2023-03-20 08:07:19 ET
Incyte ( NASDAQ: INCY ) shares traded ~5% higher on Monday after announcing that its oral JAK1 inhibitor povorcitinib met the primary endpoint in a Phase 2b clinical trial for adults with vitiligo, a chronic autoimmune disease characterized by skin depigmentation.
The randomized, double-blind study involved 171 patients who indicated nonsegmental vitiligo over ?8% of their body surface area and received once-daily povorcitinib across three dose levels or placebo for 24 weeks.
Its primary endpoint was the percentage change in total body Vitiligo Area Scoring Index (T-VASI) at Week 24 from baseline. A key secondary endpoint was the percentage of patients achieving a?50% reduction in the T-VASI at Week 24 from baseline.
The study met the primary endpoint as povorcitinib-treated patients experienced statistically superior improvements of T-VASI at Week 24 compared to placebo across 15 mg, 45 mg, and 75 mg doses.
A higher number of povorcitinib-treated patients also reached the key secondary endpoint of T-VASI50 at Week 24 and continued to benefit from the therapy during an open-label extension period through Week 36.
COVID-19 (16.7%), headache (10.3%), and fatigue (9.5%) were among the most frequently cited treatment-emergent adverse events (TEAEs) during the 24-week placebo-controlled period. There were no serious TEAEs linked to povorcitinib.
Read: Seeking Alpha contributor Denis Buivolov lowered his Strong Buy rating on Incyte ( INCY ) to Buy in January, citing loss of exclusivity for its key product Jakafi.
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Incyte says mid-stage trial for vitiligo therapy met main goal