Accro Bioscience (Suzhou) Limited, operating under the brand name Accropeutics, has announced highly encouraging results from its Phase 2 clinical trial of AC-201, a novel oral small-molecule drug targeting autoimmune skin disorders. The drug is designed to selectively inhibit TYK2 and JAK1 pathways—key drivers of inflammatory diseases such as plaque psoriasis.
This development marks a significant step in Accropeutics’ mission to provide safer and more effective therapies for immune-mediated diseases. With a growing global demand for advanced psoriasis treatments, the success of AC-201’s clinical results may place the company in a strong position within the dermatology and immunology space.
Trial Overview: Scope, Methodology, and Patient Base
The Phase 2 trial was conducted as a multicenter, randomized, double-blind, placebo-controlled study. It enrolled 145 adult Chinese patients diagnosed with moderate-to-severe plaque psoriasis.
Participants were randomly assigned to four treatment groups:
- 25 mg of AC-201 twice daily (BID)
- 50 mg BID
- 100 mg once daily (QD)
- Placebo
The treatment duration was 12 weeks, and the primary endpoint was achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI-75).
Key Results: AC-201 Delivers Strong Efficacy
The trial met its primary endpoint with statistically significant results:
- Placebo group: 8.1% PASI-75
- 25 mg BID: 31.4% PASI-75 (P=0.012 vs. placebo)
- 50 mg BID: 74.3% PASI-75 (P<0.001 vs. placebo)
- 100 mg QD: 59.5% PASI-75 (P<0.001 vs. placebo)
Secondary endpoints were also promising. High response rates were observed in PASI-90 and static Physician’s Global Assessment (sPGA) 0/1 categories across all dosing groups, confirming the drug’s robust therapeutic potential.
Safety Profile: Well-Tolerated With Minimal Side Effects
AC-201 was reported to be well-tolerated, with no serious adverse events during the trial. The most frequently observed side effects included:
- Mild to moderate upper respiratory tract infections
- Hypertriglyceridemia (elevated triglyceride levels)
These findings align with Phase 1 trial results conducted in Australia and China, where the drug exhibited dose-proportional pharmacokinetics and low drug accumulation over multiple doses.
Mechanism of Action: Targeting TYK2/JAK1 Without JAK2 Impact
What sets AC-201 apart is its unique mechanism. It selectively inhibits the pseudo-kinase domain (JH2) of the TYK2 and JAK1 pathways without significantly affecting JAK2, which is essential for maintaining hematopoietic function. This targeted action helps reduce inflammatory cytokines—a major contributor to autoimmune flare-ups—while minimizing hematological side effects.
Strategic Outlook: More Than Just Psoriasis
According to Dr. Xiaohu Zhang, co-founder and CEO of Accropeutics, the company plans to accelerate the clinical development of AC-201. Beyond psoriasis, the drug is also being investigated for conditions like systemic lupus erythematosus (SLE) and other immune-mediated inflammatory diseases.
With increasing attention on safer, oral biologic alternatives, AC-201 has the potential to compete with injectable biologics, offering both convenience and cost-efficiency.
Conclusion: A Promising Future for Oral Immunomodulators
The positive results from the Accropeutics AC-201 Phase 2 trial indicate a promising future for oral small-molecule immunomodulators in dermatology and beyond. If subsequent trials confirm these findings, AC-201 could become a first-line oral therapy for moderate-to-severe psoriasis, offering an alternative to injectables and corticosteroids.
As Accropeutics gears up for Phase 3 trials, the global medical community will be watching closely for further developments.
