Ascletis Pharma's ASC35 Set for Q2 2026 FDA IND Submission
Ascletis Pharma Inc. is set to submit an Investigational New Drug Application (IND) for its novel drug candidate ASC35 to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026. ASC35, a once-monthly subcutaneously administered GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual peptide agonist, has shown promising results in preclinical studies.
ASC35 demonstrated a significant reduction in body weight in diet-induced obese (DIO) mice, outperforming tirzepatide by 71%. It reduced body weight by 33.6%, compared to tirzepatide's 19.6%. This increased efficacy is supported by ASC35's approximately 4-fold greater potency for both GLP-1R and GIPR in vitro.
ASC35's extended half-life, around 14 days in non-human primates, is 6-fold longer than tirzepatide. This, along with its higher bioavailability, enables once-monthly subcutaneous dosing. Ascletis' AISBDD and ULAP technologies facilitated the development of this ultra-long-acting peptide.
The company plans to develop ASC35 as a monotherapy and in combination with other drugs, including ASC36 and ASC47, for treating cardio-metabolic diseases like obesity, diabetes, and MASH.
Ascletis' upcoming IND submission for ASC35 marks a significant step towards potentially treating obesity and related conditions. With its enhanced efficacy and extended half-life, ASC35 shows promise as a once-monthly treatment option. Further clinical development will determine its full potential in managing cardio-metabolic diseases.
