Company: BDRX
Filing Date: 2025-09-12
Form Type: 424B3
Source: 0001214659-25-013675
Chunk: 7

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-09-12
Form: 424B3
Chunk 7
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 (NCT04375813) is fully enrolled at 166 patients with primary endpoints
of safety/tolerability and relapse free survival after 12 months of treatment. The study, which is supported by a $3.0 million non-dilutive
grant from the National Cancer Institute, part of the National Institutes of Health, was transferred to the University of Texas, San Antonio
as an Investigator Initiated Trial and is expected to read out in mid-2026.

MTD228 - Tolimidone

Tolimidone was originally
discovered by Pfizer and was developed through Phase 2 for the treatment of gastric ulcers. Pfizer undertook a broad pre-clinical program
to characterize the pharmacology, pharmacokinetics, metabolism and toxicology of tolimidone. Pfizer discontinued development of the drug
due to lack of efficacy for that indication.

Tolimidone is a selective
activator of the enzyme Lyn kinase which increases phosphorylation of insulin substrate-1, thereby amplifying the signalling cascade initiated
by the binding of insulin to its receptor.

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Type 1 Diabetes (“T1D”)

Tolimidone’s
potential utility in T1D has been demonstrated by several preclinical studies conducted by the University of Alberta, where Lyn kinase
was identified as a key factor for beta cell survival and proliferation in in vitro and in vivo models. Most importantly,
tolimidone appeared to induce proliferation in beta cells isolated from human cadavers. From a mechanism of action perspective, tolimidone
has been shown to both prevent beta cell degradation and to stimulate beta cell proliferation. In a meta analysis of 1,202 articles and
193 studies, the incidence of T1D was shown to be 15 per 100,000 with a prevalence of 9.5 per 10,000 of the population

As a first
step in the continued clinical development of tolimidone, a Phase 2a Investigator Initiated Trial (IIT) at the University of Alberta Diabetes
Institute (NCT06474598) is designed to establish the minimum effective dose of tolimidone in patients with T1D. The study, enrolled the
first patient in June 2025 and is expected to recruit 12 patients initially across three dose groups. The study will measure C-peptide
levels (a marker for insulin) and HbA1c (a marker for blood glucose) after three months compared with baseline and the number