Biodexa Pharmaceuticals Plc (NASDAQ: BDRX) shares are going through a remarkable surge on the charts today, rising 14.36% to $4.42, following updates on its transformative acquisitions. BDRX has strategically shifted from being a drug delivery innovator to a therapeutics-focused entity targeting diabetes and cancer treatment.
Biodexa’s Strategic Focus on Repurposed Therapeutics
Biodexa’s approach prioritizes minimizing clinical risk by repurposing molecules with established safety profiles for new applications. Instead of discovering new drugs, BDRX acquires promising products through licensing agreements, bearing development costs while sharing commercialization profits with licensors. This risk-averse model is central to its recent success.
One notable acquisition is eRapa, a potential treatment for familial adenomatous polyposis (FAP), a hereditary condition significantly increasing the risk of colorectal cancer. Currently, FAP patients face limited options, with standard care involving intensive surveillance and eventual surgical removal of the colon. With Phase 2 results demonstrating a 29% median reduction in polyp burden and an 89% non-progression rate in patients following the recommended dosing regimen, eRapa provides a revolutionary option.
Secured Funding and Regulatory Pathway
The Cancer Prevention Research Institute of Texas awarded a $17 million grant to Biodexa’s eRapa initiative, which was augmented by a matching fund. BDRX hopes to submit a New Drug Application (NDA) to the FDA in three years, with finance mainly secured. Recruitment is anticipated to start in early 2025, and preparations are in progress for a “Type C” meeting with the FDA to complete the Phase 3 research protocol.
Expanding the Pipeline
Beyond eRapa, Biodexa is advancing other promising therapeutics. These include a placebo-controlled Phase 2 trial of eRapa for non-muscle invasive bladder cancer (NMIBC) and a Phase 2a dose confirmation study of tolimidone for Type 1 diabetes, which targets pancreatic beta cell regeneration.
Bright Prospects in Rare Diseases
With an orphan drug designation, eRapa could secure exclusivity for seven years in the U.S. and 10 years in Europe. Its peak annual sales potential ranges from $500 million to $1 billion. As Biodexa progresses with pivotal trials and regulatory engagements, it stands poised to make significant contributions to addressing unmet medical needs.
