Pfizer announced that the Phase 3 Rivipansel (GMI1070): 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.
“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. We plan 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,”
said Brenda Cooperstone, M.D., 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.”
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.
“We recognize this is a significant setback for the SCD community, who are eagerly awaiting new treatment options, and we share in their disappointment,”
said Freda Lewis-Hall, M.D., DFAPA, Chief Patient Officer and Executive Vice President, Pfizer Inc.
“Many of us have witnessed first-hand the devastating impact of SCD on patients and their families, but we have also been moved by their incredible strength and bravery, and we will continue to support this courageous community.”
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.