#China #Hong Kong #Ascletis #ASC30 #GLP-1R

Ascletis Unveils Remarkable ASC30: A Game Changer for Obesity Treatment

Ascletis Pharma Inc., based in Hong Kong, has made a significant advancement in obesity treatment with its small molecule GLP-1 receptor (GLP-1R) agonist, ASC30. Recently, in a U.S. Phase Ib clinical study, the ultra-long-acting subcutaneous depot formulation of ASC30 demonstrated an impressive observed half-life of 75 days. This breakthrough suggests that people struggling with obesity may benefit from a treatment that requires administration only once every quarter.

The Study and Findings

The Phase Ib study, identified under clinical trial number NCT06679959, evaluated the safety and efficacy of ASC30 among participants with a body mass index (BMI) of 30 kg/m2 or higher. Following a single subcutaneous injection of 100 mg of ASC30, it took a median of 17 days for the drug to reach peak concentration (Cmax) in the bloodstream. Importantly, this concentration decreased to 50% after approximately 75 days, confirming the medication’s extended half-life.

Dr. Jinzi Jason Wu, Founder and CEO of Ascletis, said, “Maintenance therapy addresses a truly unmet medical need in the realm of chronic weight management.” As patients typically seek to transition from more frequent drug dosages to less frequent options for long-term weight maintenance, ASC30’s once-quarterly administration could represent a paradigm shift for many.

Benefits Over Existing Treatments

The ASC30 formulation leverages Ascletis' proprietary Ultra-Long-Acting Platform (ULAP), designed for effective pharmacokinetics to enhance patient compliance. The quarterly injection schedule aligns well with patient preferences, especially after initial weight loss with weekly incretin medications. Furthermore, clinical data suggests that once-quarterly administration of ASC30 not only aids in maintaining weight but also minimizes the risk of weight rebound—a significant concern for many individuals.

In the same study, the tolerability of ASC30 was positively noted, with no significant gastrointestinal issues reported. Among the eight participants treated with ASC30, none experienced severe adverse gastrointestinal events such as vomiting or nausea. Comparatively, those administered a placebo showed higher rates of nausea (12.5%) and diarrhea (6.3%), which suggests that ASC30 may present a safer alternative.

Safety Profile

The Phase Ib trial revealed that participants experienced minimal side effects. No serious adverse events (SAEs) were reported, and even gastrointestinal-related adverse events were rated as Grade 1 in severity. Notably, ASC30 treatment did not show significant liver enzyme elevations, maintaining safety across various health metrics, laboratory tests, and physical exams over the 12-week observation period.

Table 1 below summarizes these findings, reinforcing ASC30's promising safety profile:

Future Directions

Following these encouraging results, Ascletis is pursuing further clinical evaluations to refine dosing strategies, and engagements with regulatory authorities are underway. The company is simultaneously investigating a monthly formulation of ASC30, which has also shown a promising half-life of 46 days, suggesting potential for effective monthly management of obesity.

With its innovative drug delivery approach, Ascletis aims to revolutionize obesity treatment through tailored therapy strategies that can significantly enhance patient outcomes. Established with a focus on developing potential best-in-class therapeutics for metabolic diseases, Ascletis is paving the way for transformative obesity management solutions.

For additional information on ASC30 and Ascletis' ongoing research and drug development efforts, please visit Ascletis.

Contact Information:
Peter Vozzo, ICR Healthcare
Phone: 443-231-0505 (U.S.)
Email: [email protected]
Ascletis Pharma Inc. PR and IR teams
Phone: +86-181-0650-9129 (China)