Company: BDRX
Filing Date: 2025-05-01
Form Type: DRS
Source: 0001214659-25-006756
Chunk: 35

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-05-01
Form: DRS
Chunk 35
---
 characterized as a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic
option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of
care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with
a reported incidence of one in 5,000 to 10,000 in the United States and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Designation
in the United States and we plan to seek such designation in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps
– thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.

The results of the Phase 2
study were presented at two leading scientific conferences in the second quarter of 2024. Following a positive end-of-Phase 2 meeting
with the United States Food and Drug Administration, or the FDA, we have requested a Type C meeting with the FDA to finalize the protocol
for a Phase 3 multi-center, double-blind, placebo-controlled study in FAP. The Phase 3 study, which is expected to be registrational,
plans to recruit approximately 168 patients across 30 or more sites, with a primary endpoint being time to a defined progression free
survival event. The study is expected to recruit over 18 months and is supported by a non-dilutive grant of $17.0 million from the Cancer
Prevention and Research Institute of Texas.

NMIBC
refers to tumors found in the tissue that lines the inner surface of the bladder. The most common treatment is transurethral resection
of the bladder tumor followed by intravesical Bacillus Calmette-Guerin with chemotherapy depending upon assessment of risk of recurrence.
NMIBC is the fourth most common cancer in men with an incidence of 10.1 per 100,000 and 2.5 per 100,000 in women. Our ongoing multi-center,
double-blind, placebo-controlled Phase 2 study in NMIBC is expected to enroll up to 166 patients with primary endpoints of safety/tolerability
and relapse free survival after 12 months of treatment. The Phase 2 study, which is supported by a $3.0 million non