InnoCare’s TYK2 inhibitor fadeucravacitinib (ICP-488) met the primary endpoint in its Phase III psoriasis trial, advancing the drug toward regulatory submission
Executive summary: InnoCare announced that its Phase III clinical study of fadeucravacitinib (ICP‑488) met the primary efficacy endpoint and multiple secondary endpoints in patients with moderate-to-severe plaque psoriasis. Meeting the primary endpoint validates the drug’s mechanism of action and clears a key hurdle for regulatory submission, potentially adding a new treatment option to the psoriasis market.
Who is involved: InnoCare Pharma (HKEX:09969; SSE:688428) sponsored the trial; investigators were global dermatology sites; the drug targets tyrosine kinase 2 (TYK2).
Likely next: InnoCare expects to prepare and submit a New Drug Application to the FDA and a Marketing Authorization Application to the EMA, with filings anticipated in late 2026 and early 2027 respectively.
In a Phase III study, InnoCare’s novel TYK2 inhibitor fadeucravacitinib achieved the primary efficacy endpoint and several secondary endpoints in patients with moderate-to-severe plaque psoriasis. The result positions the candidate to compete with existing TYK2‑targeted therapies such as deucravacitinib. No safety concerns were highlighted in the release, and the company indicated next steps toward filing for approval.
Timeline
- — InnoCare's TYK2 Inhibitor Fadeucravacitinib (ICP-488) Meets Primary Endpoint in Phase III Psoriasis Study (GlobeNewswire)
Analysis — what this means
Sectors affected
- Biopharmaceutical
- Dermatology
Regulatory implications
- InnoCare plans to file an NDA with the FDA in Q4 2026.
- A corresponding MAA is planned for submission to the EMA in early 2027.
Historical parallels
- Deucravacitinib (Sotyktu) received FDA approval for plaque psoriasis in September 2022.
Key entities
Sources
- InnoCare's TYK2 Inhibitor Fadeucravacitinib (ICP-488) Meets Primary Endpoint in Phase III Psoriasis Study — GlobeNewswire
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