Biodexa Pharmaceuticals Plc (NASDAQ: BDRX) has seen its stock price experience a remarkable surge following a significant regulatory development. As of the latest premarket check, BDRX shares have risen by 108.40%, trading at $8.48. This increase is attributed to the company’s announcement regarding a crucial regulatory approval.
FDA’s Fast Track Designation for eRapa
Biodexa (BDRX) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to eRapa, a special encapsulated form of rapamycin. The designation aims to speed up the process of creating and evaluating drugs that address significant unmet medical needs and treat severe disorders. Specifically, eRapa is being researched as a treatment for familial adenomatous polyposis (FAP), which often leads to colorectal cancer if left untreated.
FAP and the Requirement for Novel Therapies
A hereditary condition known as FAP causes several polyps to form in the colon and rectum, usually first appearing in adolescence. FAP always develops into colorectal cancer if therapy is not received, and the only available choices are colon and rectum surgical resection. The condition has no approved therapeutic alternatives, making eRapa’s potential a highly significant breakthrough in the field.
Promising Phase 2 Results
Biodexa’s Phase 2 study of eRapa has shown promising results. The drug demonstrated safety and tolerability, with a 17% median reduction in polyp burden after 12 months, compared to baseline measurements.
Notably, 75% of patients in the trial experienced no disease progression. The cohort receiving the preferred dosing regimen of every other day showed even more encouraging outcomes, including an 89% non-progression rate and a 29% median reduction in polyp burden.
Next Steps and Regulatory Designation Plans
In addition to the Fast Track designation, eRapa has already received the FDA’s Orphan Drug status for FAP, and the company plans to seek similar recognition in Europe as it prepares for its upcoming Phase 3 study.