Biodexa Launches Global eRapa Access Program, Prepping Phase 3 Trial Backed by $20 M Grant
Biodexa launched a global early access program for eRapa to treat familial adenomatous polyposis through partnership with Tanner Pharma Group, enabling real-world prescribing outside clinical trials. This initiative precedes a Phase 3 trial enrolling 168 patients at 30 US and European sites, backed by a $20 million CPRIT grant.
1. Global Early Access Program Launched
Biodexa has initiated a global Early Access Program for its investigational oral rapamycin formulation, eRapa, targeting patients with familial adenomatous polyposis. Through a strategic partnership with Tanner Pharma Group, clinicians worldwide can prescribe eRapa outside of clinical trials, subject to local regulations and funding.
2. Phase 3 Trial Design and Enrollment
Following positive Phase 2 data, Biodexa plans a double-blind, placebo-controlled Phase 3 registrational trial across 30 sites in the US and Europe. The study will randomize 168 patients in a 2:1 ratio to eRapa or placebo, with site activation and patient enrollment underway.
3. CPRIT Grant Funding
The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas. This funding will underwrite trial costs, patient monitoring, and regulatory submission activities.
4. Real-World Data Initiative
In parallel with clinical development, Biodexa will collect real-world data from Early Access Program participants to document patient outcomes and daily challenges of FAP. These insights aim to strengthen regulatory filings and inform future market access strategies.