Company: BDRX
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001214659-25-016821
Chunk: 44

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-11-17
Form: F-1
Chunk 44
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 announced
that the FDA had granted fast track designation for eRapa. Fast track designation is intended to facilitate the development and expedite
the review of drugs to treat serious conditions and fill an unmet medical need.

Tolimidone. Tolimidone
was originally discovered by Pfizer Inc., or 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 in Phase 2. Tolimidone is a selective activator of the enzyme Lyn
kinase which increases phosphorylation of insulin substrate -1, thereby amplifying the signaling cascade initiated by the binding of insulin
to its receptor.

We intend to develop tolimidone
for the treatment of T1D. As a lyn kinase activator, tolimidone has been shown in preclinical experiments to have a role in beta cell
survival and proliferation. If replicated in clinical studies, tolimidone could have the potential to be disease modifying and change
the treatment paradigm for T1D. T1D affects approximately 8.4 million people worldwide and there are approximately 500,000 new diagnoses
per annum.

As a first step in the planned
continued clinical development of tolimidone, we intend to initiate a Phase 2a dose confirmation study to establish the optimum dose of
tolimidone in patients with T1D. The Phase 2a study will be open-label in approximately 12 patients with T1D treated over a period of
three months with endpoints of change in C-peptide levels, HbA1c and number of hyperglycemic events. On June 4, 2025, we announced the
recruitment of the first patient in the study.

MTX110. Using
our MidaSolve technology in combination with panobinostat, an otherwise insoluble drug and one that we believe is among the most effective
agents, MTX110 is designed for direct-to-tumor treatment of intractable brain cancers. Panobinostat is currently marketed under the brand
Farydak® which is used orally in combination therapy for the treatment of multiple myeloma. We are currently researching the utility
of MTX110 to proof-of-concept stage in three indications:

Glioblastoma Mult