PhaseBio’s Brilinta reversal drug has scored a midstage win without any adverse events or blood clot issues, layering on the data to support the therapy that’s already pushing through phase 3.
Bentracimab, also known as PB2452, was licensed from AstraZeneca to provide a reversal agent for the Big Pharma’s stroke medicine Brilinta. PhaseBio’s drug is meant to be administered to patients taking Brilinta in emergency bleeding situations or when they are in need of urgent surgery.
The phase 2b trial was conducted in 200 healthy volunteers, with 150 taking the therapy. All patients were given the AstraZeneca drug and a platelet function test to assess the efficacy of bentracimab. The main goal was to reverse Brilinta’s inhibition of platelet function compared to placebo, which was met.
Safety was consistent with earlier phase 1 and 2a trials, PhaseBio said, with no drug-related serious adverse events or blood clot concerns arising. Common adverse events reported were injection site bruising and headaches, with similar rates in the treatment and placebo groups.
PhaseBio Chief Medical Officer John Lee, M.D., Ph.D., said the latest results help build the case for a regulatory filing for bentracimab. The midstage efficacy results are consistent with what the biotech saw in earlier studies.
The phase 1 trial was also conducted in healthy volunteers who received just Brilinta without aspirin. The phase 2a was similar but looked at the addition of low-dose aspirin to the regimen.
A phase 3 called Reverse-It is also underway, this time in patients who are in an emergency situation. PhaseBio is conducting the test at major medical centers around the world to determine if the therapy works in patients who have uncontrolled major or life-threatening bleeding, those who require urgent surgery or need an invasive procedure. The study will enroll about 200 people who have taken Brilinta within three days of seeking medical care.
PhaseBio will present interim results from the study on Nov. 15 at the American Heart Association’s Scientific Sessions 2021. Pending the results from the late-stage test, the biotech plans to file for approval with the FDA in mid-2022.
The company has already signed a manufacturing partner, CDMO BioVectra, to prepare for a commercial launch.