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Biodexa Pharmaceuticals PLC (BDRX) Enrolls 100 Patients in Phase 3 Trial

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BDRX$0.3919 2.26%

Biodexa Pharmaceuticals PLC (BDRX) reached a recruitment milestone by enrolling 100 patients in its registrational Phase 3 Serenta trial. The study tests the candidate drug eRapa for familial adenomatous polyposis and aims to recruit 168 total subjects. Patients in the trial are randomized on a two-to-one basis to receive either the treatment or a placebo.

The progress helps de-risk execution as enrollment moves toward completion. The program is backed by a $20 million non-dilutive grant from the Cancer Prevention and Research Institute of Texas, which eases near-term funding requirements. In market trading, shares of Biodexa fell 16.73% to $0.3832.

Looking ahead, a pre-specified futility analysis could take place early next year to evaluate program viability. Biodexa aims to achieve database lock around the end of next year to prepare top-line results and determine next regulatory steps.

Key points

  • Biodexa Pharmaceuticals enrolled 100 out of a planned 168 subjects in its Phase 3 Serenta trial.
  • Trial participants are randomized on a 2:1 ratio to receive eRapa or a placebo.
  • A pre-specified futility analysis is slated for early next year, with database lock targeted for late next year.
  • Program execution is supported by $20 million in grant funding from the Cancer Prevention and Research Institute of Texas.
  • Biodexa shares fell 16.73% to $0.3832.

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Questions and answers

How many patients has Biodexa enrolled in its Phase 3 eRapa trial?

Biodexa has enrolled 100 subjects out of a planned total of 168 patients in its Phase 3 Serenta trial.

When are the next major milestones expected for Biodexa's Serenta trial?

A pre-specified futility analysis could occur early next year, and database lock is targeted for near the end of next year.

How is Biodexa funding the Phase 3 Serenta trial?

The program is supported by a $20 million non-dilutive grant from the Cancer Prevention and Research Institute of Texas.