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News|Articles|May 22, 2025

FDA Clears Investigational New Drug Application for Ascletis’ Oral IL-17 Inhibitor in Mild-to-Moderate Plaque Psoriasis

Clearance of ASC50 paves the way for a Phase I trial in patients with mild-to-moderate plaque psoriasis.

Key Takeaways

  • FDA Clears First Oral IL-17 Inhibitor from Ascletis’ AI Platform
    Ascletis Pharma’s ASC50 becomes the first oral interleukin (IL)-17 inhibitor developed using AI-assisted structure-based drug discovery to receive FDA investigational new drug clearance for mild-to-moderate plaque psoriasis.
  • ASC50 Demonstrates Promising Preclinical Pharmacokinetics
    In non-human primate studies, ASC50 outperformed a clinical-stage oral IL-17 comparator with extended half-life, increased drug exposure, and reduced clearance—supporting its potential as a next-generation oral therapy.
  • Psoriasis Market Set to Reach $68B by 2034
    With psoriasis prevalence rising and patient demand for oral alternatives growing, the global market is projected to grow at an 8% compound annual growth rate, making ASC50’s development a timely move.

The FDA has granted clearance to Ascletis Pharma’s investigational new drug (IND) application for ASC50, an oral small molecule inhibitor of interleukin (IL)-17, allowing the company to initiate a Phase I clinical trial in the United States. The trial will assess the safety, tolerability, and pharmacokinetics of ASC50 in patients with mild-to-moderate plaque psoriasis, a chronic autoimmune condition that affects millions of individuals worldwide.

What Makes ASC50 a Potential Breakthrough in Psoriasis Treatment?

According to Ascletis, ASC50 is the first oral IL-17 inhibitor emerging from its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) platform. The therapy is designed to selectively target the IL-17 pathway, a well-established driver of inflammatory and autoimmune diseases such as psoriasis.1

"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 Platform," said Jinzi Jason Wu, PhD, founder, chairman, CEO, Ascletis, in a press release.

Promising Preclinical Data Support ASC50’s Advancement

Preclinical studies in non-human primates showed that ASC50 achieved favorable pharmacokinetic properties compared to a clinical-stage oral IL-17 comparator. These included increased drug exposure, extended half-life, and reduced clearance, as well as robust efficacy in animal models of psoriasis.

These data support the compound’s potential as a differentiated oral treatment option for patients with autoimmune skin disorders, according to Ascletis. The Phase I study will be a randomized, double-blind, placebo-controlled trial conducted across multiple clinical sites in the United States. Patient enrollment and dosing are expected to begin in the third quarter of 2025.1

Market Opportunity for Psoriasis Treatments Continues to Grow

According to Precedence Research, the global psoriasis treatment market size is expected to reach an estimated $68.24 billion by 2034, expanding at a compound annual growth rate of 8% from 2025.2

Psoriasis Prevalence and Demographics in the United States

According to the National Psoriasis Foundation, 3% of the US adult population over 20 years of age is currently living with a form of psoriasis, with an estimated 600,000 undiagnosed. Females have a slightly higher prevalence of 3.2%, while males have a prevalence of 2.8%.

By race and ethnicity, White people have the highest prevalence at 3.6%, followed by Asians at 2.5%, Blacks at 1.5%, and people with a Hispanic background at an estimated 1.9% prevalence. The chance of getting psoriasis increases with age, with those between 50 and 59 years of age experiencing a prevalence of 4.3%. However, prevalence decreases in people over 70 years of age, with a 3.9% prevalence. In adults between 20 and 29 years of age, the prevalence is 1.6%.3

Ascletis Eyes Future Pipeline with Oral and Long-Acting Therapies

“The IND clearance of ASC50 marks a new milestone for Ascletis in autoimmune and inflammatory diseases,” Wu said in the press release. “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."

References

1. Ascletis Announces U.S. FDA Clearance of IND Application for Its Oral Small Molecule IL-17 Inhibitor, ASC50, for the Treatment of Psoriasis. PR Newswire. May 22, 2025. Accessed May 22, 2025. https://prnmedia.prnewswire.com/news-releases/ascletis-announces-us-fda-clearance-of-ind-application-for-its-oral-small-molecule-il-17-inhibitor-asc50-for-the-treatment-of-psoriasis-302462995.html

2. Psoriasis Treatment Market Size, Share and Trends 2025 to 2034. Precedence Research. May 12, 2025. Accessed May 22, 2025. https://www.precedenceresearch.com/psoriasis-treatment-market

3. Prevalence of Psoriasis. National Psoriasis Foundation. Accessed May 22, 2025. https://www.psoriasis.org/prevalence-of-psoriasis/#:~:text=Psoriasis%20affects%20an%20estimated%203.0,%25)%20and%20females%20(3.2%25).

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