ASCLETIS-B (01672) has announced the receipt of an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for the Phase I clinical study of its drug candidate, ASC35.
ASC35 is a peptide-based, once-monthly subcutaneous injectable dual agonist targeting both the glucagon-like peptide-1 receptor (GLP-1R) and the glucose-dependent insulinotropic polypeptide receptor (GIPR), intended for the treatment of obesity. It is positioned as a potential best-in-class therapy.
The planned Phase I trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 following single and multiple ascending doses. The trial will enroll 84 participants who are either obese (with a body mass index, or BMI, of at least 30.0 kg/m²) or overweight (BMI of at least 27.0 kg/m²) with weight-related comorbidities.
The study is structured into two parts. Part A will be a single ascending dose (SAD) study of ASC35's self-assembled lipid depot (SALD) monthly formulation. Part B will be a multiple ascending dose (MAD), head-to-head study comparing the ASC35 SALD monthly formulation against the FDA-approved weekly formulation of tirzepatide.
In vitro experiments have demonstrated that ASC35 exhibits approximately four times greater agonist activity at both the GLP-1R and GIPR compared to tirzepatide. Based on all preclinical data, ASC35 shows superior efficacy per milligram of peptide relative to tirzepatide.
Initial Steps
"The FDA's IND approval for the ASC35 monthly formulation, developed using our proprietary SALD technology, represents a significant and exciting milestone for our obesity peptide pipeline," stated Dr. Jinzi J. Wu, Founder, Chairman, and CEO of ASCLETIS-B. "We are currently advancing multiple once-monthly to once-quarterly subcutaneous injectable peptides into the clinical stage."
Addressing Market Needs
Dr. Wu added, "The outstanding weight-loss potential of ASC35, combined with a more flexible and patient-friendly once-monthly subcutaneous dosing regimen, has the promise to address a major unmet need in the rapidly expanding obesity market."