Ascletis Pharma Inc. (ASCLF.PK) today announced positive topline data from its U.S. Phase I study of ASC50, an oral IL-17 inhibitor in development for plaque psoriasis, showing strong target engagement and a pharmacokinetic profile that supports once-daily or potentially once-weekly oral dosing.
Interleukin-17 (IL-17) is a biologically validated target for multiple autoimmune and inflammatory diseases, including psoriasis. Current therapies are largely injectable biologics, leaving a gap for oral alternatives.
The randomized, double-blind, placebo- controlled Phase I trial enrolled 46 healthy participants who received ascending doses of ASC50 ranging from 10 mg to 600 mg. The study met its objectives of safety, tolerability, pharmacokinetics, and target engagement.
The elimination half-life ranged from 43 to 104 hours across dose levels, supporting extended dosing intervals. ASC50 showed strong target engagement with elevated plasma IL-17A levels sustained through day 7 at higher doses. Pharmacokinetic analysis confirmed dose-proportional exposure from 10 mg to 600 mg. Safety outcomes were favourable, with all adverse events mild and transient, no serious adverse events reported, and no hepatic signals detected.
In non-human primate head-to-head studies, ASC50 demonstrated higher oral bioavailability, longer half-life, and lower clearance compared to LY4100511 (DC-853), another oral IL-17 inhibitor in development.Based on these findings, ASC50 has advanced into a multiple ascending dose study in patients with mild to moderate plaque psoriasis. The drug, discovered in-house using Ascletis' Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) platform, is protected by U.S. and global patents through 2043.
"These data demonstrate a favorable safety profile as well as a dose-dependent and differentiated pharmacokinetic profile of ASC50," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis. "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."
ASCLF.PK has traded between $0.23 and $2.29 over the past year. The stock closed Friday's trading at $2.03.
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