Biodexa announces another Serenta milestone with 100 patients enrolled in its registrational Phase 3 trial in FAP
Biodexa enrolled its 100th patient in the registrational Phase 3 Serenta trial of eRapa in Familial Adenomatous Polyposis, out of a planned 168 subjects across 29 US and European sites. CEO Stephen Stamp said the pre-specified futility analysis (after 25 PFS events) could occur early next year, with database lock (after 75 events) potentially around the end of next year — both significantly sooner than originally anticipated. eRapa holds Orphan Drug Designation in the US and Europe; the program is supported by a $20 million CPRIT grant.
Key figures
- Drug Name
- eRapa (oral rapamycin/sirolimus)
- Phase Of Trial
- Phase 3
- Cprit grant
- $20 million
- Clinical sites
- 29
- Patients enrolled
- 100
- Planned enrollment
- 168
- Database lock pfs events
- 75
- Futility analysis pfs events
- 25
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