-- ASC50 is an in-house discovered and developed oral small molecule interleukin-17 (IL-17) inhibitor for the treatment of multiple autoimmune and inflammatory diseases, including psoriasis .

-- Following oral dosing in non-human primates, ASC50 demonstrated higher drug exposure, longer half-life and lower clearance than an oral small molecule IL-17 inhibitor comparator, which is currently in the clinical development.

-- Preclinical data, including higher oral exposure, longer half-life and  strong efficacy, support ASC50 as a potential best-in-class oral agent for psoriasis.

-- The Company expects to initiate dosing in a Phase I trial in patients with mild-to-moderate plaque psoriasis in the third quarter of 2025.  

HONG KONG , May 22, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for a Phase I trial for ASC50 for the treatment of mild-to-moderate plaque psoriasis. ASC50 is an in-house discovered and developed oral small molecule inhibitor targeting interleukin-17 (IL-17), an important biologically and commercially validated target for multiple autoimmune and inflammatory diseases, including psoriasis.

Following oral dosing in non-human primates, ASC50 demonstrated higher drug exposure, longer half-life and lower clearance than an oral small molecule IL-17 inhibitor comparator, which is currently in the clinical development. Furthermore, ASC50 demonstrated strong efficacy in a psoriasis animal model. These preclinical data support ASC50 as a potential best-in-class once-daily oral drug candidate for the treatment of psoriasis.

The Phase I clinical trial of ASC50 is a randomized, double-blind, placebo-controlled study and will be conducted at multiple sites in the U.S. Dosing of patients with mild-to-moderate plaque psoriasis is expected to start in the third quarter of 2025.

"We are excited and encouraged by the preclinical data of ASC50 as it is the first oral small molecule drug candidate in immunology arisen from our Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) Platform," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "The IND clearance of ASC50 marks a new milestone for Ascletis in autoimmune and inflammatory diseases. We are continuing to work on differentiated agents including oral drugs and once-monthly or less frequent subcutaneously injectables to address unmet medical needs in multiple key therapeutics areas."

About Ascletis Pharma Inc.

Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis is focused on metabolic and other diseases by addressing unmet medical needs from a global perspective. Ascletis has multiple clinical stage drug candidates in its metabolic disease pipeline.

For more information, please visit www.ascletis.com.

Contact：

Peter Vozzo

ICR Healthcare

443-231-0505 (U.S.)

Peter.vozzo@icrhealthcare.com

Ascletis Pharma Inc. PR and IR teams

+86-181-0650-9129 (China)

pr@ascletis.com 

ir@ascletis.com 

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SOURCE Ascletis Pharma Inc.