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Biodexa Pharmaceuticals Plc (NASDAQ: BDRX) is a pioneering company in the field of drug delivery technology, dedicated to enhancing the bio-delivery and bio-distribution of medicines. The firm integrates approved and developed medications with its proprietary drug delivery technologies to create impactful products that can significantly improve patients' lives.
One of the core focuses of Biodexa is its innovative biocompatible gold nanoparticles (GNPs) technology, which is designed to target specific cells and tissues, offering precision in treatment. The company's therapeutic pipeline includes promising candidates for diabetes and various cancers. Through its strategic joint venture, MidaSol Therapeutics LP, with MonoSol Rx LLC, Biodexa has been developing MidaForm™ Insulin PharmFilm, an oral insulin delivery system currently in phase II clinical trials.
Recently, Biodexa has made significant strides with its acquisition of eRapa™, a phase 3-ready candidate aimed at treating Familial Adenomatous Polyposis (FAP). This acquisition not only expands Biodexa's portfolio but also brings in a substantial $17 million grant from the Cancer Prevention and Research Institute of Texas to support the phase 3 program. The company aims to begin registrational phase 3 clinical trials in the first quarter of next year, with eRapa showing promising phase 2 results in reducing polyp burden in FAP patients.
Biodexa's robust development pipeline includes three pharmaceutical compounds covering seven indications, six of which are in clinical stages. The company's commitment to innovation is further exemplified by multiple Orphan Drug Designations from the FDA for its products. With an eye on the future, Biodexa continues to leverage strategic partnerships, cutting-edge technology, and non-dilutive funding to deliver transformative therapeutic solutions to unmet medical needs.
For more information, please visit the Biodexa Pharmaceuticals website or contact Stephen Stamp, CEO, and CFO at ir@biodexapharma.com.
Latest News:
- June 3, 2024: Biodexa reports promising phase 2 results for eRapa in treating FAP.
- May 22, 2024: Biodexa announces the acquisition of worldwide rights to eRapa.
- May 21, 2024: Updates on phase 3 trials and financial conditions.
- April 30, 2024: Registrational phase 3 clinical trials for eRapa are expected to start in the first quarter of next year.
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.
Biodexa Pharmaceuticals (NASDAQ:BDRX) is set to start phase 3 clinical trials for eRapa to combat Familial Adenomatous Polyposis (FAP), a precancerous condition leading to colorectal cancer. The acquisition of eRapa, supported by a $17 million grant, marks Biodexa's second portfolio expansion in six months, strengthening its position in the biopharmaceutical industry. The potentially life-changing eRapa could be the first drug to treat FAP, offering hope to patients facing invasive surgeries and lifelong complications.
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