InnoCare Pharma announced promising Phase II clinical trial results for ICP-488, its selective oral TYK2 inhibitor, in the treatment of moderate-to-severe plaque psoriasis. The data was presented as a late-breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting held in Orlando, Florida.
The randomized, double-blinded, placebo-controlled Phase II study enrolled 129 patients with moderate-to-severe plaque psoriasis who received once-daily oral doses of either ICP-488 at 6 mg, 9 mg, or placebo for twelve weeks.
Significant Efficacy Results
The trial met its primary endpoint with statistically significant results. At week 12, 77.3% of patients in the 6 mg daily dose group and 78.6% in the 9 mg daily dose group achieved at least a 75% improvement from baseline in the Psoriasis Area and Severity Index score (PASI 75), compared to just 11.6% in the placebo group (P<0.0001).
Secondary endpoints also showed impressive results. The percentage of patients achieving PASI 90 (at least 90% improvement) reached 36.4% in the 6 mg group and 50.0% in the 9 mg group, while none of the placebo patients achieved this milestone. Additionally, 70.5% of patients in the 6 mg group and 71.4% in the 9 mg group achieved a static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear), compared to only 9.3% in the placebo group.
Safety and Tolerability Profile
The safety data from the trial was equally encouraging. All treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) were classified as mild or moderate, with no serious safety concerns identified. This favorable safety profile, combined with the once-daily oral administration, positions ICP-488 as a potentially convenient and well-tolerated treatment option for psoriasis patients.
Disease Context and Unmet Needs
Psoriasis is a chronic, recurrent, inflammatory, and immune-mediated systemic disease influenced by genetic and environmental factors. It affects approximately 125 million people worldwide and can significantly impact patients' quality of life through physical discomfort, psychological distress, and social stigma.
Current treatment options for moderate-to-severe psoriasis include topical therapies, phototherapy, conventional systemic agents, and biologics. However, many existing treatments come with limitations such as inconvenient administration, safety concerns, or diminishing efficacy over time, creating a need for new oral therapies with improved safety and efficacy profiles.
TYK2 Inhibition: A Promising Approach
TYK2 (Tyrosine Kinase 2) is a member of the Janus kinase (JAK) family that plays a crucial role in immune and inflammatory responses. By selectively inhibiting TYK2, ICP-488 targets key pathways involved in psoriasis pathogenesis while potentially avoiding some of the safety concerns associated with broader JAK inhibition.
Dr. Jasmine Zhu, Chief Medical Officer of InnoCare, commented on the results: "These Phase II data demonstrate that ICP-488 has the potential to become a best-in-class treatment option for patients with moderate-to-severe plaque psoriasis. The high response rates at both doses, combined with the favorable safety profile, support our confidence in advancing this program."
Company Background and Market Position
InnoCare Pharma is a commercial-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases. The company has established a global presence with branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
The positive results for ICP-488 could strengthen InnoCare's position in the competitive autoimmune disease market. The company's stock has shown strong performance this year with a year-to-date price increase of 59.31%, suggesting investor confidence in its pipeline and commercial prospects.
Next Steps in Development
Following these positive Phase II results, InnoCare is expected to advance ICP-488 into Phase III clinical trials. The company will likely engage with regulatory authorities to discuss the path forward for potential approval.
"We are excited by the potential of ICP-488 to address the significant unmet needs that remain in psoriasis treatment," said Dr. Jasmine Zhu. "We look forward to continuing the development of this promising therapy and bringing it one step closer to patients who could benefit from it."
The presentation of these results at the prestigious AAD Annual Meeting, one of the most influential international events in dermatology, highlights the scientific community's interest in this novel approach to psoriasis treatment.
