Company: BDRX
Filing Date: 2025-12-11
Form Type: F-1/A
Source: 0001214659-25-017944
Chunk: 38

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-12-11
Form: F-1/A
Chunk 38
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D 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 Multiforme (GBM):GBM is the most common and aggressive form of brain cancer in adults, usually occurring in the white matter of
the cerebrum. Treatments include radiation, surgical resection and chemotherapy although, in almost all cases, tumors recur. Based on
available date from the American Association of Neurosurgeons, there are approximately 2-3/100,000 population diagnoses of GBM per annum.
Survival with standard of care treatment ranges from approximately 13 months in patient with an unmethylated MGMT gene promotor to approximately
30 months in patients with a highly methylated MGMT gene promotor. Studies show the global GBM treatment market was valued at approximately
$2.46 billion in 2022, with expected growth of 9.7% per annum through 2030.

Following IND approval in
December 2021, we are in the process of recruiting patients in a Phase 1 study to assess the utility of MTX110 in recurrent GBM. The Phase
1 study is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered
by CED via implanted refillable pump and catheter. The study