#China #Hong Kong #Ascletis #ASC37 #Peptide Agonist

Ascletis Selects ASC37 for Clinical Development

Ascletis Pharma Inc., a biotech company headquartered in Hong Kong, has recently made a significant stride in the fight against obesity by selecting its first oral GLP-1R/GIPR/GCGR triple peptide agonist, known as ASC37, for clinical development. This innovative treatment aims to offer a more effective option for managing obesity, building upon the company’s prior successes with its technology.

Innovative Technology Behind ASC37

Ascletis has utilized its proprietary Peptide Oral Transport ENhancement Technology (POTENT) in developing ASC37. This advanced technology has enabled the oral tablets of ASC37 to achieve an impressive average absolute oral bioavailability of 4.2%. This figure signifies a remarkable enhancement compared to existing options, as it is approximately 9, 30, and 60 times more effective than semaglutide, tirzepatide, and retatrutide, respectively, when tested in head-to-head non-human primate studies.

The efficacy of the drug was further demonstrated through its drug exposure measurements, which revealed that ASC37 exhibits approximately 57 times more drug exposure than retatrutide in similar studies. Such compelling statistics underline the potential of ASC37 to potentially become a game-changer in the treatment of obesity.

Clinical Characteristics and Projections

The pharmacokinetic properties of ASC37 are noteworthy as well. Its average observed half-life stands at approximately 56 hours in non-human primate studies, suggesting that it can be administered once daily or even less frequently. This could greatly enhance patient compliance and convenience compared to therapies requiring more frequent dosing.

Additionally, the in vitro potency results show that ASC37 is significantly more effective than retatrutide for its target receptors—GLP-1R, GIPR, and GCGR—with improvements measured at approximately 5, 4, and 4 times stronger, respectively. These findings collectively reinforce ASC37's potential in addressing the treatment needs in obesity management.

Regulatory Plans and Future Developments

Ascletis is planning to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) within the second quarter of 2026, marking an essential next step in bringing this promising treatment to market. The company is optimistic that the submission will pave the way for effective treatment options for obesity and potentially other metabolic disorders.

Dr. Jinzi Jason Wu, the founder and CEO of Ascletis, expressed excitement regarding this development. He emphasized the company’s commitment to addressing unmet medical needs related to obesity treatment through their advanced R&D capabilities. The development of ASC37 aligns with Ascletis’ overall strategy of leveraging cutting-edge technology platforms, including Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD), to create a diverse portfolio of impactful therapies.

Conclusion

As the landscape of obesity treatment continues to evolve, Ascletis' selection of ASC37 marks a promising advancement within the biotech sector. With its unique formulation and enhanced bioavailability, ASC37 could very well set a new standard in the management of obesity. As clinical trials get underway, all eyes will be on Ascletis to see how this innovative new treatment performs in real-world applications, ideally leading to greater outcomes for individuals struggling with obesity.

For further updates, interested parties are encouraged to check Ascletis’ official communications leading up to the IND submission and subsequent developments.

About Ascletis Pharma Inc.

Ascletis is a biotechnology company committed to the development and commercialization of unique therapeutics for metabolic diseases, showcasing a robust pipeline that includes both small molecules and peptides. The company's shares are listed on the Hong Kong Stock Exchange under the ticker 1672.HK.

For more information, visit www.ascletis.com.