Ascletis Announces Positive Results from 28-Day Proof-of-Concept Clinical Study in U.S. for ASC50, a First-in-Class and Best-in-Class Oral Small Molecule IL-17A Inhibitor for the Treatment of Plaque Psoriasis

- 48.9% placebo-adjusted reduction in psoriasis area and severity index (PASI) score achieved in mild-to-moderate plaque psoriasis patients with once-daily 200 mg 28-day treatment.

- Steady-state elimination half-life after 28-day treatment in patients was 6.5 days, supporting potential once-weekly oral dosing.

- Placebo-adjusted reduction in PASI score reached 65.9% in mild-to-moderate plaque psoriasis patients 15 days after last dose (28th dose), which supports potential once-weekly oral dosing.

- Strong target engagement after 28-day dosing, indicated by elevated plasma interleukin-17A (IL-17A) levels.

- Once-daily 200 mg 28-day treatment was safe and well tolerated with only mild adverse events observed. No alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations were observed. No hepatic safety signal was detected.

HONG KONG, Sept. 28, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces positive results from a randomized, double-blind, placebo-controlled 28-day proof-of-concept clinical trial with ASC50 in mild-to-moderate plaque psoriasis patients in the U.S. The objectives of the Phase I study were to evaluate the safety, efficacy and pharmacokinetics of once-daily 200 mg of ASC50 after 28-day treatment in mild-to-moderate plaque psoriasis patients (NCT07024602).

Key Findings

• Achieved a placebo-adjusted reduction of 48.9% in psoriasis area and severity index (PASI) score in mild-to-moderate plaque psoriasis patients after once-daily 200 mg 28-day treatment.
• Steady-state elimination half-life after 28-day treatment in patients was 6.5 days, supporting potential once-weekly oral dosing.
• The placebo-adjusted reduction in PASI score increased to 60.7% and 65.9% 6 days and 15 days, respectively, after the last dose (28th dose). These data support potential once-weekly oral dosing.
• 200 mg once-daily dosing demonstrated comparable reduction in PASI score to published secukinumab data (not head-to-head study). Secukinumab is the marketed interleukin-17A (IL-17A) antibody drug.
• Strong target engagement after 28-day dosing, indicated by elevated plasma IL-17A levels.
• Once-daily 200 mg 28-day treatment was safe and well tolerated. All adverse events (AEs) were mild (Grade 1) and transient. No serious adverse events (SAEs) were reported. There was no discontinuation in the study. No alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations were observed. No hepatic safety signal was detected.

"Strong efficacy and encouraging safety and pharmacokinetic data from this proof-of-concept clinical trial support ASC50's potential to be a first-in-class and best-in-class oral small molecule IL-17A inhibitor, offering patients a needle-free administration option to injectable antibody therapies. ASC50's novel scaffold exhibited a steady-state elimination half-life of 6.5 days in patients, supporting the potential for once-weekly oral dosing," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "ASC50 has the potential to be a differentiated oral alternative compared to injectable antibody therapies and will benefit patients with once-weekly oral dosing."

ASC50 is an in-house discovered and developed oral small molecule inhibitor targeting IL-17A, an important biologically and commercially validated target for multiple autoimmune and inflammatory diseases, including psoriasis. ASC50 is a new chemical entity (NCE) with a novel scaffold.

About Ascletis Pharma Inc.

Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potentially best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a once-daily oral small molecule GLP-1R agonist for chronic weight management and diabetes; ASC30_48FDC, a once-daily oral small molecule dual agonist, a fixed dose combination of ASC30 (GLP-1R agonist) and ASC48 (GIPR agonist), ASC30_48_39FDC, a once-daily oral small molecule triple agonist, a fixed dose combination of ASC30 (GLP-1R agonist), ASC48 (GIPR agonist) and ASC39 (amylin receptor agonist (SARA)), ASC39, an eloralintide-like potent selective amylin receptor agonist (SARA) once-daily oral small molecule, ASC30_39FDC, a once-daily oral small molecule dual agonist, a fixed dose combination of ASC30 (GLP-1R agonist) and ASC39 (amylin receptor agonist (SARA)), ASC36, an amylin peptide, designed to be administered once monthly to once quarterly subcutaneously and once daily orally, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist, ASC36_35FDC, a once-monthly subcutaneous triple peptide agonist, a fixed combination of ASC36 (amylin receptor agonist) and ASC35 (GLP-1R/GIPR agonist), ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist, designed to be administered once monthly subcutaneously and once daily orally, and ASC36_37FDC, a once-monthly subcutaneous quadruple peptide agonist, a fixed dose combination of ASC36 (amylin receptor agonist) and ASC37 (GLP-1R/GIPR/GCGR agonist), for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).

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

Contact:
Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
[email protected] 

Ascletis Pharma Inc. PR and IR Teams
+86-181-0650-9129 (China)
[email protected]
[email protected] 

SOURCE Ascletis Pharma Inc.