AI-discovered IL-17 inhibitor from Ascletis Pharma shows best-in-class potential

Positive topline results from Hong Kong-based Ascletis Pharma’s ongoing phase I US clinical trial indicate the best-in-class potential of its oral small molecule IL-17 inhibitor ASC50.

The drug candidate was developed using the biotech’s artificial intelligence-assisted structure-based drug discovery (AISBDD) technology.

This study assessed the safety, tolerability, pharmacokinetics and target engagement of ASC50 tablets in participants with mild to moderate plaque psoriasis, and in forty-six healthy participants, with matching placebo. Positively, no serious adverse events (SAEs) were reported.

Clinical findings showed elevated plasma interleukin-17A (IL-17A) levels, which continued until day 7 for higher doses of ASC50, of which the highest was 600mg. This supports an oral dosing regimen of either once-daily or once per week, simplifying the administration burden on patients. Other doses assessed were: 10mg, 30mg, 100mg, 200mg and 400mg.

Advancing treatment options for autoimmune and inflammatory diseases

Jinzi Jason Wu, PhD, Founder, Chairman and CEO of Ascletis, said: “These data demonstrate a favourable safety profile as well as a dose-dependent and differentiated pharmacokinetic profile of ASC50.

“We are encouraged by these data as ASC50 is the first oral small molecule drug candidate in immunology developed from our artificial intelligence-assisted structure-based drug discovery (AISBDD) technology. These findings underscore ASC50’s potential as a best-in-class oral small molecule IL-17 inhibitor.”

The firm has progressed development of ASC50 to evaluate its potential through multiple ascending doses.

Recent progress in the psoriasis treatment landscape includes approval of Johnson & Johnson’s Tremfya (guselkumab) in September as the first IL-23 inhibitor to be authorised for paediatric plaque psoriasis and active psoriatic arthritis in the US.

Following the FDA’s approval, Dr Vimal Hasmukh Prajapati, Clinical Associate Professor, University of Calgary and study investigator, noted that there still is a significant gap in available therapies for these immune-mediated diseases.