Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi SA (ADR)(NYSE:SNY) have announced that a Phase II clinical trial of the injection treatment Dupixent has met its primary endpoint. The drug is designed to treat adults suffering from eosinophilic esophagitis. Earlier in the year approval was given for Dupixent to be marketed as a treatment for eczema or atopic dermatisis in the U.S. Last month the drug also received approval as a treatment for atopic dermatitis in the European Union.
Patients suffering from eosinophilic esophagitis exhibit symptoms such as swallowing difficulties which are brought about by inflammations. The main cause of the condition is food allergies and some of the recommended methods of treatment currently being used include surgery and corticosteroids. Patients are also required to modify their diets.
Inflammation severity
Data obtained from the trial indicated that patients who received a Dupixent injected on a weekly basis showed signs of improvement with regards to swallowing abilities in comparison to patients who were given a placebo. When treated with the drug on a weekly basis, the level of inflammation severity in the esophagus also reduced.
“Dupilumab, a monoclonal antibody targeting interleukin (IL)-4 and IL-13, significantly improved patients’ ability to swallow, inflammation of the esophagus, and endoscopic signs of the disease. These positive Phase II results support further clinical development of dupilumab for patients with eosinophilic esophagitis,” said Northwestern University Feinberg School of Medicine’s professor of medicine, Ikuo Hirano, in a statement.
Other indications
In the second quarter sales generated by Dupixent reached a figure of 26 million euros following strong demand. Besides eosinophilic esophagitis and atopic dermatitis Dupixent is also undergoing evaluation for the treatment of other inflammatory indications such as nasal polyposis and asthma. In September Regeneron and Sanofi revealed that the drug had met two primary endpoints with regards to an Asthma Phase III trial.
In the trial when Dupixent was added to standard treatments there was a reduction in severe asthma attacks as well as an improvement in lung function. The two pharmaceutical firms are now planning on submitting an sBLA – supplemental Biologics License Application to the U.S. Food and Drug Administration before the year ends based on data from the study.
On Tuesday shares of Sanofi SA edged downwards by 0.09% to close the day at $49.59.
