InnoCare Pharma said its TYK2 inhibitor soficitinib met the primary endpoint in the phase 2 portion of a trial in people with nonsegmental vitiligo, allowing the biotech to move into the phase 3 stage of the study.
The 24-week trial, conducted at sites in China, measured changes in the Facial Vitiligo Area Scoring Index, or F-VASI. Patients receiving the higher soficitinib dose recorded a 41.2% change from baseline, compared with 38.8% for the lower dose and 2.2% for placebo. Both doses performed significantly better than placebo, according to the company’s topline results.
Vitiligo is an autoimmune skin disorder in which areas of skin lose pigment. The result places InnoCare in a competitive market. Incyte’s Opzelura is already approved by the U.S. Food and Drug Administration for vitiligo, while Takeda is testing its own TYK2 inhibitor, zasocitinib, in a phase 2 trial.
InnoCare said the treatment was well tolerated and that no new safety signals emerged. But the company has not released detailed safety data or additional efficacy results. It said those findings will be presented at a scientific congress or published in an academic journal.
The drug, also called ICP-332, is under study in several other inflammatory skin conditions, including atopic dermatitis, chronic spontaneous urticaria, plaque psoriasis and prurigo nodularis.
The phase 2 result is encouraging, but it is not approval. The ongoing phase 3 portion will be pivotal in establishing the drug’s benefit-risk profile and its commercial position in vitiligo.