Positive Statistically Significant Phase 2 Clinical Trial Results of Biodexa’s Newly-licensed eRapa in Familial Adenomatous Polyposis (FAP) Scheduled for Presentation at the 2024 Digestive Disease Week Annual Meeting

May 21, 2024

Biodexa Pharmaceuticals PLC
(“Biodexa” or the “Company”)

Positive Statistically Significant Phase 2 Clinical Trial Results of Biodexa’s Newly-licensed eRapa in Familial Adenomatous Polyposis (FAP) Scheduled for Presentation at the
2024 Digestive Disease Week Annual Meeting

Overall 83% non-progression rate at 6 Months

Statistically Significant decrease in overall mean polyp burden at 6 months (p=0.04)

Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce that results of a Phase 2 clinical trial of eRapa in Familial Adenomatous Polyposis (“FAP”) (NCT04230499) are scheduled for presentation at the prestigious 2024 Digestive Disease Week annual meeting in Washington D.C.. Carol Burke, MD, the Principal Investigator, will present the six month data in a podium presentation at the meeting.

The study was partially supported by $20M in grant funding from the Cancer Prevention and Research Institute of Texas under product development awards DP22053 and DP190069.

Design of the Phase 2 study
The open-label study was conducted in seven U.S. centers of excellence in 30 adult patients with median age of 43 years with intact colon (n=6) or post-colectomy and ileo-rectal anastomosis and at least 10 adenomas in the rectal remanent (n=24).

Patients were sequentially enrolled into three dosing cohorts of 10 patients each for a 12-month treatment period: 0.5mg every other day (Cohort 1), 0.5mg daily every other week (Cohort 2), and 0.5mg daily (Cohort 3). Upper and lower endoscopic surveillance occurred at baseline and after six months. Primary endpoints were safety and tolerability of eRapa and percentage change from baseline in polyp burden at six months, as measured by the aggregate of all polyp diameters. Polyp outcomes were classified into Progressive Disease (PD: >20% increase in polyp burden), Stable Disease (SD: ± 20% change in polyp burden) or Partial Response (PR: >20% reduction in polyp burden). A combination endpoint of non-progressors included SD and PR.