Biodexa Hits Key Milestone For Its Type 1 Diabetes Candidate Tolimidone, Enrolls First Patient In Phase 2a Study
As it stands, the global market for treating type 1 diabetes is $16.97 billion and projected to reach $26.22 billion by 2032, growing at a CAGR of 6.9% from now until then.
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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This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice.
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Stephen Stamp, CEO, CFO
ir@biodexapharma.com
Important notice, please read: The information and statistical data contained herein may contain forward-looking statements that reflect the company's intentions, expectations, assumptions, or beliefs concerning future events, including, but not limited to, expectations with respect to FDA and other regulatory bodies approval of new products, technology, and product development milestones, the ability of the company to leverage its product development and negotiate favorable collaborative agreements, the commencement of sales, the size of market opportunities with respect to the company's product candidates and sufficiency of the company's cash flow for future liquidity and capital resource needs and other risks identified in the Risk Factor Section of the company's Annual Report and any subsequent reports filed with the SEC. We do not undertake to advise you as to any change in this information. The forward-looking statements are qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the company's research and development programs. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Biodexa Pharmaceuticals PLC to provide investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.
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