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BPGbio Announces Completion of Enrollment for Phase 2b Trial of BPM31510 for Glioblastoma (GBM)

By: BPGbio via GlobeNewswire

September 04, 2025 at 07:00 AM EDT

Topline Phase 2b Clinical Data Expected in 1H 2026
Trial-in-Progress Presentations Scheduled for ESMO and SNO in Fall 2025
BPM31510 has Received Orphan Drug Designation from the U.S. FDA for the Treatment of GBM

BOSTON, Sept. 04, 2025 (GLOBE NEWSWIRE) -- BPGbio Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, today announced the completion of enrollment in its Phase IIb trial of BPM31510-IV, in combination with Vitamin K1, for patients with newly diagnosed glioblastoma multiforme (GBM).

Following a Phase 1 study in GBM, demonstrating acceptable tolerability and safety, the Phase 2b study enrolled 50 eligible patients aged 18 to 75 across multiple U.S. sites, reflecting strong interest from both patients and investigators in BPM31510. The study is led by Seema Nagpal, MD, Clinical Professor of Neurology and Neurological Sciences, Stanford Medicine.

Trial-in-progress data will be presented at the European Society for Medical Oncology (ESMO) Congress 2025 in October, followed by Society of Neuro-Oncology (SNO) Annual Meeting 2025 in November, with topline results from the trial expected in Q2 2026.

The trial (NCT04752813) is a single-arm, multicenter, open-label Phase IIb study designed to evaluate the safety, efficacy and tolerability of adding BPM31510- IV and vitamin K1 delivered in a front-line setting prior to standard of care radiation therapy and temozolomide (TMZ) treatment in patients with newly diagnosed GBM. The primary end point of the trial is progression free survival (PFS) at 6 months.

Glioblastoma remains one of the most aggressive malignancies, with five-year survival below 10%. Nearly all patients relapse following standard-of-care therapy, which includes surgical resection, radiation therapy and/or chemotherapy with TMZ. The poor prognosis highlights the need for novel approaches that address the fundamental biology of the disease. GBM is characterized and driven by certain mitochondrial alterations, most notably metabolic reprogramming (the Warburg effect) and a decreased capacity to undergo apoptosis, leading to its highly aggressive phenotypes.

“Completing enrollment in our Phase 2b GBM trial is a testament to the strong collaboration with our clinical sites and the enthusiasm within the community for advances in GBM, an area of research that has not seen major therapeutic innovation in decades,” said Vijay Modur, MD, Ph.D., Chief Medical Officer, BPGbio. “BPM31510 has shown the ability to prolong survival in animal models and demonstrated activity in both human GBM cell systems and orthotopic glioma models. These findings provide strong scientific rationale as we move forward in evaluating its potential in this devastating disease.”

BPM31510 is a ubidecarenone (CoQ10) containing nanoliposome dispersion positioned to target the mitochondrial tumor microenvironment (TME) to increase ROS and restore the apoptotic potential in GBM. The nanotechnology is designed to deliver supraphysiological levels of oxidized CoQ10 directly to the inner mitochondrial membrane, which can trigger programmed cell death pathways and reverse Warburg-like metabolic phenotypes in tumor cells. BPGbio employed the full power of its biology-first AI platform, the NAi Interrogative Biology platform to unravel the molecular mechanism of action of BPM31510, assess clinical safety and toxicity signals, and guide clinical development of BPM 31510 for GBM.

“We are grateful to the patients and families who have participated in our clinical trial,” said Niven R. Narain, Ph.D., President and CEO of BPGbio. “This milestone represents not just the completion of enrollment, but real progress in advancing a therapy designed to reprogram tumor metabolism. With upcoming presentations at ESMO and SNO and a topline data readout expected in 2026, we are eager to see how BPM31510 can translate into meaningful benefit for patients with GBM.”

About BPM31510

BPM31510IV is BPGbio’s lead candidate in late-stage development for aggressive solid tumors such as glioblastoma multiforme (GBM) and pancreatic cancer. Other topical and oral formulations of the investigational agent are also being developed as a potential treatment for several rare diseases including Primary CoQ10 Deficiency (PCQD). The compound has demonstrated a tolerable safety profile and is being studied for potential clinical benefits across multiple disease indications. Validated by BPGbio’s NAi Interrogative Biology platform, BPM31510 is designed to induce a hallmark shift in the tumor microenvironment (TME) by modulating mitochondrial oxidative phosphorylation in aggressive tumors, promoting programmed cell death (apoptosis). In many mitochondrial diseases, restoring CoQ₁₀ levels can overcome the effect of mutations in genes that lead to mitochondrial dysfunction. BPM31510 has been granted Orphan Drug Designation by the FDA for GBM, pancreatic cancer, and epidermolysis bullosa (EB), as well as Rare Pediatric Disease Designation for primary CoQ10 deficiency and EB.

About BPGbio

BPGbio is a leading biology-first AI-powered clinical stage biopharma focused on mitochondrial biology and protein homeostasis. The company has a deep pipeline of AI-developed therapeutics spanning oncology, rare disease and neurology, including several in late-stage clinical trials. BPGbio’s novel approach is underpinned by NAi, its proprietary Interrogative Biology Platform, protected by over 500 US and international patents; one of the world’s largest clinically annotated non-governmental biobanks with longitudinal samples; and exclusive access to the most powerful supercomputer in the world. With these tools, BPGbio is redefining how patient biology can be modeled using bespoke Bayesian AI specifically designed for solving large-scale biology challenges. Headquartered in greater Boston, the company is at the forefront of a new era in medicine, combining biology, multi-modal data, and AI to transform the way we understand, diagnose, and treat disease. For more information, visit www.bpgbio.com.

Contact

media@bpgbio.com