Ascletis Reports Promising Results for ASC50 in Phase I Study: A New Era for IL-17 Inhibitors

Ascletis Reports Significant Progress in IL-17 Inhibition with ASC50

Ascletis Pharma Inc. has announced promising topline results from a Phase I clinical study of ASC50, a groundbreaking oral small molecule inhibitor aimed at interleukin-17 (IL-17) for treating autoimmune diseases. The trial demonstrated that ASC50 exhibits a robust pharmacokinetic profile, enhanced target engagement, and an excellent safety tolerance level.

Overview of the Clinical Trial

Conducted in the United States, this randomized, double-blind, placebo-controlled study engaged forty-six healthy participants. These individuals received varying doses of ASC50 (ranging from 10 mg to 600 mg) or a placebo. The primary objectives of the research included assessing the safety, pharmacokinetics, and the way ASC50 engages IL-17A, an important inflammatory marker associated with several autoimmune conditions.

Key Findings

The trial unveiled the elimination half-life of ASC50, recorded at 43, 89, 91, 87, 104, and 85 hours across different doses, indicating potential for once-daily or even once-weekly dosing regimens. Significantly, the administration of a single oral dose highlighted robust target engagement, as evidenced by elevated IL-17A plasma levels that persisted up to seven days post-administration for higher doses.

Moreover, the pharmacokinetic analysis revealed a dose-proportional profile, confirming consistency in drug behavior across varying concentrations. Notably, when compared against LY4100511 (DC-853) - another IL-17 inhibitor in development - ASC50 demonstrated superior bioavailability, longer half-life, and reduced clearance in non-human primate tests.

The safety profile of ASC50 was particularly encouraging, with all observed adverse events classified as mild and transient, and no serious side effects reported. This robust safety tolerance further enhances the drug's potential as a viable treatment option.

Path Forward: Next Phases of Development

Following these positive results, ASC50 is set to advance into the next phase of clinical trials that will involve multiple ascending doses, specifically targeting individuals suffering from mild to moderate plaque psoriasis. This progression into further studies underscores Ascletis’ commitment to delivering innovative therapeutic options for conditions driven by IL-17 hyperactivity.

Technological Innovations Behind ASC50

What sets ASC50 apart is its development through Ascletis’ proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) technology. This approach is aimed at producing high-quality therapeutic candidates with enhanced efficacy against various inflammatory diseases.

Dr. Jinzi Jason Wu, founder and CEO of Ascletis, expressed optimism about the findings, stating, “These data demonstrate a favorable safety profile as well as a dose-dependent and differentiated pharmacokinetic profile of ASC50.” Wu’s remarks highlight the foundational role of AI technology in propelling pharmaceutical advancements within the immunology spectrum.

Conclusion

With these encouraging topline results, ASC50 appears positioned to revolutionize treatment approaches for inflammatory and autoimmune diseases associated with IL-17. As researchers and clinicians await further developments, the prospects for ASC50 and Ascletis Pharma seem exceptionally promising. The company will be holding a conference call, detailing these findings, on December 15, 2025, allowing stakeholders and the scientific community an opportunity to inquire further into this significant advancement.

For additional insights on Ascletis’ innovative approaches and drug developments, visit Ascletis' official website.