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.
Biodexa Pharmaceuticals plc (NASDAQ: BDRX) is a clinical-stage biopharmaceutical company whose news flow centers on the clinical and regulatory progress of its lead programs eRapa, tolimidone and MTX110. Company announcements and SEC Form 6-K filings describe ongoing activity in familial adenomatous polyposis (FAP), non-muscle invasive bladder cancer (NMIBC), type 1 diabetes and rare or orphan brain cancers.
Investors following BDRX news can expect regular updates on the Serenta Phase 3 trial of eRapa in FAP, including milestones such as enrollment of the first patients, activation of new clinical sites in the United States and Europe, and approval of a Clinical Trial Application by the European Medicines Agency. Releases also provide context on the FAP disease burden and the lack of approved non-surgical treatment options, which frame the rationale for eRapa’s development.
Biodexa’s news stream also covers pipeline developments beyond FAP. The company reports progress in a Phase 2 study of eRapa in NMIBC, a Phase 2a investigator-initiated trial of tolimidone in type 1 diabetes, and early-stage studies of MTX110 in aggressive brain cancers. Operational updates, such as orphan drug designations, Fast Track designation, and collaborations with organizations like Emtora Biosciences, LumaBridge and Precision for Medicine, feature prominently.
In addition, BDRX news includes corporate and financing events such as equity line agreements, warrant transactions, ADR ratio changes and public offerings of ADS Units and pre-funded units, as detailed in Form 6-K filings. Governance and leadership changes, including board appointments and executive role updates, are also disclosed through press releases. For readers tracking BDRX, this news page offers a consolidated view of clinical milestones, regulatory steps and capital markets activity related to Biodexa’s development programs.
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.
Biodexa Pharmaceuticals PLC (NASDAQ:BDRX) has announced positive 12-month data from its Phase 2 clinical trial of eRapa™ for the treatment of Familial Adenomatous Polyposis (FAP), a condition that significantly increases the risk of colorectal cancer. Presented at the 2024 InSIGHT biannual meeting, results indicate a 17% median reduction in polyp burden and a non-progression rate of 75%. Notably, 89% of patients in Cohort 2 (treated daily on alternate weeks) were deemed non-progressors, with a 29% median reduction in polyp burden.
FAP patients currently undergo continuous surveillance and surgeries, often resulting in complete resection of the colon or rectum. Biodexa aims for eRapa to be the first therapeutic alternative, potentially reducing the need for surgical interventions and improving patients' quality of life. The Phase 3 trial, planned to start soon, will involve 140 high-risk FAP patients and be double-blind placebo-controlled. This trial is partially funded by a $17 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT).
Biodexa Pharmaceuticals PLC announced positive results from a Phase 1 study of MTX110 in treating Diffuse Midline Glioma (DMG), a pediatric brain cancer. Presented at ISPNO 2024, the study showed a median overall survival of 16.5 months across all patients, compared to 10.0 months in a historical cohort.
The study, conducted by Columbia University Irving Medical Center, involved nine patients receiving two 48-hour infusions of MTX110 via convection enhanced delivery (CED) at escalating doses. The treatment was generally well-tolerated with some adverse events related to the infusion process. The study's primary endpoint was to assess safety and maximum tolerated dose, with secondary endpoints including progression-free survival (PFS) and overall survival (OS).
Results highlight the potential of MTX110 in extending survival in DMG patients, setting a favorable comparison to historical data. Further studies are anticipated to confirm these findings and optimize treatment protocols.
Biodexa Pharmaceuticals announced positive 12-month results from its Phase 2 clinical trial of eRapa™ for treating Familial Adenomatous Polyposis (FAP). The study revealed a 75% non-progression rate, with a median 17% reduction in overall polyp burden among participants. Cohort 2, comprising patients on a 0.5mg daily dosage every other week, showed the highest efficacy with an 81% non-progression rate and a 29% reduction in polyp burden. These results were presented at the 2024 InSIGHT meeting in Barcelona. The trial, which involved 30 adult participants across seven U.S. centers, was partially funded by a $3 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT). A Phase 3 study, supported by a $17 million CPRIT grant, is planned to further evaluate eRapa's potential in reducing the need for surgical intervention in FAP patients.
Biodexa Pharmaceuticals (NASDAQ: BDRX) announced that all resolutions proposed at its Annual General Meeting on June 13, 2024, were approved by shareholders. This includes key decisions relating to business strategy, governance, and financial operations. Stakeholders can access the full details of these resolutions on the company's website.
Biodexa Pharmaceuticals announced that they will present 12-month data from a Phase 2 clinical trial of eRapa for Familial Adenomatous Polyposis (FAP) at the InSIGHT 2024 meeting in Barcelona on June 22, 2024.
The trial showed promising results, with significant reductions in polyp burden and high non-progression rates. The six-month data was previously presented at the Digestive Disease Weekly meeting in Washington D.C.
eRapa, an mTOR inhibitor, has received Orphan Designation in the US and plans to seek the same in Europe. The trial demonstrated eRapa to be safe and well-tolerated, with only two Grade 3 Serious Adverse Events reported.
Biodexa Pharmaceuticals (NASDAQ:BDRX) reported promising results from a Phase 2 trial of eRapa, a drug aimed at treating familial adenomatous polyposis (FAP). This genetic condition, which almost always leads to colorectal cancer if untreated, currently has no non-surgical treatments. The trial included 30 adults and showed a statistically significant 24% reduction in polyp burden after six months, with an 83% non-progression rate. The Cancer Prevention Research Institute of Texas (CPRIT) awarded a $17 million grant for a Phase 3 study, requiring a $8.5 million match, of which Biodexa has secured $7 million. The 12-month results of the Phase 2 trial will be presented at the InSIGHT conference in Barcelona on June 19-22, and a Phase 3 trial is planned for early 2025.
Biodexa Pharmaceuticals announced $7 million in gross proceeds from the exercise of Series E and F warrants. The funds will cover the first year of obligations for the eRapa Phase 3 trial in Familial Adenomatous Polyposis (FAP) and unlock $17 million in non-dilutive grant funding. The warrant exercises involved 4,358,322 American Depositary Shares (ADSs) at a reduced price of $1.50 per ADS. The company will issue new unregistered warrants to purchase 6,537,483 ADSs at $2.50 per ADS. These proceeds will advance clinical stage assets and support working capital. Significant data for eRapa in FAP showed a statistically significant decrease in polyp burden and an 83% non-progression rate at six months.
Biodexa Pharmaceuticals (Nasdaq: BDRX) announced positive Phase 2 clinical trial results of its new drug eRapa for treating Familial Adenomatous Polyposis (FAP). The trial, involving 30 adult patients at seven U.S. centers, showed an 83% non-progression rate at six months and a statistically significant 24% reduction in overall mean polyp burden (p=0.04). The study was partially funded by a $20M grant from the Cancer Prevention and Research Institute of Texas. The results will be presented at the 2024 Digestive Disease Week annual meeting. The drug appeared safe and well-tolerated, with 97% of patients remaining on treatment at six months.
Biodexa Pharmaceuticals (NASDAQ: BDRX) has posted its Annual Report for the year ending December 31, 2023, and issued a Notice of Annual General Meeting (AGM) to shareholders. The AGM will be held on June 13, 2024, at the company's offices in Cardiff. Shareholders are provided with information on how to vote by proxy. The company's issued share capital consists of 2,238,225,722 Ordinary Shares with voting rights. Biodexa does not hold shares in treasury, and each American Depositary Share comprises 400 Ordinary Shares.