Company: BDRX
Filing Date: 2025-09-12
Form Type: 424B3
Source: 0001214659-25-013675
Chunk: 5

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-09-12
Form: 424B3
Chunk 5
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 for organ rejection in renal transplantation as Rapamune®(Pfizer).
Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics
and toxicity generally associated with the currently available forms of rapamycin. eRapa is protected by a number of issued patents which
extend through 2035, with other pending applications potentially providing further protection beyond 2035.

Familial Adenomatous Polyposis (“FAP”)

FAP is an orphan
indication characterized by 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 almost always 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 US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan
Designation in the US and 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.

An open-label
Phase 2 study (NCT04230499) was conducted by Emtora in seven U.S. centres of excellence in 30 adult patients. 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, as measured by the aggregate
of all polyp diameters.

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In May
2024 and June 2024, results of the Phase 2 study at six months and 12 months, respectively, were presented at prestigious scientific meetings
by Carol Burke, MD, the Principal Investigator. In summary, at six months, eRapa appeared safe and