The National Agency for Drug Safety (ANSM) announced Thursday the suspension of clinical trials conducted by the pharmaceutical company AB science for its flagship molecule, Masitinib.
The ANSM criticizes AB Science for not having complied with its obligations towards the authorities concerning the tests but also for undesirable tests that "the risks incurred by the patients are out of proportion to the expected benefit for them. ", Says the Agency in its decision published on its website.
"Lack of reliability of efficacy data", "lack of control", "failures in terms of good clinical practice", the reasons given by the Agency to justify its decision are numerous.
"As a result, clinical trials in progress will not be able to prove the benefit of the experimental drug for the patients participating in the research," believes the ANSM.
Contacted by AFP, AB Science was not available Thursday evening to comment on the decision of the ANSM.
Founded in 2001, AB Science has developed its lead molecule, Masitinib, which is an inhibitor of tyrosine kinase, an enzyme that plays a key role in the activation and inhibition of many cellular functions.
The molecule was tested for a dozen indications, including cancers, neurological and inflammatory diseases such as multiple sclerosis and Charcot's disease.
The company had announced the 31 March have raised 19 million, from European and US funds, to fund its clinical development program until late 2019.
Last August, the Masitinib received the designation "orphan drug" in the European Union, a statute intended to facilitate the development of remedies for rare diseases.
The molecule was obtained just before the same designation from the Food and Drug Administration (FDA).