Biodexa Pharmaceuticals plc reports news on a clinical-stage biopharmaceutical pipeline focused on gastrointestinal cancers, rare diseases and other unmet medical needs. The company’s programs include eRapa for familial adenomatous polyposis and non-muscle invasive bladder cancer, MTX240, a molecular glue candidate for gastrointestinal stromal tumors, and tolimidone for type 1 diabetes.
Recurring developments cover clinical development, regulatory and trial authorizations, manufacturing and access partnerships, licensing, annual results, financing activity, ADR program matters and patient-advocacy initiatives. Biodexa’s American depositary shares trade under BDRX, while company updates may also describe ordinary-share and ADR mechanics for the U.K. issuer.
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has released its audited preliminary financial results for the fiscal year ending December 31, 2024. The company, which positions itself as an acquisition-focused clinical stage biopharmaceutical company, is developing a pipeline of innovative products targeting diseases with unmet medical needs.
Biodexa Pharmaceuticals (Nasdaq: BDRX) announced successful results from its Type C meeting with the FDA regarding the Phase 3 protocol for eRapa in familial adenomatous polyposis (FAP). The meeting focused on statistical planning, safety database, and composite endpoint discussions for the Phase 3 study.
The upcoming Phase 3 trial will be a double-blind placebo-controlled study involving 168 patients, with a 2:1 drug/placebo randomization ratio, conducted across approximately 30 clinical sites in the US and Europe. The study is substantially funded by a $17.0 million CPRIT grant and an $8.5 million Company match, which has been placed in escrow.
This development follows successful Phase 2 data presentations at Digestive Disease Week (May 2024) and InSight Barcelona (June 2024). LumaBridge will manage the US component, while Precision for Medicine will oversee the European segment.
Biodexa Pharmaceuticals (Nasdaq: BDRX) has appointed Precision for Medicine, as the clinical research organization (CRO) for the European component of its upcoming Phase 3 study of eRapa in Familial Adenomatous Polyposis (FAP). The U.S. component will be managed by LumaBridge in San Antonio, Texas.
The Phase 3 registrational study is designed as a double-blind placebo-controlled trial involving 168 patients, with a 2:1 drug/placebo randomization ratio. The study will be conducted across approximately 30 clinical sites in the US and Europe, with initiation planned for next quarter.
Precision, specializing in rare diseases, brings over 20 years of experience with 333 clinical trials in rare diseases and employs more than 700 team members across 11 European locations.
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 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) 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.