Biodexa enrolls 87 patients in Phase 3 FAP trial

• Biodexa reported that 87 of 168 planned patients have been enrolled in its Phase 3 Serenta trial of eRapa in Familial Adenomatous Polyposis.
• The registrational study has exceeded its halfway recruitment target and is active across 29 clinical sites.
• Biodexa’s Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas.

Biodexa (NASDAQ:BDRX) announced that 87 of a planned 168 subjects have been enrolled in its registrational Phase 3 Serenta trial evaluating eRapa in Familial Adenomatous Polyposis (FAP).

The double-blind, placebo-controlled study is recruiting patients across 29 clinical sites in the United States and five European countries, with three additional Canadian sites expected to open.

The trial is designed to randomize patients in a 2:1 ratio of eRapa to placebo and will conduct a futility analysis after 25 Progression Free Survival events, with database lock planned after 75 PFS events.

Biodexa continues the Phase 3 Serenta trial with recruitment exceeding the halfway target.

The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas, while eRapa is an oral mTOR inhibitor formulation of rapamycin.

eRapa has received Orphan Drug Designation in the United States and Europe for Familial Adenomatous Polyposis, a hereditary condition associated with increased colorectal cancer risk.