Ph III rivipansel trial in sickle cell patients fails goals
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, according to an announcement on Friday by US pharma giant Pfizer (NYSE: PFE).
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.
Pfizer acquired rights to the compound under a potentially $340 million licensing deal with US biotech firm GlycoMimetics (Nasdaq: GLYC) in 2011.Rivipansel had previously been forecast to achieve $104 million in sales in 2024, earning $34 million in royalties for GlycoMimetics, according to EvaluatePharma's consensus of sell-side analysts.
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