Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 157

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 157
---
Rapa Developments

Our open-label
Phase 2 study was conducted in seven United States centers of excellence in 30 adult patients with a 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 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 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 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