Source: Benzinga

AB Science: AB Science granted authorization to initiate phase 3 confirmatory study of masitinib in indolent systemic mastocytosis

Paris, October 24, 2019, 7pmAB Science granted authorization to initiate phase 3 confirmatory study of masitinib in indolent systemic mastocytosis Company to host live webcast on November 20, 2019 on indolent systemicmastocytosis with Key Opinion LeadersAB Science SA (NYSE Euronext - FR0010557264 - AB) today announces that it has been authorized by the French Medicine Agency, ANSM, to initiate the Phase 3 confirmatory study evaluating masitinib in indolent systemic mastocytosis.This study (AB15003) is a multicenter, randomized, double blind, placebo-controlled, phase 3 study to compare the efficacy and safety of masitinib dose titration up to 6 mg/kg/day with that of placebo in treatment of patients with severe indolent systemic mastocytosis, unresponsive to optimal symptomatic treatment.The study is designed to enroll 140 patients with or without the D816V mutation of c-Kit. The primary endpoint is a measure of the cumulative response on 3 severe symptoms of mast cell mediator release (pruritus, flush and depression) from week 8 to week 24. Secondary endpoints will measure response on the severe symptoms of pruritus, flushes, depression, and fatigue, taken together and individually, quality of life, as well as biological (tryptase) and skin involvement parameters. Under this protocol, severe symptoms of mast cell mediator release (also referred to as handicaps) are defined as: pruritus (score ≥ 9), flush (score ≥ 8), depression (HAMD-17 ≥ 19), and fatigue (FIS ≥ 75 or FSS ≥ 36).Alain Moussy, CEO and co-founder of AB Science said "We are committed to bring masitinib as a first therapeutic option for patients suffering from indolent systemic mastocytosis, and we are extremely pleased with this authorization to initiate phase 3, which is a key step in the development program of masitinib in this indication"."Results from our prior phase 3 study, which enrolled 135 patients and was published in The Lancet, showed that masitinib can substantially reduce severe symptoms associated with indolent systemic mastocytosis, regardless of a patient's c-Kit mutational status," said Professor Olivier Hermine M.D., President of the Scientific Committee of AB Science and coordinator of the Reference Center for Mastocytosis (CeReMast, Paris, France). "Moreover, both efficacy and safety data indicate a possibility for the effective long-term management of this difficult-to-treat condition with masitinib. This observation is important, given that indolent systemic mastocytosis is a chronic condition ...Full story available on Benzinga.com

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