Pfizer announced topline results from the phase 3 RESET study evaluating rivipansel (GMI-1070) for the treatment of patients with sickle cell disease (SCD) aged 6 years and older, who were hospitalized for a vaso-occlusive crisis (VOC) and required treatment with intravenous (IV) opioids.
In the multicenter, double-blind, placebo-controlled, parallel-group RESET study, patients (N=345) were randomized 1:1 to receive rivipansel or placebo IV every 12 hours for up to 15 doses. The primary end point was time to readiness for discharge, defined as the difference between the readiness-for-discharge date and time and the start date and time of the first infusion of study drug; key secondary efficacy end points included time to discharge, cumulative IV opioid consumption, and time to discontinuation of IV opioids.
Results showed the study did not meet its primary or key secondary efficacy end points. Full detailed data from the trial will be submitted for presentation at a future scientific meeting.
“We are 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,” said Brenda Cooperstone, MD, Senior Vice President and Chief Development Officer, Rare Disease, Pfizer Global Product Development. “We express our sincere gratitude to everyone who made this study possible, including the study investigators, and in particular, the patients and their families.”
For more information visit pfizer.com.