Company: BDRX
Filing Date: 2025-12-11
Form Type: F-1/A
Source: 0001214659-25-017944
Chunk: 32

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-12-11
Form: F-1/A
Chunk 32
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 clinical sites across the United
States and Europe. On June 25, 2025, we announced the activation of the first clinical
study site for our Phase 3 clinical study in patients with FAP, which is actively screening
patients. On July 14, 2025, we announced the filing of a Clinical Trial Application, or CTA,
with the European Medicines Agency, or EMA, for the Phase 3 study, which is required to begin
a clinical trial in Europe, and on August 18, 2025, we announced the enrollment of the first
two patients in the Phase 3 study by the Pan American Center for Oncology in San Juan, Puerto
Rico. On November 3, 2025, we announced the approval of the CTA by the EMA for the Phase
3 study in Europe, and on December 1, 2025 we announced the enrollment of the first European
patients into the study.

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. Lyn kinase modulates key intracellular functions such as proliferation, differentiation, apoptosis, migration and metabolism. In fat cells, lyn kinase increases utilization of insulin, thus decreasing blood sugar without having an effect on insulin production. In pancreatic islets, activation of lyn kinase promotes beta cell survival and proliferation, whereas its inhibition leads to cell death, prevents proliferation and precipitates diabetes. We are developing tolimidone for T1D initially in a Phase 2a dose confirming study. On June 4, 2025, we announced the recruitment of the first patient in the study. 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 of hyperglycemic events initially in 12 patients across three dose groups.

MTX110, which is being studied in aggressive rare/orphan brain cancer indications including recurrent glioblastoma, diffuse midline glioma, or DMG, and medulloblastoma, is a liquid formulation of the histone deacetylase, panobinostat. Our proprietary formulation enables delivery of the product via convection-enhanced delivery at potentially chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and avoiding systemic toxicity. We have completed recruitment