Press Release Details
Kiniksa Announces Breakthrough Therapy Designation Granted to Vixarelimab for the Treatment of Pruritus Associated with Prurigo Nodularis
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
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 Designation
The 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 demonstrate substantial improvement over available therapies on a clinically significant endpoint.
About Vixarelimab Phase 2a Trial in Prurigo Nodularis
The Phase 2a trial was a randomized, double-blind, placebo-controlled study designed to investigate the efficacy, safety, tolerability, and pharmacokinetics of vixarelimab in reducing pruritus in subjects with prurigo nodularis. The trial enrolled patients with moderate-to-severe prurigo nodularis experiencing moderate-to-severe pruritus (WI-NRS ≥ 7 at the screening visit and a mean weekly WI-NRS of ≥ 5 for each of the two consecutive weeks immediately prior to randomization). Patients were required to stop antihistamines and topical treatments, including corticosteroids, for at least two weeks prior to dosing. Prurigo nodularis treatments, other than study drug, were not allowed except for rescue. For more information, refer to ClinicalTrials.gov Identifier: NCT03816891.
Vixarelimab is an investigational fully-human monoclonal antibody that targets OSMRβ, which mediates signaling of interleukin-31 (IL-31) and oncostatin M (OSM), two key cytokines implicated in pruritus, inflammation and fibrosis. Kiniksa believes vixarelimab to be the only monoclonal antibody in development that targets both pathways simultaneously. Kiniksa’s lead indication for vixarelimab is prurigo nodularis, a chronic inflammatory skin condition characterized by severely pruritic skin nodules. The FDA granted Breakthrough Therapy designation to vixarelimab for the treatment of pruritus associated with prurigo nodularis in 2020.
Kiniksa is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s product candidates, rilonacept, mavrilimumab, vixarelimab and KPL-404, are based on strong biologic rationale or validated mechanisms, target underserved conditions and offer the potential for differentiation. These pipeline assets are designed to modulate immunological pathways across a spectrum of diseases. For more information, please visit www.kiniksa.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our beliefs about research, pre-clinical and clinical trial data demonstrating encouraging results; our beliefs about the potential to positively impact the lives of patients with prurigo nodularis and the importance for such patients of vixarelimab having been granted Breakthrough Therapy designation for the treatment of prurigo nodularis; planned clinical trials and timing thereof, including a potential dose-ranging Phase 2b clinical trial of vixarelimab in prurigo nodularis; and our beliefs about the mechanisms of action of our product candidates and potential impact of their approach.
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Source: Kiniksa Pharmaceuticals, Ltd.