Skip to main content

When you're trying to reclaim lost credibility and prove to investors that the phase III study results you've touted for months are real, having regulators in your home country suspend clinical trials due to sloppy conduct and safety concerns is not helpful.

This is the unsettling situation facing French drug maker AB Science. On Thursday, the Agence Nationale de la Securite des Medicaments (ANSM) ordered a halt to all clinical trials in France of AB Science's lead drug masitinib.

Shares of AB Science were halted Friday on the Euronext Paris exchange.

The order resulted from an inspection by ANSM regulators that uncovered multiple violations by AB Sciences of the rules and procedures governing the conduct of masitinib clinical trials. ANSM said the reliability of efficacy and safety data from the AB Science clinical trials was in doubt. Patients enrolled in AB Science clinical trials were put at extra risk because toxicities related to masitinib were not fully disclosed.

Scroll to Continue

TheStreet Recommends

AB Science issued a statement Friday acknowledging the ANSM ruling but insisted the violations of masitinib clinical trial procedures occurred between 2009 and 2015, before the company installed more robust quality control procedures.

Inspections and audits of clinical trials after 2015 have not revealed any problems, AB Science said. The newly clean sheet extends to the phase III study of masitinib in amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, AB Science said.

The company said last February that masitinib achieved the primary endpoint in the ALS study but detailed data have not yet been shared publicly. Researchers are presenting the masitinib ALS data on May 18.

AB Science already suffers from a credibility problem because of previous failures related to masitinib's clinical development. European regulators have rejected the drug twice already, turning away applications to treat two types of cancer, GIST and pancreatic.

You can read the ANSM ruling (in French) here. The full statement from AB Science responding to the ANSM ruling can be read here

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.