GlycoMimetics, Inc. (Nasdaq: GLYC) today announced that patient enrollment has been completed in the Phase 3 RESET (Rivipansel: Evaluating Safety, Efficacy and Time to Discharge) clinical trial, which is evaluating the efficacy and safety of rivipansel for the acute treatment of vaso-occlusive crisis (VOC) in sickle cell disease (SCD). In 2011, GlycoMimetics and Pfizer Inc. (NYSE:PFE) entered into a worldwide license agreement for the development and, if approved by applicable regulatory authorities, commercialization of rivipansel. Since completion of the Phase 2 clinical trial, Pfizer, has been responsible for clinical development of rivipansel, including the RESET clinical trial.
“This is an important milestone for the development of rivipansel, bringing us one step closer to potentially addressing one of the most severe complications of sickle cell disease,” said GlycoMimetics Senior Vice President of Clinical Development and Chief Medical Officer Helen Thackray, M.D., FAAP. “We have great hope for the potential impact this treatment could have on individuals living with sickle cell and their families and look forward to seeing the top-line results.”
Rivipansel has received Orphan Drug and Fast Track status from the U.S. Food and Drug Administration (FDA). Rivipansel is an investigational pan-selectin inhibitor. The selectins have been shown to play a role in cell adhesion and inflammation. By inhibiting the selectins, rivipansel is believed to enhance blood flow through the microvasculature during VOC and reduce the pain and organ damage associated with VOC. Rivipansel is not a narcotic or a pain medication
Under the Company’s license agreement, GlycoMimetics is eligible to receive payments of up to $80 million upon the achievement of specified development milestones, up to $70 million upon the achievement of specified regulatory milestones, and up to $135 million upon the achievement of specified levels of annual net sales of licensed products. GlycoMimetics is also eligible to receive tiered royalties, with percentages ranging from the low double digits to the low teens, based on net sales of rivipansel worldwide.