RESET clinical trial results : US pharma giant Pfizer’s rivipansel failed to meet the primary and key secondary efficacy endpoints of a phase 3 trial called RESET in sickle cell disease (SCD).
The aim of the RESET clinical trial was to assess the efficacy and safety of rivipansel in sickle cell disease patients, aged six and older, who were hospitalized for a vaso-occlusive crisis (VOC) and needed treatment with intravenous (IV) opioids.
The primary endpoint of the phase 3 sickle cell disease trial was time to readiness-for-discharge. On the other hand, the key secondary efficacy endpoints of the RESET clinical trial were time-to-discharge, time to discontinuation of IV opioids, and cumulative IV opioid consumption.
Commenting on the RESET clinical trial results of rivipansel, Brenda Cooperstone -Senior Vice President and Chief Development Officer, Rare Disease, Pfizer Global Product Development, said: “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.
“We express our sincere gratitude to everyone who made this study possible, including the study investigators, and in particular, the patients and their families.”
The RESET clinical trial had enrolled 345 patients, who were randomly grouped 1:1 to be treated with rivipansel or placebo, which were intravenously administered every 12 hours to a maximum of 15 doses. All the participants of the RESET clinical trial were followed for safety for 35 days after the completion of the last dose of rivipansel.
Freda Lewis-Hall – Chief Patient Officer and Executive Vice President, Pfizer, commenting on the RESET clinical trial results of rivipansel, said: “We recognize this is a significant setback for the SCD community, who are eagerly awaiting new treatment options, and we share in their disappointment.
“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.”
For more clinical trial news like the RESET clinical trial results of rivipansel, keep following Pharma News Daily.