• Biodexa plans to initiate a Phase 2 clinical program of tolimidone in Type 1 diabetes, following several preclinical studies demonstrating its role in beta cell survival
• Safety profile established in prior human studies of more than 700 patients

CARDIFF - Biodexa Pharmaceuticals PLC, a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs including Type 1 diabetes (“T1D”) and rare/orphan brain cancers, announced that the U.S. Patent and Trademark Office allowed U.S. patent application No. 16/546,595 titled “Prevention of Pancreatic Cell Degeneration” which was exclusively licensed to Biodexa by Melior Pharmaceuticals, Inc., along with other patents, in a transaction which closed in December 2023, according to the official website of Biodexa.

Stephen Stamp, CEO and CFO of Biodexa, commented “This soon-to-be-issued patent is expected to provide market exclusivity for tolimidone in the U.S. and underpins our investment thesis in ongoing preclinical studies and an upcoming Phase 2 program in Type 1 diabetes patients which we expect to start in next quarter.”

About tolimidone

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.

Tolimidone’s potential utility in the treatment of T1D has been demonstrated in several preclinical studies in which Lyn kinase was identified as a key factor for beta cell survival in in vitro and in vivo models.

As a first step in the continuing clinical development of tolimidone, Biodexa plans to initiate an open-label Phase 2a dose confirmation study in 2Q24 to establish the preferred dose of tolimidone in patients with T1D. This will be followed by a double-blind, placebo-controlled Phase 2b study. End points of both studies will include C-peptide levels, HbA1c and the number of hyperglycemic events.

Tolimidone was discovered by Pfizer Inc. which developed it through Phase 2 for the treatment of gastric ulcers. Pfizer undertook a broad preclinical program to characterize the pharmacology, pharmacokinetics, metabolism and toxicology of tolimidone. Melior, together with Bukwang Pharmaceutical Co Ltd, subsequently conducted two Phase 2 studies in Type 2 diabetes. The two Phase 2 studies together with Pfizer’s earlier work exposed more than 700 patients to tolimidone, creating an extensive safety data package.