Phase III (RESET) pivotal study of rivipansel did not meet its primary or key secondary efficacy endpoints in patients with Sickle Cell Disease

Pfizer Inc. announced that the Phase III rivipansel (GMI-1070): Evaluating Safety, Efficacy and Time to Discharge (RESET) pivotal study did not meet its primary or key secondary efficacy endpoints. The objective of the trial was to evaluate the efficacy and safety of rivipansel in patients aged six and older with sickle cell disease (SCD) who were hospitalized for a vaso-occlusive crisis (VOC) and required treatment with intravenous (IV) opioids.

The primary endpoint was time to readiness-for-discharge and the key secondary efficacy endpoints were time-to-discharge, cumulative IV opioid consumption, and time to discontinuation of IV opioids. SCD is a debilitating blood disorder, characterized by acute pain crises or VOC. Treatment options for patients seeking medical care for a VOC are currently limited to symptomatic management with analgesics (including opioids and NSAIDs) and hydration, underscoring a significant need for new treatment options.Detailed analyses of the RESET study, including additional data on efficacy and safety endpoints, which are not available at this time, will be submitted for presentation at a future scientific meeting.