#Hong Kong #obesity #Ascletis #ASC30

Introduction

Ascletis Pharma Inc. has announced promising new data from its Phase Ib study of ASC30, a novel oral tablet designed for once-daily administration aimed at treating obesity. Conducted in the United States, this randomized, double-blind, placebo-controlled study provided early indicators of ASC30’s pharmacokinetic profile, showcasing its potential superiority over existing weight management medications.

Study Overview

The Phase Ib study evaluated the pharmacokinetics of ASC30 in participants with a body mass index (BMI) between 30 and 40 kg/m². The data revealed that ASC30 exhibited drug exposures (measured as area under the curve over 0-24 hours, or AUC0-24h) of 3,560 ng·h/mL for the 20 mg cohort and 5,060 ng·h/mL for the 40 mg cohort. These figures highlight a significant correlation between drug exposure levels and weight loss results. Participants in cohort 1 experienced an average weight reduction of about 4.5% over 28 days, while those in cohort 2 lost approximately 6.5%.

Comparison with Orforglipron

In a cross-trial comparison, the performance of ASC30 eclipsed that of orforglipron, an established once-daily oral capsule. Specifically, ASC30 demonstrated drug exposures that were approximately 2.3-fold to 3.3-fold greater than those of orforglipron, which reported a mere 3.6% weight reduction under similar conditions. Notably, while the 20 mg ASC30 group reported no incidents of vomiting, the orforglipron cohort faced an 18% intolerance rate—an encouraging sign for ASC30’s tolerability and safety profile.

Safety Profile

The study’s findings are particularly notable with respect to safety. Participants did not experience serious adverse events (SAEs) or Grade 3 and higher adverse events, showcasing ASC30's favorable tolerability. Critical laboratory parameters, including liver enzymes and vital signs, showed no concerning changes throughout the trial's duration. This strongly suggests that the drug's formulation and development strategies may contribute to its enhanced safety compared to competitors.

Expert Insights

Jinzi Jason Wu, the founder and CEO of Ascletis, expressed optimism regarding these results: "Based on recent clinical data, we observe that higher drug exposure correlates with greater weight loss in small molecule GLP-1 receptor agonists, including orforglipron. I am thrilled that our head-to-head study results translated effectively from non-human primates to human subjects, showing ASC30’s enhanced efficacy."

Future Steps

Encouraged by these findings, Ascletis has accelerated its research efforts. The company recently completed the enrollment of 125 participants in a Phase IIa study focusing on the efficacy of ASC30 among individuals facing overweight issues. Topline results from this study are anticipated by the end of 2025, potentially paving the way for ASC30 to become a competitive option in the obesity treatment landscape.

Conclusion

With its unique characteristics and encouraging early data, ASC30 shows promise as a leading contender in obesity management. As Ascletis Pharma continues its development trajectory, the pharmaceutical community eagerly awaits further insights to determine whether the ASC30 tablet could ultimately change the therapeutic paradigm for those struggling with obesity.