Pfizer has announced that in a Phase III RESET trial, Rivipansel (GMI-1070) did not meet its primary or secondary endpoints for sickle cell disease (SCD) related occlusive crisis (VOC).
The objective of the trial was to evaluate the efficacy and safety of Rivipansel in patients aged six and older with the disease who required treatment with intravenous (IV) opioids for their VOC.
The primary endpoint and key secondary efficacy endpoints, of which neither were met, were readiness-for-discharge, time-to-discharge, cumulative IV opioid consumption, and time to discontinuation of IV opioids respectively.
The company say that it is “disappointed with the results, as we have been working in close partnership with the SCD community to advance rivipansel as a potential treatment option for acute VOC”, and mention that it plans to “share the study data at an upcoming scientific meeting as we want to ensure the learnings from this trial help inform future sickle cell programs that aim to improve care for SCD patients experiencing a VOC.”
SCD is a debilitating blood disorder, characterised 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.
Pfizer have noted that the failure is a ‘significant setback’ for the community, and say that they “will continue to support this courageous community.”