In a pivotal phase III trial, rivipansel failed to meet its primary and secondary efficacy endpoints in patients with sickle cell disease (SCD) who experienced a vaso-occlusive crisis (VOC).
Rivipansel is a pan-selectin inhibitor that blocks the activity of cell adhesion molecules in the blood vessels. The randomized, placebo-controlled RESET trial evaluated the efficacy and safety of rivipansel in 345 patients with SCD (age ≥6 years) who were hospitalized for a VOC and required treatment with intravenous (IV) opioids.
The trial’s primary endpoint was time to readiness-for-discharge; secondary efficacy endpoints included time-to-discharge, cumulative IV opioid consumption, and time to discontinuation of IV opioids. None of the endpoints were met.
Pfizer and GlycoMimetics, the manufacturers of rivipansel, said that the results are “disappointing,” noting that they plan to share the study data at an upcoming scientific meeting “to ensure the [findings] from this trial help inform future sickle cell programs that aim to improve care for SCD patients experiencing a VOC.”
Source: Pfizer press release, August 2, 2019.