Kiniksa Announces Breakthrough Therapy Designation Granted to Vixarelimab for the Treatment of Pruritus Associated with Prurigo Nodularis

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[{"type":"text","content":"HAMILTON, Bermuda, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to vixarelimab for the treatment of pruritus associated with prurigo nodularis, a chronic inflammatory skin condition characterized by severely pruritic skin nodules. Vixarelimab is a fully-human monoclonal antibody that targets oncostatin M receptor beta (OSMRβ).\n Kiniksa’s Breakthrough Therapy application was based on data from the Phase 2a clinical trial of vixarelimab in prurigo nodularis. The Phase 2a trial met its primary efficacy endpoint: there was a statistically significant reduction in weekly-average Worst-Itch Numeric Rating Scale (WI-NRS) from baseline at Week 8 in vixarelimab recipients compared to placebo recipients. Additionally, the majority of vixarelimab recipients showed a clinically meaningful greater-than-or-equal-to 4-point weekly-average WI-NRS reduction at Week 8, and a statistically significant percentage of vixarelimab recipients achieved a prurigo nodularis-investigator’s global assessment (PN-IGA) score of 0/1 at Week 8 compared to placebo recipients. “The FDA granting Breakthrough Therapy designation to vixarelimab for the treatment of pruritus associated with prurigo nodularis is an important step forward for patients,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “The Phase 2a study of vixarelimab in prurigo nodularis demonstrated encouraging results in both pruritus and nodule response. We believe vixarelimab has the potential to positively impact the lives of those suffering from prurigo nodularis, a devastating disease for which there are no FDA-approved therapies.” Kiniksa expects to initiate a Phase 2b clinical trial of vixarelimab in prurigo nodularis, evaluating a range of once-monthly dose regimens, by the end of the year. About Breakthrough Therapy DesignationThe FDA defines Breakthrough Therapy designation as a process designed to expedite the development and review of drug candidates that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug candidate may demonstr...

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