AB SCIENCE ANNOUNCES A VOLUNTARY HOLD IN THE CLINICAL STUDIES OF MASITINIB WORLDWIDE
Paris, June 1st, 2021, 7am
AB Science SA (Euronext – FR0010557264 – AB) introduced at present that it has taken the choice to droop inclusions and therapy initiation in its scientific research with masitinib worldwide. This determination follows session with the French regulatory authorities (ANSM) and different regulatory companies. This determination is related to 3 research: section 3 in mastocytosis (AB15003), section 3 in amyotrophic lateral sclerosis (AB19001) and section 2 in COVID (AB20001). To this finish, AB Science has filed or will file at once a request for a brief examine maintain in all international locations the place these research are ongoing.
AB Science has recognized a possible threat of ischemic coronary heart illness with masitinib. This sign was detected in a retrospective evaluation of managed and unblinded research of masitinib. Following its personal inner procedures, AB Science has determined to droop inclusion in ongoing research with masitinib till the investigation of this potential security situation is completed. AB Science is working carefully with the ANSM and different regulatory companies to finish the mandatory extra analyses.
Affected person security is our precedence. AB Science is dedicated to proceed the event of masitinib within the indications initiated, whereas guaranteeing affected person security. AB Science is working in full collaboration with the regulatory authorities so as to resume affected person enrollment in these research.
Masitinib is a brand new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, necessary cells for immunity, by way of inhibiting a restricted variety of kinases. Primarily based on its distinctive mechanism of motion, masitinib could be developed in numerous situations in oncology, in inflammatory ailments, and in sure ailments of the central nervous system. In oncology as a result of its immunotherapy impact, masitinib can affect survival, alone or together with chemotherapy. By way of its exercise on mast cells and microglia and consequently the inhibition of the activation of the inflammatory course of, masitinib can affect the signs related to some inflammatory and central nervous system ailments and the degeneration of those ailments.
About AB Science
Based in 2001, AB Science is a pharmaceutical firm specializing within the analysis, growth and commercialization of protein kinase inhibitors (PKIs), a category of focused proteins whose motion are key in signaling pathways inside cells. Our applications goal solely ailments with excessive unmet medical wants, typically deadly with brief time period survival or uncommon or refractory to earlier line of therapy.
AB Science has developed a proprietary portfolio of molecules and the Firm’s lead compound, masitinib, has already been registered for veterinary drugs and is developed in human drugs in oncology, neurological ailments, inflammatory ailments and viral ailments. The corporate is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).
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