Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 163

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 163
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 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 15 patients with
T1D treated over a period of three months with endpoints of change in C-peptide levels, HbA1c and number of hyperglycemic events.

For
additional information regarding tolimidone, see “—Recent Developments—Tolimidone Developments”.

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