Biodexa Hits Key Milestone For Its Type 1 Diabetes Candidate Tolimidone, Enrolls First Patient In Phase 2a Study
Rhea-AI Summary
Positive
- Tolimidone showed promising preclinical results, including beta cell proliferation in human cadaver samples
- The drug could potentially become a first-in-class blood glucose modulating agent taken as a pill instead of insulin injections
- Large market opportunity with type 1 diabetes treatment market projected to reach $26.22 billion by 2032
- Drug already has extensive safety data from previous Pfizer trials for different indication
Negative
- Small initial trial size of only 12 patients
- Previous development by Pfizer was discontinued due to lack of efficacy for original indication
- Early stage development (Phase 2a) with no guarantee of success
- Faces competition in a well-established insulin therapy market
News Market Reaction
On the day this news was published, BDRX gained 29.35%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
CARDIFF, UNITED KINGDOM / ACCESS Newswire / June 18, 2025 / When it comes to type 1 diabetes, treating this chronic condition can be difficult. After all, with this type of diabetes, the body's immune system attacks and destroys the beta cells that produce insulin. Without the natural ability to produce insulin, glucose from the bloodstream isn't absorbed into cells to provide energy. Since there is no cure, patients with type 1 diabetes need lifelong insulin therapy, typically via injections or a pump. Although type 1 diabetes typically develops in childhood or adolescence, it can happen at any age and is more likely to occur in individuals who are obese or inactive, or both. 1.7 million adults aged 20 or older - or
As it stands, the global market for treating type 1 diabetes is
Biodexa Believes It Has The Answer
That's why a handful of companies, including Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), a clinical stage biopharmaceutical company developing treatments for unmet medical needs, are working on next-generation drugs and therapies to treat this insidious disease. Biodexa is developing Tolimidone to treat type 1 diabetes and has recently enrolled its first patient in a phase 2a trial.
Tolimidone was first discovered by Pfizer Inc. and was developed to treat gastric ulcers. The drug made it through phase 2 trials, but Pfizer discontinued developing the drug because of a lack of efficacy for gastric ulcers. But for type 1 diabetes, it holds promise given 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. In layman's terms, it can potentially help the body produce insulin. 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.
The use of Tolimidone in type 1 diabetes has been demonstrated in a number of preclinical studies conducted at the University of Alberta. The studies identified Lyn kinase as a key factor for beta cell survival and proliferation in in vitro and in vivo models, reports Biodexa. Very promising, noted the company, is the fact that Tolimidone was able to induce proliferation in beta cells isolated from human cadavers. Biodexa believes the drug has the potential to become a first-in-class blood glucose modulating agent. That would be welcome news to type 1 diabetes patients who are forced to take insulin shots or use an insulin pump. Taking just a pill to manage their disease could prove game changing.
Phase 2a Trial Gets Its First Patient
Currently, Biodexa is working with the University of Alberta on a phase 2a dose confirmation study, and the enrollment of the first person in that study is a big milestone for Biodexa. The dosing study was already approved by Health Canada and will be conducted by the University of Alberta, which 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.
"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 put together by Pfizer, Melior and Bukwang," said Stephen Stamp, CEO and CFO of Biodexa, when the study was first announced. The study is designed to build on the preclinical data that Biodexa said suggested Tolimidone could have a proliferative impact on pancreatic beta cells, the cells responsible for insulin production.
Type 1 diabetes may not be the most common form of diabetes, but it can be among the most life-altering, requiring patients to rely on insulin for the rest of their lives. Biodexa is trying to make that easier for sufferers, taking a drug already developed and putting it to use in another form, one that the company believes holds a lot of potential.
With the first patient enrolled in its phase 2a trial, Biodexa is much closer to bringing relief to type 1 diabetes patients. Stay tuned to hear more about Tolimidone and Biodexa's progress in fighting a disease that impacts millions of people in the U.S. and abroad.
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Contact:
Stephen Stamp, CEO, CFO
ir@biodexapharma.com
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SOURCE: Biodexa Pharmaceuticals
View the original press release on ACCESS Newswire
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