Incyte says under-the-radar JAK inhibitor JAK inhibitor clears a high bar for skin disorder

2023-02-13

临床结果临床3期临床2期

Incyte — the company behind Jakafi and Olumiant — wants to put a third JAK inhibitor JAK inhibitor on the map. Presenting at the European Hidradenitis Suppurativa Foundation conference, the biotech highlighted long-term data from a Phase II trial testing povorcitinib as a treatment for hidradenitis suppurativa (HS)HS), a skin condition characterized by painful nodules and abscesses. If the results hold up in Phase III, the drug may “establish a new high water mark for efficacy,” Cowen analyst Marc Frahm wrote in a note, even as it goes against AbbVie’s Humira and Novartis’ Cosentyx. The drug, which met the primary endpoint at week 16, continued to help patients keep those nodules and abscesses under control during a 36-week open-label extension period, Incyte reported. While patients were previously randomized into four dose groups — placebo, 15 mg, 45 mg and 75 mg — they were all given 75 mg in that extension study. At week 56, Incyte said, 22% to 29% of patients across the cohorts saw all their abscesses and inflammatory nodules go away, with “no increase from baseline in abscess or draining tunnel count.” According to Frahm, povorcitinib offers improved durability and depth of response compared to other drugs, including experimental therapies such as UCB’s IL-17 inhibitor IL-17 inhibitor bimekizumab. “To our knowledge, no other agent for HS HS has reported data for such a high efficacy hurdle,” he wrote, adding that given safety concerns with the JAK class, “clear differentiation will likely be required to counteract the class labeling povorcitinib is likely to receive from the FDA, and maximize the commercial opportunity.” While Incyte’s approved JAK drugs, Jakafi and Eli Lilly-partnered Olumiant, block both JAK1 and JAK2, povorcitinib only hits JAK1. But it’s run into hurdles with another JAK1 program that it once pinned blockbuster hopes on, as itacitinib flunked trials in both acute and chronic graft versus host disease. With HS, the company also highlighted that povorcitinib is an oral option that can be administered for a longer term. “Despite the available treatments for HS HS, no uniformly-effective therapy has been found, underscoring the need for additional options,” said Kurt Brown, Incyte’s global program head for povorcitinib and associate vice president, drug development, inflammation and autoimmunity. A Phase III study began late last year and Incyte expects to see preliminary data in 2025.

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