AB Science has “received authorization from the National Medicines Safety Agency to initiate a Phase III study […] evaluating masitinib in patients with multiple sclerosis.
French biotech AB Science said Monday it had obtained the green light from the National Medicines Safety Agency (ANSM) to launch trials of its flagship molecule against multiple sclerosis. The company has “received authorization from the ANSM to initiate a Phase III study […] evaluating masitinib in patients with primary progressive multiple sclerosis (PPMS) or non-active secondarily progressive multiple sclerosis (nSPMS), “she said in a statement.
The objective of the study will be to assess the effect of the molecule, which blocks the functioning of a cell suspected of playing the role of control tower of the immune system, “on the time before confirmed progression of the handicap”, continues -she. “To date, there is no treatment capable of effectively targeting cells of the innate immune system which are associated with the pathology of progressive forms of multiple sclerosis. Masitinib selectively targets these cells,” said the professor. Olivier Hermine, president of the scientific committee of AB Science, quoted in the press release.
AB Science had to suspend its main clinical trials of masitinib in June, after identifying a risk of “ischemic heart disease” in patients taking the treatment. This suspension had led to a 30% drop in its listing on the Stock Exchange.
A new risk management program
In July, AB Science announced that the ANSM was validating its new risk management program, strengthening cardiac safety, “making it possible to consider the resumption of inclusions in its three ongoing studies”.
In August, she had received a first authorization to resume trials by the Norwegian health agency, to test the molecule on Charcot’s disease. Then she had received a new authorization from the Food and Drug Administration (FDA), the American health authority, in November to resume the recruitment of patients as part of a study on amyotrophic lateral sclerosis (ALS).
AB Science relies on masitinib to provide a response to a wide range of diseases, including cancers and even Covid-19.
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