Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 159

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 159
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 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 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-progression
rate. The 89% non-progression rate and 29% median reduction in polyp burden in Cohort 2 is likely to be the preferred dosage regimen for
Phase 3.

| 80 |

Tolimidone Developments

On July 16, 2024, we announced Health Canada had
approved a Phase 2a