This morning, Hamilton, Bermuda based biopharmaceutical company Kiniksa Pharmaceuticals Ltd. (KNSA:NASDAQ), which is focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical needs, announced that "the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for rilonacept for the treatment of recurrent pericarditis."
The report indicated that "Kiniksa's Breakthrough Therapy application was based on final data from an open-label Phase 2 clinical trial of rilonacept in a range of pericarditis populations that were included in a poster presentation at the American Heart Association Scientific Sessions on November 16, 2019."
The firm explained that 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."
The company identifies Rilonacept as "a weekly, subcutaneously-injected, recombinant fusion protein that blocks inflammatory cytokines interleukin-1α (IL-1α) and interleukin 1β (IL-1β) signaling." Rilonacept in recurrent pericarditis is at present still classified as an investigational drug.
Kiniksa exclusively licensed rilonacept from Regeneron Pharmaceuticals Inc. for recurrent pericarditis and certain other indications. The company noted that "rilonacept was discovered and developed by Regeneron and is approved by the FDA under the brand name ARCALYST for the treatment of Cryopyrin-Associated Periodic Syndromes, which includes Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome."
Kiniksa's CEO and Chairman Sanj K. Patel commented, "We are pleased that the FDA has granted Breakthrough Therapy designation for rilonacept for the treatment of recurrent pericarditis, a painful and debilitating autoinflammatory cardiovascular disease...The final Phase 2 data presented at AHA showed rilonacept treatment improved clinically meaningful outcomes associated with unmet need in recurrent pericarditis, including rapid resolution of pericarditis episodes, tapering and discontinuation of corticosteroids without pericarditis recurrence, reduction in recurrences of pericarditis episodes while on treatment, and improvement in quality of life scores. We continue to enroll RHAPSODY, our pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis, and expect top-line data in the second half of 2020."
The company describes the RHAPSODY study, which is taking place in the U.S., Australia, Israel and Italy, as an ongoing, global, randomized withdrawal (RW) design, pivotal Phase 3 clinical trial of rilonacept in patients with recurrent pericarditis. The firm advised that the study's co-principal investigators are Dr. Allan Klein of Cleveland Clinic and Dr. Massimo Imazio of the University of Torino, Italy, and that top-line data from the study are expected in H2/20.
Kiniksa Pharmaceuticals is headquartered in Hamilton, Bermuda, and is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating autoinflammatory and autoimmune diseases with significant unmet medical need. Kiniksa's pipeline of product candidates across various stages of development include Rilonacept for the potential treatment of recurrent pericarditis; Mavrilimumab for the potential treatment of giant cell arteritis; KPL-716 for the potential treatment of a variety of pruritic diseases, including prurigo nodularis, a chronic inflammatory skin condition; and several others.
Kiniksa has a market capitalization of around $380.9 million with about 58.88 million outstanding shares. KNSA shares opened nearly 30% higher today at $8.98 (+$2.04, +29.34%) over the prior day's closing price of $6.94. The stock has traded today between $8.08 to $9.49 per share and currently is trading at $8.86 (+$1.92, +27.67%).
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