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5 days ago
Biodexa Hits Key Milestone For Its Type 1 Diabetes Candidate Tolimidone, Enrolls First Patient In Phase 2a Study
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 5.7% of U.S. adults - have the disease and are receiving insulin via shots or a pump.
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.
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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.
Featured image from Shutterstock.
This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice.
Click here for more information on Biodexa Pharmaceuticals.
Contact:
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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1 month ago
Biodexa Announces Award of Additional $3.0M Grant from CPRIT to Support Registrational eRapa Phase 3 Program in FAP Brings Total CPRIT Grant Funding for eRapa Phase 3 Program to $20.0M
May 22, 2025
Biodexa Announces Award of Additional $3.0M Grant from CPRIT to Support Registrational eRapa Phase 3 Program in FAP
Brings Total CPRIT Grant Funding for eRapa Phase 3 Program to $20.0M
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, today announced its collaboration partner, Rapamycin Holdings, Inc. d/b/a Emtora Biosciences (“Emtora”) has been awarded an additional grant of $3.0 million from the Cancer Prevention & Research Institute of Texas (“CPRIT”). This award brings the total grant awarded by CPRIT to support the registrational Phase 3 program of eRapa in familial adenomatous polyposis (“FAP”) to $20.0 million.
”We are sincerely thankful to Emtora, our collaboration partner for their work in preparing the application and, of course, to CPRIT for this additional award.” said Stephen Stamp, CEO and CFO of Biodexa Pharmaceuticals PLC. “This grant will enable us to include more sites, speed up recruitment and, subject to regulatory approval, bring this medicine to patients who currently have no option other than surgical resection of part or all of their GI tract.”
The Cancer Prevention and Research Institute of Texas
To date, CPRIT has awarded $2.9 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 237 distinguished researchers, supported the establishment, expansion or relocation of 43 companies to Texas and generated over $5.7 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.4 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment to provide an additional $3 billion to CPRIT for a total $6 billion investment in cancer research and prevention. Learn more at https://cprit.texas.gov/.
eRapa Phase 3 program
The Phase 3 study of eRapa in FAP is in the final stages of implementation. It will be a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo. It is expected the study will be conducted in approximately 30 clinical sites across the US and Europe. The US component of the study will be conducted by LumaBridge, based in San Antonio, Texas and the European component will be conducted by Precision for Medicine LLC. All planned US sites and the majority of European sites have been identified. Recruitment is expected to begin in the next few weeks.
About FAP
FAP is characterized as a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported prevalence of one in 5,000 to 10,000 in the US1 and one in 11,300 to 37,600 in Europe2. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.
$7.3Bn FAP addressable market opportunity
Based on the lowest estimates of prevalence of 1/10,000 and 1/37,600 in the US and Europe, respectively, the adult populations in each territory of approximately 258 million and 358 million and the median annual cost of approved non-biologic orphan drugs in the US of $206,1763, the implied combined US / European addressable market for eRapa in FAP is approximately $7.3Bn.
About eRapa
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 tumorgenesis4. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune®(Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. Data from the Phase 2 study showed eRapa to be safe and well-tolerated with a median 17% reduction in total polyp burden at 12 months compared with baseline and an overall 75% non-progression rate. Patients in cohort 2 experienced an 89% non-progression rate and 29% median reduction in polyp burden at 12 months compared with baseline. The dosing given to cohort 2 – daily every other week -- is the dosage regimen to be used in the upcoming registrational Phase 3 study.
1. www.rarediseases.org
2. www.orpha.net
3. Althobaiti et al. https://pmc.ncbi.nlm.nih.gov/articles/PMC9957503/
4. Tian et al., mTOR Signaling in Cancer and mTOR Inhibitors in Solid Tumor Targeting Therapy, Int J M
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3 months ago
With Fast Track Designation in Hand, a Successful Protocol Discussion with FDA, and CROs in Place, Biodexa is on Track to Initiate its Funded Phase 3 Trial in FAP Next Quarter
CARDIFF, UNITED KINGDOM / ACCESS Newswire / March 19, 2025 / Biodexa Pharmaceuticals PLC. (NASDAQ:BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is making progress in readying the launch of a phase 3 trial for eRapa, its proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP).
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In just the last few weeks, Biodexa received Fast Track designation from the FDA, conducted a successful Type C (pre-Phase 3 protocol finalization) meeting with the FDA and appointed a clinical research organization (CRO) to conduct the European component of its registrational Phase 3 trial. A CRO for the U.S. component was appointed earlier.
FAP is an inherited condition that puts people at a much greater risk of developing colon cancer. With FAP, hundreds or thousands of precancerous polyps grow throughout the gastrointestinal tract. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. People with FAP, which usually appears in the patient's mid-teens, end up eventually having their entire colon removed. If left untreated there is a high likelihood the person will develop colon or rectum cancer.
Biodexa hopes to help with eRapa, a proprietary oral tablet formulation of rapamycin, also known as sirolimus, which slows down the mTOR (mammalian Target Of Rapamycin) protein.
"Too much mTOR has been linked to cancer and has been shown to be over-expressed in FAP polyps - thereby underscoring the rationale for using an mTOR inhibitor like eRapa to treat FAP", noted Stephen Stamp, Biodexa's CEO and CFO.
Phase 3 Study Commencing Next Quarter
Biodexa, which has already received Fast Track designation by the FDA for the drug, completed a successful Phase 2 trial of eRapa, demonstrating a 17% median decrease in overall polyp burden and an overall non-progression rate of 75%. Biodexa said patients in cohort 2, the dosage regimen that will be used in Phase 3, experienced an 89% non-progression rate and 29% median reduction in polyp burden at 12 months compared with baseline.
The Phase 3 study will be a double-blind placebo-controlled design recruiting approximately 168 high-risk patients diagnosed with germline or phenotypic FAP. It is expected the study will be conducted in about 30 clinical sites across the U.S. and Europe.
That Phase 3 trial is getting closer to a launch following on the heels of what the company says was a successful Type C meeting with the FDA. During the meeting with FDA representatives from both the gastroenterology and oncology divisions, Biodexa and the FDA discussed the company's statistical plan, the safety database and a composite endpoint for the Phase 3 study. As a result of that meeting, Biodexa believes it has a clear path forward for the initiation of the U.S. Phase 3 study next quarter.
"With no approved products for FAP, we were pleased to collaborate with FDA and our U.S. CRO, LumaBridge, to define the regulatory pathway for eRapa in FAP," said Gary Shangold, MD, Chief Medical Officer of Biodexa. "Agreement on the composite endpoint, in particular, clears the path to finalize the protocol, recruit the U.S. sites and begin patient enrollment."
The Phase 3 program is substantially funded by a $17 million grant from the Cancer Prevention Research Institute of Texas, which has been matched 1:2 by Biodexa contributions of $8.5 million for a total funding of $25.5 million.
U.S. and European CROs On Board
Biodexa previously appointed LumaBridge to conduct the study in the U.S. and just tapped Precision for Medicine as the CRO to conduct the European component of the upcoming registrational Phase 3 study of eRapa in FAP.
LumaBridge was founded in 2014 to help advance the development of novel immunotherapies in the fight against cancer. Building on the founders' 3 decades of combined experience in academic and military research, LumaBridge offers full outsourced clinical trial support across the entire timeline of clinical development, including consultation on clinical development strategy, as well as special capabilities in military research. Over the 11 years since its founding, LumaBridge has made a significant impact in the advancement of immuno-oncology therapies, supporting a substantial number of trials and projects for over 30 clients.
Precision for Medicine is focused on rare diseases and has a stated mission to accelerate the pathway for complex drug development. Precision for Medicine has been conducting studies for over twenty years and according to Biodexa is known for its high-caliber, therapeutically specialized staff, experienced scientists and physicians, advanced specialty laboratories and problem-solving capabilities. Precision for Medicine has conducted 333 clinical trials in rare diseases and employs over 700 team members in Europe across 11 locations, Biodexa shared in a press release.
With thousands of new cases of FAP each year, people in Europe and America suffering from this disease need relief. Biodexa is aiming to deliver that, and with its phase 3 study about to get underway, that may happen sooner rather than later.
Featured photo by National Cancer InstituteonUnsplash.
This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice.
Click here for more information on Biodexa Pharmaceuticals.
Contact:
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.
SOURCE: Biodexa Pharmaceuticals PLC
View the original press release on ACCESS Newswire
https://app.accessnewswire.com/img.ashx?id=1001827
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3 months ago
Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP
March 10, 2025
Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP
Clears the way to finalize Phase 3 protocol and recruit sites for U.S.
Phase 3 substantially funded by $17.0 million CPRIT grant and $8.5 million Company match
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, today announced the results of its Type C meeting with the U.S. Food and Drug Administration (“FDA”) regarding the protocol for the planned registrational Phase 3 study of eRapa in familial adenomatous polyposis (“FAP”).
The Type C meeting followed a productive End of Phase 2 meeting with FDA and the publication of Phase 2 data of eRapa in FAP at six months at Digestive Disease Week in May 2024 and 12 months data at InSight, Barcelona in June 2024. The Type C meeting included a discussion of the statistical plan, the safety database and, most importantly, a composite endpoint for the Phase 3 study. FDA representatives from both Gastroenterology and Oncology Divisions provided valuable input into the proposed program and the Company believes there is a clear path forward for initiation of the registrational Phase 3 study in FAP in the U.S. next quarter.
The planned registrational Phase 3 study of eRapa in FAP will be a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo. It is expected the study will be conducted in approximately 30 clinical sites across the US and Europe. The US component of the study will be conducted by LumaBridge, based in San Antonio, Texas and the European component will be conducted by Precision for Medicine LLC. The Phase 3 study is supported by a $17.0 million grant from the Cancer Prevention Research Institute of Texas (“CPRIT”) and a Company match of $8.5 million which has already been paid, in full, into escrow.
Commenting, Dr Gary Shangold, Chief Medical Officer of Biodexa, said, “With no approved products for FAP, we were pleased to collaborate with FDA and our US CRO, LumaBridge, to define the regulatory pathway for eRapa in FAP. Agreement on the composite endpoint, in particular, clears the path to finalize the protocol, recruit the U.S. sites and begin patient enrolment”
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4 months ago
Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis
February 10, 2025
Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis
Underscores unmet need for a therapeutic alternative with the potential to delay or prevent surgical removal of the colon and/or rectum
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, announced today that the US Food and Drug Administration (“FDA”) has granted Fast Track designation for eRapa, a proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP). Fast track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
The designation was requested based on the potential for eRapa to address an unmet medical need for FAP, a condition which left untreated universally leads to colorectal cancer. Today, the only treatment option is surgical resection of the colon and/or rectum. Data from the Phase 2 study of eRapa in FAP showed eRapa to be safe and well-tolerated with a median 17% reduction in total polyp burden at 12 months compared with baseline and an overall 75% non-progression rate. Patients in cohort 2 experienced an 89% non-progression rate and 29% median reduction in polyp burden at 12 months compared with baseline. The dosing given to cohort 2 – daily every other week -- is the preferred dosage regimen for the upcoming registrational Phase 3 study.
eRapa in FAP
FAP is characterized as a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP universally leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported prevalence of one in 5,000 to 10,000 in the US1 and one in 11,300 to 37,600 in Europe2. Biodexa has received US FDA Orphan Drug designation for eRapa in FAP and plans to seek a