#Hong Kong #tirzepatide #Ascletis #ASC35

Ascletis Pharma Selects ASC35 for Clinical Development

Ascletis Pharma Inc. has made a significant stride in obesity treatment by selecting ASC35, a once-monthly, dual peptide agonist targeting the GLP-1 and GIP receptors, as its candidate for clinical development. This decision reflects Ascletis's commitment to innovation in the metabolic disease space, bolstered by promising preclinical findings.

ASC35: A Potential Game Changer

Research conducted in non-human primate (NHP) studies has highlighted impressive findings for ASC35. The average observed half-life was approximately 14 days, which is six times longer than that of tirzepatide, the current standard in the field. This extended half-life suggests that administration can potentially shift to once-monthly subcutaneous dosing for patients, enhancing the drug's appeal and usability compared to more frequent alternatives.

In addition to improved pharmacokinetics, ASC35 has demonstrated a potently enhanced effect compared to tirzepatide. In vitro examinations reveal that ASC35 is about four times more effective than tirzepatide at activating both the GLP-1 and GIP receptors. When tested in a diet-induced obese (DIO) mouse model, ASC35 resulted in a weight reduction of 33.6%, outperforming tirzepatide’s 19.6% loss by 71%.

This scalable and effective formula arises from Ascletis' proprietary technologies, namely the Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP). These technologies allow for precise adjustments in the release profiles and efficiency of peptide-based drugs, promising better patient outcomes through optimal dosing schedules.

Upcoming Steps for Indication Approval

Looking forward, Ascletis aims to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) for ASC35 in the second quarter of 2026. This step is crucial as it will enable the company to pave the way for clinical trials and further validate the compound's efficacy and safety in humans. Ascletis’ founder, Dr. Jinzi Jason Wu, expressed confidence in ASC35’s potential, highlighting its design for once-monthly administration as a “versatile and patient-friendly titration schedule.”

Future Developments and Combination Therapies

Beyond its monotherapy potential, Ascletis plans to explore combination therapies involving ASC35. The company intends to test ASC35 alongside ASC36, another once-monthly peptide agonist, to create comprehensive treatment options for cardio-metabolic diseases, including obesity and diabetes. Furthermore, combining ASC35 with ASC47, an adipose-targeted thyroid hormone receptor beta agonist, is also on the agenda, indicating Ascletis’s commitment to developing multi-faceted treatments for metabolic disorders.

Conclusion

The advancement of ASC35 symbolizes a major milestone for Ascletis Pharma as it seeks to establish itself as a leader in the biopharmaceutical sector focused on metabolism and weight management therapies. This innovative approach to drug development, prioritizing both efficacy and ease of patient use, positions ASC35 as a promising contender that could redefine treatment protocols for obesity and potentially other metabolic conditions. As the company prepares for its IND submission, the excitement in clinical circles is palpable, and many eyes are fixed on the upcoming results.

For more information about the ongoing developments at Ascletis Pharma, please visit Ascletis' official website.