Welcome to our dedicated page for Biodexa Pharmaceuticals plc news (Ticker: BDRX), a resource for investors and traders seeking the latest updates and insights on Biodexa Pharmaceuticals plc stock.
About Biodexa Pharmaceuticals PLC
Biodexa Pharmaceuticals PLC (NASDAQ: BDRX) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs. Headquartered in Cardiff, UK, the company is strategically positioned to address critical healthcare challenges through its proprietary drug delivery technologies and a robust pipeline of therapeutic candidates targeting rare and orphan diseases.
Core Business Areas
Biodexa specializes in repurposing proven molecules for new therapeutic indications, minimizing clinical development risks while maximizing potential impact. Its business model revolves around licensing and acquiring promising assets, advancing them through clinical trials, and leveraging partnerships for commercialization. The company’s expertise lies in combining established drugs with cutting-edge delivery platforms to enhance bioavailability, bio-distribution, and therapeutic outcomes.
Pipeline and Key Programs
- eRapa: A proprietary oral formulation of rapamycin designed to inhibit the mTOR protein, which is implicated in tumor growth and progression. eRapa is being developed for Familial Adenomatous Polyposis (FAP), a precancerous condition with no approved therapeutic options. The drug has shown promising results in phase 2 trials, reducing polyp burden and delaying disease progression. With FDA Fast Track status and orphan drug designation, eRapa is poised to enter phase 3 trials, supported by a $17 million grant from the Cancer Prevention and Research Institute of Texas.
- MTX110: A solubilized formulation of panobinostat delivered via convection-enhanced delivery (CED) to target aggressive brain cancers such as recurrent glioblastoma (rGBM) and Diffuse Midline Glioma (DMG). By bypassing the blood-brain barrier, MTX110 delivers high drug concentrations directly to tumors, showing potential to extend survival in these otherwise lethal conditions.
- Tolimidone: A phase 2-ready asset for Type 1 Diabetes, tolimidone activates Lyn kinase to promote pancreatic beta-cell survival and proliferation. This novel approach offers hope for halting or reversing disease progression in a condition with limited therapeutic options.
Proprietary Drug Delivery Technologies
Biodexa’s innovative drug delivery platforms enhance the efficacy and safety of its therapeutic candidates. These technologies enable targeted delivery, improved bioavailability, and reduced systemic toxicity, addressing limitations of conventional treatments. For instance, the company’s use of nanotechnology and pH-sensitive polymers in eRapa ensures consistent pharmacokinetics and bioavailability.
Market Position and Competitive Edge
Biodexa differentiates itself through its acquisition-focused strategy, targeting assets with established safety profiles and strong scientific rationale. By focusing on rare and orphan diseases, the company benefits from regulatory incentives, including market exclusivity and grant funding. Its commitment to addressing unmet needs in oncology, metabolic disorders, and rare diseases positions it as a key player in the biopharmaceutical sector.
Strategic Vision
With a strong emphasis on innovation and collaboration, Biodexa aims to transform itself into a sustainable therapeutics company. Its strategic acquisitions, such as eRapa and tolimidone, underscore its commitment to building a diversified pipeline. The company’s focus on high-impact programs, supported by non-dilutive funding and strategic partnerships, ensures a clear path toward commercialization and long-term growth.
Conclusion
Biodexa Pharmaceuticals PLC combines scientific expertise, innovative technologies, and strategic partnerships to address some of the most pressing challenges in healthcare. With a focus on rare and orphan diseases, the company’s pipeline offers hope to patients with limited treatment options, while its business model ensures sustainable growth and value creation for stakeholders.
Biodexa Pharmaceuticals (Nasdaq: BDRX) has received allowance for U.S. patent application No. 17/391.495, titled 'Oral Rapamycin Nanoparticle Preparations and Use' for its eRapa technology. The patent, exclusively licensed from Rapamycin Holdings (d/b/a Emtora Biosciences) in April 2024, will issue on March 4, 2025, and is expected to expire in March 2034.
The company plans to initiate a Phase 3 registrational study of eRapa in Familial Adenomatous Polyposis (FAP) next quarter. The FDA has already granted orphan drug designation for eRapa in FAP, providing seven years of market exclusivity upon approval in the US. This new patent adds an additional layer of protection for the novel drug formulation as Biodexa explores additional indications.
Biodexa Pharmaceuticals (Nasdaq: BDRX), a clinical stage biopharmaceutical company, has announced its upcoming presentation at the Emerging Growth Conference on February 19, 2025. The company's CEO/CFO, Stephen Stamp, will deliver a live, interactive presentation at 09:40 AM Eastern time for 30 minutes.
The event offers shareholders and the investment community an opportunity to interact with Mr. Stamp in real-time. Participants can submit questions in advance to Questions@EmergingGrowth.com or during the live session. For those unable to attend live, an archived webcast will be available on EmergingGrowth.com and the Emerging Growth YouTube Channel.
Registration is required for attendance and updates through the provided webcast link. Biodexa focuses on developing innovative products for diseases with unmet medical needs.
Biodexa Pharmaceuticals (NASDAQ:BDRX) has received FDA Fast Track status for eRapa, its drug treating familial adenomatous polyposis (FAP), following positive Phase 2 results and Orphan Drug designation. The Phase 2 trial showed promising results with a 17% median decrease in overall polyp burden and 75% non-progression rate. Notably, cohort 2 demonstrated an 89% non-progression rate and 29% median reduction in polyp burden at 12 months.
FAP is an inherited condition affecting 1 in 5,000-10,000 people in the U.S. and 1 in 11,300-37,600 in Europe, leading to a nearly 100% lifetime risk of colorectal cancer. Currently, there are no approved therapeutic options, with surgery being the standard treatment. The upcoming Phase 3 study will be double-blind placebo-controlled, recruiting approximately 168 high-risk FAP patients.
Biodexa Pharmaceuticals (Nasdaq: BDRX) has received FDA Fast Track designation for eRapa, their proprietary encapsulated rapamycin treatment for familial adenomatous polyposis (FAP). This designation aims to expedite development and review of drugs addressing serious unmet medical needs.
The Phase 2 study of eRapa demonstrated promising results with a median 17% reduction in total polyp burden at 12 months and a 75% non-progression rate. Notably, cohort 2 showed even better outcomes with an 89% non-progression rate and 29% median reduction in polyp burden using an alternate-week dosing regimen, which will be used in the upcoming Phase 3 study.
FAP, affecting 1 in 5,000-10,000 people in the US and 1 in 11,300-37,600 in Europe, currently has no approved therapeutic options besides surgical removal of the colon/rectum. eRapa has also received FDA Orphan Drug designation for FAP treatment.
Biodexa Pharmaceuticals (Nasdaq: BDRX) has appointed Dr Gary A. Shangold as Chief Medical Officer with immediate effect. The appointment comes as Biodexa prepares for a global Phase 3 registrational study in FAP. Dr Shangold brings extensive experience in drug development across multiple therapeutic areas, most recently serving as Chief Medical Officer at Enteris BioPharma.
Dr Shangold's background includes roles as Chief Medical Officer and Executive VP of R&D at Xanodyne Pharmaceuticals, where he successfully secured two NDAs, and President & CEO of NovaDel Pharma. He spent approximately 10 years in clinical and regulatory affairs at Johnson & Johnson's R.W. Johnson Pharmaceutical Research Institute. Currently, he also serves as CMO at 3Daughters and is Founder & CEO of InteguRx Therapeutics. Biodexa has engaged Dr Shangold through his consulting company, Convivotech.
Biodexa Pharmaceuticals (NASDAQ: BDRX), a clinical stage biopharmaceutical company, announced that shareholders approved both resolutions at its General Meeting held on November 22, 2024. The approved resolutions will only reduce the nominal (par) value per ordinary share, with no change to the number of outstanding ordinary shares. The complete text of the resolutions can be found in the Notice of the General Meeting on the company's website.
Biodexa Pharmaceuticals (NASDAQ:BDRX) is advancing its transformation from a drug delivery innovator to a therapeutics company, focusing on diabetes and cancer treatments. The company's strategy involves repurposing proven molecules for new indications. Their key product eRapa for familial adenomatous polyposis (FAP) showed promising Phase 2 results with a 29% median decrease in polyp burden and 89% non-progression rate. The Phase 3 study is largely funded through a $25.5 million grant and matching funds. Additionally, Biodexa is developing MTX110 for glioblastoma and tolimidone for Type 1 diabetes, with several clinical milestones expected in the coming months.
Biodexa Pharmaceuticals (Nasdaq: BDRX) has successfully regained compliance with Nasdaq's minimum bid price requirement of $1.00 for continued listing. This follows a notice of non-compliance received on August 27, 2024, and a subsequent exception granted by the Nasdaq Hearings Panel on October 14, 2024. The company will remain under a discretionary panel monitor through February 24, 2025, during which it must promptly report any events that could affect its Nasdaq compliance status.
Biodexa Pharmaceuticals (Nasdaq: BDRX) announces a General Meeting scheduled for November 22, 2024, at 13:00 GMT in Cardiff. The Board proposes two key resolutions: 1) subdividing each issued ordinary share of £0.001 into one ordinary share of £0.00005 and 19 C deferred shares of £0.00005, and 2) adopting new articles of association. The purpose is to lower the par value of ordinary shares to enable share issuance above par value. The company confirms that these changes won't affect the number of outstanding ordinary shares or American Depositary Shares.
Biodexa Pharmaceuticals (NASDAQ:BDRX) has released positive patient updates from its ongoing MAGIC-1 study of MTX110 in recurrent glioblastoma (rGBM). The study is evaluating the feasibility, safety, and efficacy of treating rGBM patients with MTX110, a proprietary combination of water-soluble panobinostat and a convection-enhanced delivery system.
Key findings include:
- Patients #1 and #2 in Cohort A achieved overall survival (OS) of 12 and 13 months, respectively
- Patient #3 has achieved 13 months OS to date, with six months progression-free survival (PFS)
- Patient #4 has not progressed and achieved 12 months PFS and 12 months OS to date
These results are promising, considering the median survival post-recurrence for rGBM is typically 6.5 months. The data builds on earlier trial results with MTX110 in Diffuse Midline Glioma (DMG), suggesting potential for a shift in standard of care for aggressive brain cancers.
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