Biodexa In-licenses MTX240, Secures Oral Rapamycin Patent and Advances Phase 3 eRapa Enrollments
Biodexa completed its 2025 shift to therapeutics, in-licensed MTX240 from Otsuka in February 2026 and secured a US patent for oral rapamycin nanoparticle formulations. It enrolled US and European patients in its Phase 3 Serenta eRapa trial after FDA, EMA approvals, will accelerate recruitment, launching a Phase 1b/2a MTX240 study.
1. Preliminary Results for 2025
Biodexa announced audited preliminary results for the year ended 31 December 2025, marking completion of its transition to a therapeutics-focused pipeline with all lead assets at clinical stage.
2. Pipeline In-License and Patent
In February 2026, the company in-licensed MTX240 from Otsuka Pharmaceutical and secured a US patent covering oral rapamycin nanoparticle formulations designed to enhance bioavailability.
3. Phase 3 Serenta Trial Progress
During 2025, Biodexa advanced its Phase 3 Serenta trial of eRapa in Familial Adenomatous Polyposis, achieving a successful FDA Type C meeting, enrolling the first US patient in August, obtaining EMA approval in November and enrolling the first European patient in December.
4. 2026 Development Priorities
For 2026, Biodexa plans to accelerate global Serenta trial recruitment, complete a bioavailability comparison of eRapa versus Rapamune®, initiate a Phase 1b/2a dose escalation study of MTX240 in GIST and explore additional indications.