Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 19

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 19
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 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 the safety and tolerability of eRapa and percentage change from baseline in polyp burden, as measured by the aggregate
of all polyp diameters.

On May 21,
2024, we announced six month results of the Phase 2 clinical trial of eRapa in FAP, which were presented at the 2024 Digestive Disease
Week annual meeting in Washington D.C. In the duodenum, 14 out of 18 patients, or 78%, were non-progressors, with 11 out of 18 of these
patients, or 61%, with a partial response, or PR. In the colorectum, 25 out of 29 patients, or 86%, were non progressors, including all
with an intact colon; of these, 15 out of 29 patients, or 67%, demonstrated PR, including four with an intact colon. Only two drug-related
Grade 3 serious adverse events, or SAEs, occurred during the trial (with no Grade 4 or 5 SAEs reported), and 97% of patients remained
on treatment at six months. In summary, after six months’ treatment, eRapa appeared safe and well-tolerated with a significant 24%
reduction in the total polyp burden at six months compared with baseline (p=0.04) and an overall 83% non-progression rate.

On June 24,
2024, we announced 12 month results of the Phase 2 clinical trial which were presented at the 2024 InSIGHT bi-annual meeting in Barcelona.
Overall, 21 out of 28 patients, or 75%, were deemed to be non-progressors at 12 months, with a median reduction in polyp burden of 17%.
Over the course of 12 months, there were four related Grade 3 or higher and one related SAE reported during the trial, and a 95% compliance
rate at 12 months. One patient was removed from the trial due to non-compliance. In summary, after 12 months’ treatment, eRapa appeared
safe and well-tolerated with a median 17% reduction in the total polyp burden at 12 months compared with baseline and an overall 75% non-pro