Company: BDRX
Filing Date: 2025-06-02
Form Type: 424B3
Source: 0001214659-25-008714
Chunk: 3

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-06-02
Form: 424B3
Chunk 3
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AP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor
like eRapa to treat FAP.

$7.3Bn FAP addressable market opportunity
Based on the lowest estimates of prevalence of 1/10,000 and 1/37,600 in the US and Europe, respectively, the adult populations in each
territory of approximately 258 million and 358 million and the median annual cost of approved non-biologic orphan drugs in the US of $206,176,
the implied combined US / European addressable market for eRapa in FAP is approximately $7.3Bn.

About eRapa

eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus.
Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway
that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. 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. Rapamycin is approved in the US 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. Data from the Phase 2 study showed eRapa to be safe and well-tolerated
with a median 17% reduction in total polyp burden at 12 months compared with baseline and an overall 75% non-progression rate. Patients
in cohort 2 experienced an 89% non-progression rate and 29% median reduction in polyp burden at 12 months compared with baseline. The
dosing given to cohort 2 – daily every other week -- is the dosage regimen to be used in the upcoming registrational Phase 3 study.

1. www.rarediseases.org
2. www.orpha.net
3. Althobaiti et al. https://pmc.ncbi.nlm.nih.gov/articles/PMC9957503/
4. Tian et al., mTOR Signaling in Cancer and mTOR Inhibitors in Solid Tumor Targeting Therapy,
Int J Mol Sci