Pfizer announced that a Phase III study of the experimental drug rivipansel in patients aged six and older with sickle cell disease (SCD) who were hospitalised for a vaso-occlusive crisis (VOC) failed to meet its primary or key secondary efficacy endpoints. "We are disappointed with the results" from the RESET trial, remarked Brenda Cooperstone, chief development officer of rare disease global product development.
In 2011, Pfizer licensed worldwide rights to rivipansel, previously known as GMI-1070, from GlycoMimetics as part of a deal valued at approximately $340 million. Shares in GlycoMimetics fell as much as 53% on results of the RESET study.
The trial randomised 345 patients with SCD aged six and older, who were hospitalised for a VOC and required treatment with intravenous (IV) opioids to receive rivipansel or placebo, administered intravenously every 12 hours to a maximum of 15 doses. The study's main goal was time-to-readiness for discharge, defined as the difference between the start time and date of the first infusion of study drug and the time and date of medical staff-assessed readiness-for-discharge, while key secondary endpoints were time-to-discharge, cumulative IV opioid consumption and time to discontinuation of IV opioids.
Pfizer noted that detailed analyses of the study, including additional data on efficacy and safety endpoints, which are not yet available, will be presented at an upcoming medical meeting.
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