• 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, United Kingdom, February 7, 2024 (GLOBE NEWSWIRE) -- Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”)(Nasdaq: BDRX), 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, today 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.

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 signalling 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. (“Pfizer”) 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.

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About Biodexa Pharmaceuticals PLC

Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programmes include tolimidone, under development as a novel agent for the treatment of type 1 diabetes and MTX110, which is being studied in aggressive rare/orphan brain cancer indications.

Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent.

MTX110 is a solubilised  formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at  chemotherapeutic doses directly to the site of the tumour, by-passing the blood-brain barrier and potentially avoiding  systemic toxicity.

Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com.

Forward Looking Statements

Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States.  Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation.  All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Examples of forward-looking statements include, among others, statements we make regarding our pre-clinical data and clinical trials. Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.

Reference should be made to those documents that the Company shall file from time to time or announcements that may be made by the Company in accordance with the rules and regulations promulgated by the United States Securities and Exchange Commission, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements.  These forward-looking statements speak only as of the date of this announcement.  All subsequent written and oral forward-looking statements by or concerning the Company are expressly qualified in their entirety by the cautionary statements above.  Except as may be required under relevant laws in the United States, the Company does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.