR/GCGR Triple Agonist Peptide: ASC37 (PRNewswire) - "In NHPs, the absolute oral bioavailability of semaglutide in Ascletis' POTENT formulation is 3-fold of that of semaglutide in its commercial SNAC (salcaprozate sodium) formulation; and the absolute oral bioavailability of tirzepatide in Ascletis' POTENT formulation is 9-fold of that of tirzepatide in the SNAC formulation...Utilizing the POTENT platform, ASC37 oral tablets achieved an average absolute oral bioavailability of 4.2%, approximately 30- and 60-fold higher than tirzepatide and retatrutide in the SNAC formulation, respectively, in head-to-head NHP studies. In addition, in NHP studies, ASC37 oral tablets exhibited an average observed half-life of approximately 56 hours, supporting once-daily or potentially less frequent oral dosing."

Preclinical • Obesity

Ascletis Selects a Next-Generation Once-Monthly Subcutaneously Administered GLP-1R/GIPR/GCGR Triple Peptide Agonist, ASC37, for Clinical Development (The Manila Times) - "In head-to-head non-human primate (NHP) studies, average observed half-life of ASC37 was approximately 17 days, 7-fold longer than retatrutide, which supports once-monthly subcutaneous (SQ) dosing in humans...Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC37 injection for the treatment of obesity in the second quarter of 2026...ASC37's average in vitro activity was approximately 5-, 4-, and 4-fold more potent than retatrutide for GLP-1R, GIPR and GCGR, respectively....'Expected initiation of our Phase I study in the second half of 2026 will be another step in our comprehensive strategy to improve the treatment options for people with obesity.'"

IND • New P1 trial • Preclinical • Obesity

Ascletis Selects Its First Oral GLP-1R/GIPR/GCGR Triple Peptide Agonist, ASC37, for Clinical Development (PRNewswire) - "ASC37 oral tablets' drug exposure, as measured by the area under curve (AUC), was approximately 57-fold of retatrutide's drug exposure in head-to-head NHP studies.... Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC37 oral tablets for the treatment of obesity in the second quarter of 2026."

IND • New molecule • Preclinical • Obesity