BPM31510

BPM31510 (ubidecarenone) is BERG’s leading product candidate. BPM31510 works by correcting cancer cell metabolism, thereby reactivating apoptosis.

BPM31510 is currently progressing through clinical trials for the treatment of a number of solid tumors. Early phase trials have appeared to demonstrate anti-tumor activity with an acceptable safety profile.

The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to BPM31350 for the treatment of pancreatic cancer and epidermolysis bullosa in January 2018 and May 2018, respectively.

BPM31510 is also being tested in a type of brain tumor called glioblastoma multiforme, a type of skin cancer called squamous cell carcinoma, a number of other solid tumors and a skin disorder called epidermolysis bullosa.

BPM31510 in clinical development

Solid Tumors | Monotherapy and Combination therapy | Intravenous

Discovery Complete
Preclinical Complete
Phase 1 Complete
Phase 2
Phase 3

This is an open label trial evaluating BPM 31510 as a single agent in patients with advanced refractory solid tumors. Trials are on-going at MD Anderson Cancer Center.

Pancreatic Tumors | Monotherapy and Combination therapy | Intravenous

Discovery Complete
Preclinical Complete
Phase 1 Complete
Phase 2 Complete
Phase 3

This is a Phase II open-label, non-randomized clinical trial in patients with pancreatic cancer with trials being conducted at Beth Israel Deaconess Medical Center, Mayo Clinic, the Medical College of Wisconsin and Vita Medical Associates.

Glioblastoma Multiforma | Monotherapy | Intravenous

Discovery Complete
Preclinical Complete
Phase 1 Complete
Phase 2
Phase 3

This is a phase I open-label, non-randomized clinical trial in patients with glioblastoma that has recurred on a bevacizumab-containing regimen. The trial is conducted at Stanford Cancer Institute.

Squamous Cell Carcinoma | Monotherapy | Topical – cream

Discovery Complete
Preclinical Complete
Phase 1 Complete
Phase 2 Complete
Phase 3

This Phase II trial in patients with Squamous Cell Carcinoma has been completed. A strategy for launch of a late stage trial focused on product registration is currently under assessment.

Epidermolysis Bullosa | Monotherapy | Topical – cream

Discovery Complete
Preclinical Complete
Phase 1 Complete
Phase 2
Phase 3

This is a phase I open label, non-randomized clinical trial in patients 12 years and older with any form of Epidermolysis Bullosa. The investigator initiated study is conducted at the University of Miami.