(AOF) – AB Science has made the decision to stop the inclusion of new patients as well as the initiation of treatment in its clinical studies worldwide with masitinib. This decision follows discussions with the French regulatory authorities (ANSM) and other regulatory agencies. This decision concerns phase 3 in mastocytosis (AB15003), phase 3 in amyotrophic lateral sclerosis (AB19001) and phase 2 in Covid (AB20001).
To do this, AB Science has filed or will submit without delay a request for temporary discontinuation of the study in all the countries concerned by these studies.
AB Science has identified a potential risk of ischemic heart disease with masitinib. This signal was detected in a retrospective analysis of controlled and blinded studies of masitinib.
Following its own internal procedures, AB Science has decided to discontinue ongoing studies with masitinib until the investigation of this possible safety issue is completed. AB Science works closely with the ANSM and other regulatory agencies to carry out the necessary additional analyzes.
Biotech recalled that patient safety is its priority. AB Science is committed to continuing the development of masitinib in the indications initiated, while ensuring patient safety. AB Science is working in full collaboration with the regulatory authorities in order to resume the inclusions in these studies.
Clinical trials (Phases I, II, III)
Phase I: testing of the molecule on a small scale in humans to assess its safety, tolerance, metabolic and pharmacological properties.
Phase II: safety and efficacy evaluation on several hundred patients to identify side effects.
Phase III: evaluation of the overall benefit / risk ratio in several thousand patients.
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Excellent prospects for the sector
According to Moody’s, the turnover of the sector should increase by 4 to 6% in 2021, against 2 to 4% initially forecast.
The top five vaccine manufacturers (Pfizer-BioNTech, Moderna, AstraZeneca, Novavax and Johnson & Johnson) should benefit greatly from this growth, even if there are uncertainties about production capacities. Treatment manufacturers (Gilead, Eli Lilly and Regeneron in particular) should not be left out.
Alongside the opportunities there are also threats, one of which is potential price reductions, in particular in the United States, the world’s largest market. The rise of biosimilars (generics of biological drugs) should also help pull prices down.