GAITHERSBURG, Md. - GlycoMimetics, Inc. (NASDAQ:GLYC) announced that Pfizer Inc., the company responsible for ongoing clinical development for rivipansel (GMI-1070), has reached agreement with the U.S. Food & Drug Administration (FDA) under a special protocol assessment (SPA) for a Phase 3 trial for rivipansel. A SPA is a written agreement between a trial’s sponsor (in this case,Pfizer) and the FDA regarding the design, endpoints and statistical analysis approach of a Phase 3 clinical trial, results from which could potentially support approval of a New Drug Application (NDA). Rivipansel is being developed as a potential therapy for treatment of patients with sickle cell disease who are hospitalized for vaso-occlusive crisis (VOC).
Rivipansel has previously received both Orphan Drug and Fast Track status for the treatment of VOC from the FDA. Pfizer plans to begin the Phase 3 program before the end of 2014.
“There is an enormous need in the sickle cell community for new therapies to treat this debilitating disease,” said Helen Thackray, M.D., Vice President of Clinical Development and Chief Medical Officer at GlycoMimetics. “We feel that the FDA reaching agreement with Pfizer on an SPA is extremely important because there are currently no approved medicines for this particular indication and, therefore, the regulatory path to potential approval has not been previously defined.”