Biodexa Pharmaceuticals Plc is a drug delivery technology company. It is focused on the research and development of medicines for rare cancers, via both in-house programs as well as partnered programs. The firm's proprietary platform drug delivery technologies are Q-Sphera platform is a disruptive polymer microsphere technology, which is used for sustained release at the microscale to prolong and control the release of therapeutics over an extended period of time from weeks to months; Midasolve platform is an innovative nano saccharide technology, which is used to dissolve drugs at the nanoscale so that they can be administered in liquid form directly and locally into tumors; Midacore platform is an edge gold nanoparticle technology, which is used for targeting sites of disease at the nanoscale. The company was founded in 2000 and is headquartered in Cardiff, the United Kingdom.
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- Health Canada has approved the expansion of Biodexa's registrational Phase 3 Serenta trial for familial adenomatous polyposis (FAP) into Canada, adding three to four new clinical centers. - The double-blind, placebo-controlled trial is currently active across 29 centers in the US and five European countries, with 73 of a planned 168 patients enrolled to date. - eRapa, an oral mTOR inhibitor formulation of rapamycin, targets mTOR overexpression in FAP polyps and has received Orphan Drug Designation in the US. - FAP currently has no approved therapeutic option; standard of care remains active surveillance and life-altering surgical resection of the colon and/or rectum.
- Biodexa Pharmaceuticals has obtained exclusive global licensing rights to OPB-171775 (MTX240) from Otsuka Pharmaceutical, a Phase 1-ready molecular glue compound designed to treat gastrointestinal stromal tumors. - MTX240 employs a novel mechanism that brings PDE3a and SLFN12 proteins together to trigger apoptosis in GIST cells, bypassing KIT signaling pathways that cause resistance to current tyrosine kinase inhibitors. - Patient-derived xenograft studies demonstrated dose-dependent anti-tumor efficacy against imatinib and sunitinib resistant GIST models, addressing the significant unmet need for 10-15% of patients who develop TKI resistance. - The licensing agreement includes global commercialization rights except Japan, with composition of matter patents extending through 2037 and potential orphan drug designation benefits.
- Biodexa Pharmaceuticals has enrolled the first patient in a Phase 2 study evaluating tolimidone, a selective Lyn kinase activator, for Type 1 diabetes treatment. - The investigator-initiated trial will assess C-peptide levels and HbA1c markers in 12 patients across three dose groups over three months at the University of Alberta. - Preclinical studies demonstrated tolimidone's ability to promote beta cell survival and proliferation, including inducing proliferation in human cadaver-derived beta cells. - Originally developed by Pfizer for gastric ulcers, tolimidone amplifies insulin signaling cascades and represents a potential first-in-class glucose modulating agent.
- Biodexa Pharmaceuticals' eRapa, a novel formulation of rapamycin, receives FDA Fast Track Designation for treating familial adenomatous polyposis (FAP), addressing a critical unmet medical need. - Phase 2 trial demonstrates promising results with 89% of patients showing non-progression at 12 months and a 29% median reduction in polyp burden in the optimal dosing cohort. - A phase 3 registrational study is planned, targeting approximately 140 high-risk FAP patients with a double-blind, placebo-controlled design.
- MTX110, a novel formulation of panobinostat, demonstrates potential survival benefits in patients with recurrent glioblastoma in the phase 1 MAGIC-1 study. - The MAGIC-1 study assesses the feasibility, safety, and efficacy of MTX110 administered via convection-enhanced delivery in recurrent glioblastoma patients. - Data from the MAGIC-1 study builds on previous findings showing MTX110's potential in treating diffuse midline glioma, a rare pediatric brain tumor. - MTX110 is designed to bypass the blood-brain barrier, potentially exposing brain tumors to higher drug concentrations while reducing systemic toxicity.
- Biodexa Pharmaceuticals' MTX110 demonstrates encouraging progression-free survival (PFS) and overall survival (OS) data in recurrent glioblastoma (rGBM) patients. - The MAGIC-1 Phase 1 study evaluates MTX110's feasibility, safety, and efficacy, showing improved survival rates compared to historical norms for rGBM. - MTX110, combining panobinostat with convection-enhanced delivery (CED), bypasses the blood-brain barrier, potentially enhancing drug concentration at the tumor site. - Early trial results suggest MTX110 may offer a new treatment option for aggressive brain cancers like rGBM and diffuse midline glioma (DMG).
