“The first quarter of 2019 was marked by the advancement of our clinical-stage pipeline,” said Sanj K. Patel, CEO and Chairman of the Board of Kiniksa. “Progress included the initiation of our Phase 2a trial for KPL-716 in prurigo nodularis as well as the continued enrollment of our pivotal Phase 3 trial for rilonacept in recurrent pericarditis and our global Phase 2 trial for mavrilimumab in giant cell arteritis. Going forward, we expect to build upon this momentum with focused investment behind our product candidates, including commercial readiness activities for rilonacept, and continued execution.” Kiniksa is enrolling RHAPSODY, a global, randomized-withdrawal design, pivotal Phase 3 clinical trial of rilonacept in subjects with recurrent pericarditis. The primary efficacy endpoint is time-to-first-adjudicated pericarditis-recurrence in the RW period. Top-line data are expected in the second half of 2020. Kiniksa is enrolling a global Phase 2 proof-of-concept clinical trial of mavrilimumab in subjects with GCA. The primary efficacy endpoint is time-to-first-flare. Top-line data are expected in the second half of 2020. Kiniksa is enrolling a Phase 2a clinical trial of KPL-716 in subjects with prurigo nodularis. The primary efficacy endpoint is percent change from baseline in weekly average Worst-Itch Numeric Rating Scale. Top-line data are expected in the first half of 2020. Kiniksa plans to initiate an exploratory Phase 2 clinical trial in diseases characterized by chronic pruritus in the first half of 2019. The trial is designed to identify chronic pruritic conditions where interleukin-31 and/or oncostatin M may be playing a role and to investigate the efficacy, safety and tolerability of KPL-716 in reducing the moderate-to-severe pruritus experienced by these subjects. Top-line data are expected in the second half of 2020. Kiniksa is progressing its preclinical activities with KPL-404, a monoclonal antibody inhibitor of the CD40 co-stimulatory receptor, in T-cell-dependent, B-cell-mediated disorders. Kiniksa expects to file an investigational new drug application with the FDA in the second half of 2019 and initiate a Phase 1 clinical trial in the first half of 2020. Kiniksa expects that its cash, cash equivalents and short-investments will fund its current operating plan into 2021.
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