November 11, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Regeneron Pharmaceuticals, Inc. and French partner Sanofi ’s positive results today for a Phase 2b study of asthma drug dupilumab holds an enormous amount of promise for both investors and clinicians looking for a “potential blockbuster” for the treatment of allergic diseases, biotech analyst Joshua Schimmer said Tuesday.
Today the companies announced positive from the study of of dupilumab and standard of care in 776 adults with uncontrolled moderate to severe asthma. Dupilumab had broad efficacy in all patients, but the response was strongest in patients with high eosinophils. Dupilumab also reduced the annualized rate of severe exacerbations.
Those results are good news for both firms, said Schimmer, who is with Piper Jaffray.
“The partners plan to advance dupilumab into Phase III trials based on these data,” he wrote in a note to investors. “When combined with the positive data in sinusitis and dermatitis, we are optimistic for dupilumab’s broad potential in allergic diseases.”
The data released today was from a pre-specified interim analysis when patients reached 12 weeks of treatment, out of a 24 week protocol. Currently, the average treatment duration is 21.5 weeks.
Both the overall population and the high eosinophil patients saw significant reductions in severe exacerbations ranging from 64 percent to 75 percent, while adverse events were balanced between the dosing groups and placebo. The partners plan to advance dupilumab into Phase III asthma trials based on these data.
All of those numbers are encouraging enough to have Wall Street wondering if the drug has the potential to be a major tool in treating allergic diseases going forward.
“Dupilumab’s mechanism of targeting IL-4/IL-13 seems to offer an efficacious therapy for treating a broad range of allergic diseases,” said Schimmer in his note. “Today’s data in asthma, the recent results in sinusitis and commencement of Phase III trials in atopic dermatitis position dupilumab to have blockbuster potential in allergic conditions.”
