诺诚健华TYK2抑制剂ICP-488银屑病III期注册研究达到主要终点

InnoCare Pharma announced Monday that its oral tyrosine kinase 2 (TYK2) inhibitor fadeucravacitinib met the primary endpoint in a phase 3 trial of adults with moderate-to-severe plaque psoriasis.
The study demonstrated that fadeucravacitinib, also known as ICP-488, produced a clinically meaningful improvement, while multiple secondary endpoints were also met, according to the release. InnoCare said the drug demonstrated a favorable safety profile but did not disclose detailed efficacy or safety data.
The randomized, double-blind phase 3 study evaluated the safety and efficacy of fadeucravacitinib compared with placebo in Chinese adults with moderate-to-severe plaque psoriasis.
In October 2024, the Beijing-based biopharmaceutical company reported positive phase 2 results, with 77.3% and 78.6% of patients in two dose groups achieving at least a 75% improvement on the Psoriasis Area and Severity Index at week 12, compared with 11.6% of patients who received placebo. The response rates were in the range of results previously reported for Bristol Myers Squibb’s approved oral TYK2 inhibitor Sotyktu, although the drugs have not been compared in a head-to-head trial.
Moderate-to-severe plaque psoriasis is a chronic, immune-mediated condition characterized by plaques on the skin. Globally, psoriasis affects 125 million people, including approximately 8.66 million people in China, according to the release.
“Existing treatment options do not fully address the needs of psoriasis patients and there is a particularly high demand for novel oral therapies,” InnoCare CEO and co-founder Jasmine Cui, Ph.D., said in the release. “We will work to complete the Phase III study and plan to advance the regulatory filing to bring better treatment options to patients with psoriasis and other autoimmune diseases.”
Fadeucravacitinib is an oral, potent and selective TYK2 inhibitor that blocks signaling by inflammatory cytokines including IL-23, IL-12 and type 1 interferon. The drug targets the same signaling pathway as Takeda’s zasocitinib and BMS’ Sotyktu. Takeda recently reported that zasocitinib beat Sotyktu’s active ingredient, deucravacitinib, across the primary and key secondary endpoints of a head-to-head phase 3 trial.
Takeda has also reported secondary endpoint results from two other late-stage studies of patients with moderate-to-severe plaque psoriasis, including measures of clearance in hard-to-treat areas such as the scalp, palms and soles of the feet. The trials compared zasocitinib with placebo and Amgen’s Otezla. In the two studies, 42% and 30% of patients treated with zasocitinib achieved clear or almost clear skin in certain hard-to-treat areas by week 16.
InnoCare plans to complete the ongoing phase 3 study, including its long-term safety follow-up, before advancing a regulatory filing. Detailed efficacy and safety data are expected to be published or presented at an upcoming scientific meeting.