InnoCare Pharma’s tyrosine kinase 2 (TYK2) inhibitor has hit the main goals of a phase 2 trial in China, sustaining the biotech’s hopes it can provide a new oral option for patients with psoriasis.
The study saw 129 patients with moderate to severe plaque psoriasis receive either 6-mg or 9-mg daily doses of the drug, dubbed ICP-488, or placebo. A total of 77.3% and 78.6% of patients in the respective dosing groups achieved a 75% improvement in the Psoriasis Area and Severity Score (PASI 75) at Week 12, compared to 11.6% of the placebo cohort.
In addition, 36.4% and 50%, respectively, of the ICP-488 cohorts reached PASI 90 compared to none of the patients who received placebo. It was a similar pattern for PASI 100, which was reached by 11.4% and 11.9% of the ICP-488 cohorts, respectively.
The drug demonstrated a favorable safety profile, with most treatment-related adverse events being mild or moderate, InnoCare added.
While like-for-like comparisons between trials should always be treated with caution, today’s data compare favorably with Bristol Myers Squibb’s approved oral TYK2 inhibitor Sotyktu. In one phase 2 trial, Sotyktu achieved a PASI 75 rate of 67% across 276 patients taking a 6-mg dose twice daily and 75% for patients taking a 12-mg dose daily at 12 weeks.
Takeda’s TAK-279, which it bought from Nimbus Therapeutics for $4 billion, reached a PASI 75 rate of 68% and 67% at the middle and high dose levels, respectively, over the same period.
InnoCare has its eye on the several million people with psoriasis in its home country of China and said current treatment options “do not fully address the needs of those affected by this condition” with a “particularly acute demand for new, oral medications.”
China has a relatively low rate of psoriasis compared to countries like the U.S., but, given its large population, still has one of the largest numbers of adults in one country with the condition in the world.
“Psoriasis requires long-term management, and there remains a significant unmet medical need for new treatments,” InnoCare’s CEO and co-founder Jasmine Cui said in this morning’s release. “We are excited to see the positive results from the phase 2 study of ICP-488, and we will further accelerate its clinical development to benefit patients with psoriasis and other autoimmune diseases.”