Arena Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation status to etrasimod, a highly selective, once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator, for the treatment of eosinophilic esophagitis (EoE).
Etrasimod is being investigated in the Phase 2b VOYAGE trial, a randomized, double-blind, placebo-controlled trial, with a primary efficacy measurement at week 16 and a secondary efficacy analysis at week 24, to assess the safety and efficacy of 1 mg and 2 mg etrasimod in approximately 100 participants with EoE.
“The granting of Orphan Drug Designation for etrasimod for EoE is not only good news for Arena, but more importantly for the patients living with EoE, as there are currently no FDA approved therapies for this patient population,” said Paul Streck, MD, Senior Vice President and Chief Medical Officer of Arena. “We look forward to our continued collaboration with our investigators participating in the Phase 2b VOYAGE trial and the FDA as we strive to bring a potentially important therapy to these patients.”