BPGbio Inc (BPG), an AI-powered biopharma with a mission to reimagine biology for humanity, announced today that the company has reached a partnership agreement with Dystrophic Epidermolysis Bullosa Research Association of America (debra of America) for BPGbio’s BPM 31510 for Epidermolysis Bullosa Phase II/III trial, which is anticipated to launch in the second half of the year. Through the partnership, debra of America will provide support to awareness, understanding, and key information towards patient recruitment and advocacy for the clinical trial.

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 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.

“We are pleased to expand our partnership with debra of America to our BPM 31510 for EB Phase II/III trial,” said Niven R. Narain, Ph.D., President and CEO of BPGbio. “This is an important milestone in our efforts to launch the next phase of clinical development for our EB drug candidate later this year.”

Since 2017, BPGbio has been working with debra of America using BPGbio’s expertise and innovative research platforms to provide scientific support and advocate on behalf of patients and families affected by EB. BPGbio’s EB Drug Candidate (BPM 31510) Received FDA Orphan-Drug Designation.

“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 S. Kirsner, M.D., Ph.D., Chairman & 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.”

“Having seen the encouraging results from BPBbio’s Phase I trial for EB, we are excited to partner with them on the next phase and create meaningful advancements that positively impact the EB community,” commented Brett Kopelan, Executive Director of debra of America and father to 15-year-old with a severe form of the disease.

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.

About BPGbio, Inc.

BPGbio Inc, is a leading AI-powered, human-biology-focused biopharmaceutical company headquartered in the greater Boston, Massachusetts area. With its intelligent Interrogative Biology platform and the largest clinically annotated non-governmental biobank in the world, BPGbio is reimagining how patient biology can be modeled using unbiased AI to accelerate and de-risk the process of drug discovery across oncology, neurology, and rare diseases. Learn more at www.bpgbio.com

About debra of America

Debra of America, part of DEBRA International, a worldwide network of national groups working on behalf of all people living with Epidermolysis Bullosa (EB).

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