Revolutionizing Obesity Treatment with ASC37
Ascletis Pharma Inc. is making significant strides in the field of obesity treatment with the selection of ASC37 oral tablets as their first oral GLP-1R/GIPR/GCGR triple peptide agonist for clinical development. This groundbreaking drug candidate is designed to provide effective treatment options for individuals struggling with obesity, leveraging Ascletis' proprietary Peptide Oral Transport Enhancement Technology (POTENT) that greatly enhances oral bioavailability.
ASC37: A Breakthrough Drug Candidate
ASC37 oral tablets have shown remarkable performance in non-human primate studies. The average absolute oral bioavailability reached 4.2%, which is significantly higher—approximately 9-fold, 30-fold, and 60-fold—compared to established competitors like semaglutide, tirzepatide, and retatrutide, respectively. This impressive metric highlights ASC37's potential as a highly effective treatment option.
Enhanced Drug Exposure
The drug exposure of ASC37, assessed by the area under the curve (AUC), was found to be about 57-fold more than that of retatrutide in similar study conditions. This finding underscores the strong efficacy and bioavailability of ASC37, making it a hopeful candidate among obesity treatments.
Dosing Schedules That Fit Patients’ Lives
The clinical studies indicate an average half-life of approximately 56 hours for ASC37 oral tablets, supporting the possibility of once-daily dosing and potentially less frequent treatment schedules. Such convenience is crucial for patient compliance and long-term success in managing obesity.
Potential Impact on Obesity Treatment
Jinzi Jason Wu, Ph.D., Founder, Chairman, and CEO of Ascletis, expressed enthusiasm about the selection of ASC37, asserting that it reflects the company's robust research and development capabilities. He highlighted Ascletis' commitment to addressing the unmet needs of obesity treatment, leveraging innovative technology platforms such as Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and POTENT technology.
ASC37's in vitro activity demonstrates its superiority over retatrutide, being approximately 5-, 4-, and 4-fold more potent in targeting GLP-1R, GIPR, and GCGR, respectively. Such potency is expected to translate into higher efficacy and better outcomes for patients.
Future Directions and Submission Plans
Looking ahead, Ascletis plans 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 upcoming quarters. The anticipated timeline shows that this application could be submitted as early as the second quarter of 2026, reflecting fast-tracked progress toward potential market availability.
To engage with stakeholders about ASC37 and its clinical development, Ascletis will host a conference call in Mandarin, scheduled at 10:00 a.m. China Standard Time on a designated date in the future. This proactive communication approach exemplifies Ascletis' dedication to transparency and collaboration in their research efforts.
About Ascletis Pharma Inc.
Ascletis Pharma Inc. is a fully integrated biotechnology company dedicated to developing groundbreaking therapeutics aimed at treating various metabolic diseases. With its suite of innovative technologies, including AISBDD and POTENT, Ascletis focuses on creating first-in-class drugs that address critical complexities within the healthcare landscape. Their promising portfolio includes not only ASC37 but also other candidates designed to improve chronic weight management.
Frequently Asked Questions
What is ASC37?
ASC37 is a novel oral GLP-1R/GIPR/GCGR triple peptide agonist developed by Ascletis Pharma for treating obesity.
How does ASC37 compare to existing treatments?
ASC37 has shown significantly higher bioavailability and drug exposure compared to established medications like semaglutide and retatrutide.
When is the FDA submission expected?
Ascletis plans to submit an IND for ASC37 to the FDA in the second quarter of 2026.
What advantages does ASC37 offer?
ASC37 offers higher potency and the possibility for less frequent dosing, enhancing patient compliance in obesity management.
What technologies support ASC37's development?
ASC37 development leverages technologies like Peptide Oral Transport Enhancement Technology (POTENT) and Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD).
