Biodexa's Phase 2a Study of Tolimidone in Type 1 Diabetes Approved by Health Canada

On July 16, 2024, Biodexa Pharmaceuticals PLC, a clinical-stage biopharmaceutical company, announced that Health Canada has approved a Phase 2a study of tolimidone for Type 1 diabetes (T1D). The study will be conducted by the University of Alberta and will be an Investigator Initiated Trial (IIT). The aim is to measure C-peptide levels, which indicate insulin levels, and HbA1c, a marker for blood glucose, over a period of three months compared to baseline values. Additionally, the study will track the number of hyperglycemic events in 12 patients across three different dosage groups. An expansion of the study is possible in the future, and the first patient enrollment is expected within the current quarter.

Stephen Stamp, CEO and CFO of Biodexa, expressed enthusiasm about the new clinical program in collaboration with the University of Alberta. He emphasized the importance of the extensive data on tolimidone compiled by Pfizer, Melior, and Bukwang.

Tolimidone was originally discovered by Pfizer Inc. and was initially developed for treating gastric ulcers. Despite a comprehensive pre-clinical program that characterized its pharmacology, pharmacokinetics, metabolism, and toxicology, Pfizer halted its development due to a lack of efficacy in a Phase II clinical trial for gastric ulcers. Tolimidone is a selective activator of the enzyme Lyn kinase, which increases the phosphorylation of insulin substrate-1. This process amplifies the signaling cascade initiated by the binding of insulin to its receptor.

Biodexa plans to develop tolimidone specifically for treating T1D. Preclinical studies conducted at the University of Alberta have shown that Lyn kinase is crucial for the survival and proliferation of beta cells in both in vitro and in vivo models. Notably, tolimidone has been able to induce proliferation in beta cells isolated from human cadavers, demonstrating its potential utility in T1D.

Biodexa Pharmaceuticals PLC is a clinical-stage biopharmaceutical company listed on NASDAQ under the ticker symbol BDRX. The company focuses on developing innovative products for diseases with unmet medical needs. Apart from tolimidone for T1D, Biodexa’s lead development programs include eRapa™ for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, and MTX110 for aggressive rare/orphan brain cancer indications.

eRapa is a proprietary oral tablet formulation of rapamycin (sirolimus), an mTOR inhibitor. The mTOR pathway is significant in regulating cellular metabolism, growth, and proliferation and is often activated during tumorigenesis.

Tolimidone, an orally delivered, potent, and selective inhibitor of Lyn kinase, helps control blood glucose levels by enhancing insulin sensitivity. Lyn kinase is a member of the Src family of protein tyrosine kinases, which is expressed mainly in hematopoietic cells, neural tissues, liver, and adipose tissue. Animal studies have demonstrated its potential as a first-in-class blood glucose modulating agent.

MTX110 is a solubilized formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This formulation allows for direct delivery of therapeutic doses to the tumor site via convection-enhanced delivery (CED), bypassing the blood-brain barrier and potentially reducing systemic toxicity.

Biodexa’s headquarters and R&D facility are located in Cardiff, UK. The company is committed to advancing its pipeline of innovative therapeutics to address unmet medical needs.