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.
BPGBio Inc is an artificial intelligence powered biopharma that has reached a partnership agreement with Dystrophic Epidermolysis Bullosa Research Association of America (Debra of America) for BPGBio’s drug BPM31510 phase 2/3 trial anticipated to launch in the second half of this 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.
“We are pleased to expand our partnership with debra of America to our BPM 31510 for EB trial,” said Niven Narain, 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.”
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.
“Having seen the encouraging results from BPBbio’s phase one trial for EB, we are excited to partner with them on the next phase and create meaningful advancements that positively impact the EB community,” added Brett Kopelan, executive director of debra of America and father to 15-year-old with a severe form of the disease.”
The company says preliminary evidence from phase 1 clinical trial suggests its 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 it influences several key elements of the wound healing process to help in the treatment and management of EB wounds.
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. The drug candidate received FDA Orphan-Drug Designation.
Robert Kirsner of the University of Miami Miller School of Medicine said: “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.
“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 BiologyPlatform, 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.
