Sanofi To Halt Clinical Trials Of JAK2 Inhibitor Fedratinib

(RTTNews) - French drug maker Sanofi SA (SNYNF.PK, SNY) said Monday that it has decided to halt all clinical trials and also cancel plans for regulatory filings with its investigational JAK2 inhibitor, fedratinib or SAR302503. Fedratinib is an inhibitor for certain types of cancer.

Sanofi said that after a thorough risk-benefit analysis, including consultation with the U.S. Food and Drug Administration or FDA, it determined that the risk to patient safety outweighed the benefit that fedratinib would bring to patients.

Fedratinib is a novel, investigational JAK2 inhibitor that was under development by Sanofi Oncology for the treatment of the three main types of myeloproliferative neoplasms - primary myelofibrosis, including those previously treated with ruxolitinib; polycythemia vera; and essential thrombocythemia.

According to Sanofi, the decision to discontinue development of fedratinib was taken following reports of patients participating in fedratinib clinical trials began to develop cases consistent with Wernicke's encephalopathy in patients participating in fedratinib clinical trials.

The FDA directed Sanofi to put all fedratinib trials on clinical hold, while the company thoroughly investigated these cases to ensure the safety of fedratinib for patients. Sanofi said it took immediate action requesting that study investigators discontinue fedratinib treatment for patients in the trials.

Tal Zaks, Head of Development and Interim Head of Sanofi Oncology, said, "We are deeply disappointed to have to discontinue development of fedratinib, especially given the needs of this difficult-to-treat patient population and the earlier promise shown for this therapy, but patient safety is our top priority and drove this decision."

Sanofi said it has notified investigators of all ongoing fedratinib trials, as well as health authorities, of its decision to halt the trials. Patients currently in fedratinib trials should consult with their treating physician to determine the best alternative course of therapy for their myelofibrosis.

In late October, Sanofi reported a lower profit for the third quarter, hit by vaccines shortage in the U.S., market slowdown in China and troubles to the generics business in Brazil. Net income attributable to equity holders of Sanofi declined to 1.213 billion euros or $1.67 billion from 1.539 billion euros in the previous year. Net sales declined 7 percent to 8.43 billion euros from 9.04 billion euros in the prior year.

In Paris, Sanofi's shares are currently trading at 80.21 euros, up 0.30 euros or 0.38 percent on a volume of 774,863 shares.