Biodexa Announces Phase 2a Study of Tolimidone in Type 1 Diabetes Approved by Health Canada
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has received approval from Health Canada for a Phase 2a study of tolimidone in Type 1 diabetes (T1D). This Investigator Initiated Trial, to be conducted by the University of Alberta, will measure C-peptide levels and HbA1c after three months compared to baseline, as well as the number of hyperglycemic events. The study will initially involve 12 patients across three dose groups, with potential for expansion. Enrollment of the first patient is expected in the current quarter. This clinical program builds on existing tolimidone data from Pfizer, Melior, and Bukwang.
- Health Canada approval for Phase 2a study of tolimidone in Type 1 diabetes
- Collaboration with University of Alberta for the clinical trial
- Study will measure key diabetes markers: C-peptide levels and HbA1c
- Potential for study expansion beyond initial 12 patients
- None.
The initiation of a Phase 2a study for tolimidone in Type 1 diabetes (T1D) marks a significant step for Biodexa Pharmaceuticals. This study’s approval by Health Canada is particularly notable as it indicates regulatory confidence in the safety and potential efficacy of the drug, allowing further clinical investigation.
Type 1 diabetes is a chronic condition where the pancreas produces little or no insulin. Tolimidone aims to address this by potentially improving insulin markers like C-peptide levels and HbA1c levels. Monitoring these biomarkers is crucial, as they provide direct insights into the drug's impact on insulin production and blood glucose control, which are critical for managing T1D.
The study will start with a small cohort of 12 patients across three dose groups, which is typical for early-stage trials aimed at confirming dosage safety and preliminary efficacy. If successful, this study could pave the way for larger, more definitive trials. Investors should watch for interim results, as positive data could significantly de-risk the clinical development of tolimidone and potentially drive stock valuation higher.
However, early-stage trials carry substantial risk and unexpected adverse events or lack of efficacy could negatively impact Biodexa’s prospects. Given that T1D remains an area with high unmet medical need, positive outcomes from this trial could attract regulatory incentives and partnerships, potentially enhancing shareholder value.
From a market perspective, the approval of this Phase 2a study highlights Biodexa's strategic focus on high-need therapeutic areas. The T1D market is significant, with a high demand for innovative treatments that can improve patient outcomes. By advancing tolimidone, Biodexa is positioning itself within a lucrative market segment that has both commercial potential and societal impact.
This announcement also reflects positively on the company’s ability to form strategic partnerships, such as the collaboration with the University of Alberta. Such alliances can enhance research capabilities and expedite clinical timelines, which is vital for a small-cap biotech firm. The mention of previous data packages from large pharmaceutical companies like Pfizer adds credibility to the drug's development process.
While the immediate financial impact may be minimal, the long-term implications of successful trial progression could attract investment and strategic partnerships, enhancing Biodexa’s market position. Investors should keep an eye on subsequent trial updates and potential partnerships that could arise from positive trial data.
July 16, 2024
Biodexa Announces Phase 2a Study of Tolimidone in Type 1 Diabetes Approved by Health Canada
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 announces progress on initiation of a Phase 2a study of tolimidone in Type 1 diabetes (“T1D”).
Health Canada has approved a Phase 2a dose confirmation study of tolimidone in T1D. The study will be an Investigator Initiated Trial (IIT) to be conducted by the University of Alberta. The study 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 in due course. It is expected the first patient will be enrolled in the current quarter.
Commenting, Stephen Stamp, CEO and CFO of Biodexa said: ”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 ”.
About Tolimidone
Tolimidone was originally discovered by Pfizer Inc. (“Pfizer”) and was developed through Phase II for the treatment of gastric ulcers. Pfizer undertook a broad pre-clinical program to characterize the pharmacology, pharmacokinetics, metabolism and toxicology of tolimidone. Pfizer discontinued development of the drug due to lack of efficacy for that indication in a Phase II clinical trial. 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.
Biodexa plans to develop tolimidone for the treatment of T1D. Tolimidone’s potential utility in T1D has been demonstrated by a number of preclinical studies conducted at the University of Alberta, where Lyn kinase was identified as a key factor for beta cell survival and proliferation in in vitro and in vivo models. Most importantly, tolimidone was able to induce proliferation in beta cells isolated from human cadavers.
For more information, please contact:
Biodexa Pharmaceuticals PLC |
| Stephen Stamp, CEO, CFO |
| Tel: +44 (0)29 20480 180 |
| www.biodexapharma.com |
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 programs include eRapa™, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer; tolimidone, under development for the treatment of Type 1 diabetes and MTX110, which is being studied in aggressive rare/orphan brain cancer indications.
eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis.
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 tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity.
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.” 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 Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, 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 Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.
FAQ
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