AB Science expects “Gradually resume” from September the trials of its flagship molecule in the treatment of amyotrophic lateral sclerosis (ALS), announced Monday the French biotech, which received a first authorization from a national health agency.
Read alsoCovid-19: AB Science obtains 15 million euros for its research on masitinib
The company had to suspend its main clinical trials of masitinib in June, after identifying a risk of “ischemic heart disease” in patients taking the treatment. On Monday, she announced that she had received a first authorization from the Norwegian agency for the resumption of trials in the phase 3 study for Charcot’s disease. This authorization follows his presentation of a new risk management plan to strengthen cardiac safety, explains a press release.
ANSM validation
Already in July, AB science announced that the National Medicines Safety Agency (ANSM) in France was validating this new risk management program, “Allowing to consider the resumption of inclusions in its three ongoing studies, namely phase 3 in mastocytosis, phase 3 in amyotrophic lateral sclerosis and phase 2 in Covid”. “AB Science anticipates being able to gradually resume inclusions at the global level during the month of September”, specifies the company Monday.
In June, its listing on the Paris Bourse had fallen by more than 30%, AB Science having bet everything on masitinib, a molecule that blocks the functioning of a cell suspected of playing the role of control tower of the immune system. The group is counting on it to provide a response to a wide range of diseases including cancers, Charcot disease and Covid-19.
– .
