Phase 2b trial of glioblastoma drug announced after successful phase 1a/b study

A Boston-area biopharma company announced positive data from a phase 1a/b trial of a novel therapeutic to treat newly diagnosed glioblastoma multiforme, resulting in the initiation of a first-line phase 2b study.

According to a press release from BPGbio Inc., the phase 2b trial was planned after the completion of the phase 1a/b clinical trial, which demonstrated safety, efficacy and tolerability of BPM31510 in 104 participants.

Results from that trial allowed the company to create a patient-based artificial intelligence model to further knowledge and understanding of the compound’s mechanism of action, while predicting who may be most likely to respond to the therapy, according to the release.

BPM31510, a treatment for glioblastoma multiforme, which each year strikes nearly 13,000 Americans aged older than 60 years, previously received orphan drug designation from the FDA.

“The initial data from our ongoing clinical development of BPM31510 suggests early promise and brings new hope to patients with some of the most aggressive and difficult-to-treat cancers of the brain and pancreas. It also validates our biology-first AI approach to making clinical development more efficient,” BPGbio President and CEO Niven R. Narain, PhD, said in the release.

The phase 2b study, under which 50 patients will be enrolled, is a single arm dose-confirmation trial where administration of BPM31510 is complemented with vitamin K and standard chemoradiation therapy.

BPGbio additionally revealed its plans to expand the phase 2b trial to new sites in the United States and the United Kingdom.