Biodexa (NASDAQ: BDRX) enrolls 100 patients in registrational Serenta FAP trial

What happened

Biodexa Pharmaceuticals PLC (NASDAQ: BDRX) said 100 patients have enrolled in Serenta, its registrational Phase 3 trial in FAP.

The trial is recruiting at 29 clinical sites across the US and five countries in Europe, with a further two sites in Canada expected to be initiated shortly.

The protocol provides for a pre-specified futility analysis after 25 PFS events and database lock after 75 PFS events.

Biodexa plans to enroll 168 subjects and randomize them 2:1, drug to placebo.

Based on the current rate of PFS event accrual, the company said the futility analysis could take place early next year, with database lock potentially around the end of next year.

The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas.

Key numbers

Metric	Latest	Change	Source
enrolled patients	100 patients		Press release dated October 13, 2026
planned enrollment	168 subjects		Press release dated October 13, 2026
clinical sites	29 clinical sites		Press release dated October 13, 2026
CPRIT grant	$20 million		Press release dated October 13, 2026
futility analysis trigger	25 PFS events		Press release dated October 13, 2026
database lock trigger	75 PFS events		Press release dated October 13, 2026

Read more: Biodexa Pharmaceuticals (BDRX) stock analysis and investment case

Why it matters

OptimistFi's case is that Biodexa is a binary, financing-sensitive pharmaceutical development story, so progress that lands before dilution pressure builds matters.

This filing strengthens that case by showing Serenta has reached the 100-patient mark and by pointing to an earlier path for the next trial gate.

At 100 enrolled patients, Serenta is about 59.5% of the planned 168 subjects, which gives investors a clear recruitment benchmark.

The key caveat is that the program still turns on later PFS-event thresholds, so the timetable remains tied to event accrual.

CPRIT's $20 million grant supports the Phase 3 program and shows the study has outside funding behind it.

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What's next

The next dated checkpoint is the pre-specified futility analysis, which Biodexa said could take place early next year if PFS events keep accruing at the current rate.

Database lock could follow around the end of next year under the same pacing.

Two sites in Canada are also expected to be initiated shortly.

Earlier movement toward those milestones would strengthen the case for Serenta, while slower progress would weaken it.

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