Biodexa announces another Serenta milestone with 100 patients enrolled in its registrational Phase 3 trial in FAP
Globe Newswire•13/10/2026•08:30 ET
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Key Highlights
- ➤100 patients enrolled in Biodexa’s registrational Phase 3 Serenta trial for FAP
- ➤Futility analysis could occur early next year based on current PFS event accrual
- ➤Serenta database lock potentially expected around the end of next year
- ➤Phase 3 trial plans 168 subjects randomized 2:1, drug to placebo
- ➤Biodexa’s Phase 3 program is supported by a $20 million CPRIT grant
Expert Statements
Stephen Stamp, Chief Executive Officer of Biodexa
“Enrolment of the 100th patient represents an important milestone for Serenta and reflects the continued strong recruitment performance across our participating sites. Based on the current rate of PFS event accrual, the pre-specified futility analysis could take place early next year with database lock potentially occurring around the end of next year, both significantly sooner than originally anticipated”
Biodexa announces another Serenta milestone with 100 patients enrolled in its registrational Phase 3 trial in FAP
Update on expected timing of pre-specified futility analysis and database lock
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