Biodexa Pharmaceuticals Plc ((BDRX)) announced an update on their ongoing clinical study.
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Study Overview: The Phase 3 clinical trial titled A Phase 3, Multi-Site, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of eRapa to Improve Clinical Outcomes in Patients With Familial Adenomatous Polyposis aims to evaluate the efficacy of eRapa in slowing disease progression in patients with Familial Adenomatous Polyposis (FAP). The study seeks to determine if eRapa can reduce the number of polyps, improve quality of life, and ensure safety for patients.
Intervention/Treatment: The trial tests eRapa, an encapsulated form of rapamycin, administered orally at 0.5 mg every other week. The purpose is to assess its effectiveness compared to a placebo in managing FAP symptoms.
Study Design: This interventional study employs a randomized, parallel assignment model with quadruple masking (participant, care provider, investigator, outcomes assessor) to ensure unbiased results. The primary goal is treatment-focused, aiming to improve patient outcomes.
Study Timeline: The study began on April 10, 2025, with primary completion expected soon. The latest update was submitted on September 12, 2025, indicating ongoing recruitment and progress.
Market Implications: This study update could positively influence Biodexa Pharmaceuticals Plc’s stock performance by demonstrating potential advancements in FAP treatment. Success in this trial may enhance investor confidence and position the company favorably against competitors in the pharmaceutical industry.
The study is ongoing, with further details available on the ClinicalTrials portal.