BPGbio Expands Partnership with debra of America for Epidermolysis Bullosa Phase 2/3 Trial

Rare Daily Staff

AI-powered biopharma BPGbio has reached a partnership agreement with debra for America for BPGbio’s phase 2/3 trial of BPM 31510 for epidermolysis bullosa, which is anticipated to launch in the second half of the year.

“This is an important milestone in our efforts to launch the next phase of clinical development for our EB drug candidate later this year,” said Niven Narain, president and CEO of BPGbio.

Debra of America is part of DEBRA International, a worldwide network of national groups working on behalf of all people living with EB. BPGbio has been working with debra of America since 2017, using BPGbio’s expertise and innovative research platforms to provide scientific support and advocate on behalf of patients and families affected by EB.

Through the partnership, the Dystrophic Epidermolysis Bullosa Research Association of America (debra of America) will provide support to awareness, understanding, and key information towards patient recruitment and advocacy for the clinical trial.

Epidermolysis bullosa (EB) is a rare, pervasive, and debilitating connective tissue disorder with many genetic and symptomatic variations that affects approximately one in every 20,000 children born in the U.S. The disease significantly diminishes the quality of life for those living with it, and in the more severe cases, patients may succumb at an early age from a multitude of reasons including a severe form of squamous cell carcinoma.

Preliminary evidence from the phase 1 clinical trial suggests BPGbio’s BPM 31510 appears to be well tolerated and potentially efficacious in improving wound healing in all sub-types of EB patients. Preclinical data demonstrate that BPGbio’s BPM 31510 influences several key elements of the wound healing process to help in the treatment and management of EB wounds.

“BPGbio’s topical agent for EB has demonstrated encouraging signs of efficacy in a disease setting where wound healing is most difficult and contributes to significant morbidity,” said Robert Kirsner, chairman and Harvey Blank professor in the Dr. Phillip Frost Department of Dermatology & Cutaneous Surgery, University of Miami Miller School of Medicine. “We look forward to observing late-stage studies for confirmation of efficacy and safety and the tremendous hope it offers to reduce disease burden for patients, families, and caregivers in EB.”

BPGbio’s EB therapeutics are a vital component of its acquisition of substantially all assets of BERG, LLC in January 2023, which includes BERG’s proprietary Interrogative Biology Platform, a strong pipeline consisting of more than a dozen promising candidates in the areas of oncology, neurology and rare diseases and a robust portfolio of more than 400 U.S. and international granted and pending patents.

Photo: Niven Narain, president and CEO of BPGbio