Biodexa Asset Offers Potential to ‘Radically Improve’ Treatment for Diabetes Patients

Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has entered into an agreement for the rights to develop and commercialize tolimidone under an exclusive, worldwide license from Melior Pharmaceuticals I, Inc. Biodexa plans to develop tolimidone for the treatment of Type-1 diabetes (T1D). The company’s share price rose more than 100%following the news.

Stephen Stamp, CEO and CFO of Biodexa, said, “Tolimidone offers the exciting potential to radically improve disease management for millions of Type-1 diabetes patients. We are eager to initiate a Phase II clinical programme as expeditiously as possible to deliver a positive impact on those patient’s lives. For Biodexa, we believe this deal will significantly strengthen and diversify our pipeline offering existing and new investors greater opportunities for value creation.”

Highlights 

Tlimidone is Phase II-ready with encouraging signals of β cell proliferation in preclinical models, and an extensive safety database.

Biodexa intends to conduct a Phase Ib dose confirmation study in conjunction with the Alberta Diabetes Institute at the University of Alberta to establish the minimum effective dose of tolimidone in patients with T1D.

The Phase II study is expected to be a double-blind, placebo-controlled study of approximately 35 patients with T1D over a period of four months with C-peptide levels as primary end-point. C-peptide is known to correlate with insulin levels in the body.

Tolimidone was originally discovered by Pfizer and was developed through Phase II for the treatment of gastric ulcers, but discontinued due to lack of efficacy for that indication in a Phase II clinical trial.

Tolimidone’s potential utility in T1D has been demonstrated by several ground-breaking studies where lyn kinase was identified as a key factor for beta cell survival and proliferation in in vitro and in vivo models.

T1D and Type 2 diabetes both occur when the body cannot produce sufficient levels of insulin, the hormone essential for regulating glucose levels in the blood.

About Biodexa Pharmaceuticals PLC

Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of products aimed at primary and metastatic cancers of the brain.  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.