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news.Pfizer’s rivipansel has failed to meet its primary and key secondary efficacy endpoints in phase 3 study of sickle cell disease (SCD).
Image: Pfizer world headquarters in Manhattan, New York. Photo: courtesy of Coolcaesar.
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The phase 3 rivipansel evaluating safety, efficacy and time to discharge (RESET) study evaluated 345 patients who were randomised 1:1 to receive rivipansel or placebo, administered intravenously every 12 hours to a maximum of 15 doses.
The study’s objective was to assess the efficacy and safety of rivipansel in patients aged six and older with sickle cell disease (SCD) who were hospitalised for a vaso-occlusive crisis (VOC) and required treatment with intravenous (IV) opioids.
According to the company, the primary endpoint was time to readiness-for-discharge, while the major secondary efficacy endpoints were time-to-discharge, cumulative IV opioid consumption, and time to discontinuation of IV opioids.
Pfizer global product development rare disease chief development officer and senior vice president Dr Brenda Cooperstone 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.”
Rivipansel, an investigational treatment for VOC in people with SCD, is not yet approved for use.
In 2011, Pfizer signed a worldwide licence agreement with GlycoMimetics for the development of rivipansel. The deal will also allow commercialisation of rivipansel, if approved by regulatory authorities.
SCD is the most common inherited blood disorder, which is affecting around 100,000 people in the US and around 100 million people across the globe.
Pfizer chief patient officer and executive vice president Dr Freda Lewis-Hall 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.”
In July this year, Pfizer secured approval from the US Food and Drug Administration (FDA) for its Ruxience (rituximab-pvvr), a biosimilar to Roche’s cancer drug Rituxan (rituximab), to treat certain cancers and autoimmune conditions.
