FDA Grants Fast Track Designation for Biodexa’s eRapa in Familial Adenomatous Polyposis

February 10, 2025

DENVER, Colo., Feb 10, 2025 (247marketnews.com)- Biodexa Pharmaceuticals (NASDAQ:BDRX) reported that the US Food and Drug Administration (“FDA”) granted Fast Track designation for eRapa. eRapa is Biodexa’s proprietary encapsulated form of rapamycin for the treatment of familial adenomatous polyposis (FAP). Fast track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

The move signals the FDA’s recognition of the urgency in finding a treatment for FAP, which currently has no approved therapeutic options. Biodexa could receive more frequent communications from the FDA, which can help accelerate the clinical trials and regulatory approval process.

FAP is a genetic condition with a reported prevalence of about 1 in 5,000 to 10,000 people in the US and characterized by the proliferation of polyps in the colon and rectum, which, if untreated, leads to colorectal cancer. The only current treatment options are surgical resection, which involves the removal of the colon and/or rectum, a highly invasive and debilitating procedure. eRapa aims to offer a non-surgical treatment option, potentially improving the quality of life for patients by reducing the need for invasive surgeries and helping to manage the disease.

The Phase 2 study of eRapa showed promising results, including a 17% median reduction in total polyp burden after 12 months compared to baseline. For cohort 2, patients had a 29% median reduction in polyp burden and an 89% non-progression rate after 12 months.

These results suggest that eRapa can effectively reduce the growth of polyps, which is key to preventing the progression to colorectal cancer. The non-progression rate of 89% in cohort 2 is particularly notable, as it implies that the majority of patients had no worsening of their condition, which is a significant improvement over the current standard of care.

The Phase 3 study will use the preferred dosing regimen from cohort 2: daily every other week. This regimen was identified as having the most favorable results in terms of efficacy and safety, and it will be crucial for Biodexa to demonstrate eRapa’s benefit in a larger patient population during Phase 3 trials.

Phase 3 trials are typically the final stage before a drug is submitted for approval, and the results will be essential in determining whether eRapa can be approved as a treatment option for FAP.

The FDA granted eRapa Orphan Drug designation for FAP, which provides tax incentives, marketing exclusivity for a period (7 years in the US), and other benefits that can help accelerate the drug’s development for rare diseases like FAP.

Biodexa plans to seek similar designation in Europe, which could further support eRapa’s development and commercial viability in both the US and European markets.

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