Biodexa Pharmaceuticals Plc announces progress on initiation of a Phase 2a study of tolimidone in Type 1 diabetes (?T1D?). Health Canada has approved a Phase 2a dose confirmation study of tolimidone in T1D. The study will be an Investigator Initiated Trial (IIT) to be conducted by the University of Alberta.

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. The study may be expanded in due course. It is expected the first patient will be enrolled in the current quarter.

Tolimidone was originally discovered by Pfizer Inc. (?Pfizer?) and was developed through Phase II for the treatment of gastric ulcers. Pfizer undertook a broad pre-clinical program to characterize the pharmacology, pharmacokinetics, metabolism and toxicology of tolimidone. Pfizer discontinued development of the drug due to lack of efficacy for that indication in a Phase II clinical trial.

Tolimidone is a selective activator of the enzyme Lyn kinase which increases phosphorylation of insulin substrate -1, thereby amplifying the signalling cascade initiated by the binding of insulin to its receptor. Biodexa plans to develop tolimidone for the treatment of T1D. Tolimidone?s potential utility in T1D has been demonstrated by a number of preclinical studies conducted at the University of Alberta, where Lyn kinase was identified as a key factor for beta cell survival and proliferation in vitro and in vivo models.

Most importantly, tolimidone was able to induce proliferation in beta cells isolated from human cadavers.