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AB Science Announces Positive Top-Line Results from Phase 3 Trial of Masitinib in Adults with Severe Systemic Mastocytosis | ||
By: Nasdaq / GlobeNewswire - 30 Nov 2015 | Back to overview list |
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Paris, 30 November 2015, 6.15pm
AB Science Announces Positive Top-Line Results
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), today announced that that a phase 3 study evaluating masitinib in the treatment of adult patient with severe systemic mastocytosis has met its primary objective well as all its secondary objectives Top-line results will be detailed in the coming days. About the phase 3 study in severe systemic mastocytosis The phase 3 study was designed to evaluate masitinib efficacy and safety in severe systemic mastocytosis patients, with or without D816V mutation of c-Kit. The primary objective of the phase 3 study was to detect a statistically significant difference between masitinib (plus concomitant symptomatic treatments) and placebo (plus concomitant symptomatic treatments) in cumulative response on four severe symptoms, referred to also as handicaps. Patients enrolled in the phase 3 study had between one and four of the following severe mastocytosis-related symptoms at baseline:
The study enrolled 135 patients with severe systemic mastocytosis. Primary objective: Primary analysis (referred to as "4H75% response") was based on the comparison between masitinib and placebo in the number of actual responses between week 8 and week 24 divided by the total number of possible responses over the same treatment period. At each patient evaluation between weeks 8 and 24, each of the above four severe symptoms was evaluated. An improvement > 75% with respect to baseline in one symptom represented one positive treatment response. Secondary objectives: Secondary analyses were based on the following endpoints:
The symptoms of pruritus and flush are well-recognized to be associated with mast cell activation in mastocytosis.
Targeted population with masitinib in mastocytosis Mastocytosis is an orphan disease characterized by an abnormal proliferation or activation of mast cells either in the skin or in bone marrow or other organs. Mastocytosis comes in two main forms: indolent and aggressive. Indolent forms of mastocytosis can be either cutaneous or systemic. The prevalence of indolent systemic mastocytosis, including smoldering systemic mastocytosis, is estimated to be 1/26,000 in Europe 1 . The symptoms and handicaps are severe in about one third of the patients; hence, an estimated target population for masitinib of approximately 1/78,000 of the general population. Since the prevalence of indolent forms of systemic mastocytosis is reputed to be comparable across countries, the target population for masitinib could reach 10,000 adult patients in the USA and in Europe. 1: Prevalence of rare diseases: Bibliographic data, Orphanet Report Series, Rare Diseases collection, July 2015, Number 1: Listed in alphabetical order of disease or group of diseases. http://www.orpha.net/orphacom/cahiers/docs/GB/Prevalence_of_rare_diseases_by_alphabetical_list.pdf Orphan Drug Status
Masitinib has been granted orphan drug status in mastocytosis by both FDA and EMA.
About masitinib
About AB Science
Further information is available on AB Science website: http://www.ab-science.com This document contains prospective information. No guarantee can be given as for the realization of these forecasts, which are subject to those risks described in documents deposited by the Company to the Authority of the financial markets, including trends of the economic conjuncture, the financial markets and the markets on which AB Science is present. * * *
AB Science - Financial Communication & Media Relations
This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein. Source: AB Science via GlobeNewswire
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