Biodexa enrolls first patient in type 1 diabetes drug trial

CARDIFF - Biodexa Pharmaceuticals PLC (NASDAQ:BDRX) has enrolled the first patient in a Phase 2a clinical trial for Tolimidone, a drug being investigated as a potential treatment for type 1 diabetes, according to a company press release. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though its current market capitalization stands at just $2.3 million.

The trial, approved by Health Canada and conducted by the University of Alberta, will measure C-peptide levels and HbA1c after three months compared to baseline across three dose groups initially involving 12 patients. The study may be expanded later. InvestingPro analysis indicates the company is quickly burning through cash, with negative free cash flow of $15.36 million in the last twelve months.

Tolimidone, originally discovered by Pfizer Inc. for treating gastric ulcers but later discontinued due to lack of efficacy for that condition, is a selective activator of the enzyme Lyn kinase. This enzyme increases phosphorylation of insulin substrate-1, potentially enhancing insulin signaling.

Preclinical studies conducted at the University of Alberta identified Lyn kinase as a key factor for beta cell survival and proliferation. The company reports that Tolimidone demonstrated ability to induce proliferation in beta cells isolated from human cadavers.

"We are excited to initiate our clinical program in type 1 diabetes with the University of Alberta and build on the extensive tolimidone data package," said Stephen Stamp, CEO and CFO of Biodexa.

Type 1 diabetes affects approximately 1.7 million adults in the United States, or 5.7% of U.S. adults, who require insulin via injections or pumps. The global market for treating type 1 diabetes is currently $16.97 billion and projected to reach $26.22 billion by 2032.

If successful, Tolimidone could potentially offer an alternative to insulin injections or pumps for managing the condition, though further clinical testing will be required to determine its efficacy and safety.

In other recent news, Biodexa Pharmaceuticals PLC has announced several developments that may interest investors. The company has secured an additional $3 million grant from the Cancer Prevention & Research Institute of Texas to support the Phase 3 program of its drug candidate eRapa, aimed at treating familial adenomatous polyposis. This brings the total funding from CPRIT to $20 million for the Phase 3 study, which involves 168 patients across the U.S. and Europe. Additionally, the European Commission has awarded Orphan Drug Designation to eRapa, facilitating its development for this rare condition.

In corporate actions, Biodexa has adjusted the nominal value of its ordinary shares from £0.00005 to £0.000001, following shareholder approval. Shareholders also approved resolutions granting directors the authority to allot ordinary shares on a non-pre-emptive basis. Furthermore, the company has reduced the exercise price of certain outstanding warrants to $0.31 per share, resulting in the issuance of 200,433 American depositary shares. These shares will account for approximately 7.5% of the company’s issued ADSs.

These developments reflect the company’s ongoing efforts to advance its drug pipeline and optimize its financial structure.

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