8 May 2019 - - 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 in sickle cell disease, US-based biotechnology company GlycoMimetics, Inc. (NASDAQ: GLYC) said.

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.

Rivipansel has received Orphan Drug and Fast Track status from the US Food and Drug Administration. 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 USD 80m upon the achievement of specified development milestones, up to USD 70m upon the achievement of specified regulatory milestones, and up to USD 135m 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.

SCD is the most common inherited blood disease impacting approximately 100,000 people in the United States, predominantly of African descent.

One of the most severe complications of SCD is VOC, which is typically characterized by excruciating, debilitating pain that occurs periodically throughout the life of a person with SCD. Acute care encounters, including hospitalisations and rehospitalisations, due to VOC are frequent, particularly for 18 to 30-year old.

Based on published rates of health care utilization by people with SCD, there are in excess of 100,000 hospitalisations due to VOC each year in the United States with an average hospital stay of six days.

The current standard of care for VOC consists of supportive therapy, primarily in the form of hydration and pain management, typically requiring extended hospitalisation.

GlycoMimetics is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role.

GlycoMimetics' most advanced drug candidate, rivipansel, a pan-selectin antagonist, is currently being developed for the treatment of vaso-occlusive crisis in sickle cell disease in a Phase 3 trial being conducted by Pfizer Inc., the exclusive licensee of rivipansel for clinical development and worldwide commercialization.

GlycoMimetics' wholly owned drug candidate, uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial as a potential treatment for AML and is being evaluated across a range of patient populations including a company-sponsored Phase 3 trial in relapsed/refractory AML. 

GlycoMimetics has also completed a Phase 1 clinical trial with a third drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region.