Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 160

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 160
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 dose confirmation trial of tolimidone in T1D. The study is an Investigator Initiated Trial to be conducted by the
University of Alberta. The trial 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. The trial may
be expanded in due course.

MTX110 Developments

On October 4, 2024, we announced
an update on progression free and overall survival in our Phase 1 trial of MTX110 in rGBM, also known as the MAGIC-G1 study. At that
time, patients 1 and 2 had deceased, with overall survival since the start of treatment of 12 months and 13 months, respectively. Patients
3 and 4 remained in post-study follow-up. Patient 3 had progression free survival of six months and overall survival of 13 months since
start of treatment. Patient 4 has not yet had confirmed progression and therefore had progression free and overall survival of 12 months
since start of treatment.

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.

Our Strategy

In early 2023, we decided
to re-position the Company as therapeutics (as opposed to drug delivery) company and we began looking for additional assets to complement
our MTX110 programs. The delivery of proof-of-concept clinical data is the primary focus of our business model going forward.

Our proprietary drug delivery
technologies are no longer a key priority for the Company.

Development

Our intention is to build
a balanced portfolio of clinical-stage development assets, ideally with a focus on rare / orphan indications. eRapa was in-licensed in
April 2024 and is being developed for FAP and NMIBC. We expect to begin enrolling a multi-center registrational Phase 3 trial in FAP in
the first half of 2025. The Phase 2 trial in NMIBC is ongoing. Tolimidone, which was in-licensed in December 2023, is a Phase 2 ready
asset which we intend to develop for T1D. MTX110 is currently in Phase 1 development for three rare / orphan brain cancers.

Our aim is to