Company: BDRX
Filing Date: 2025-11-03
Form Type: 424B3
Source: 0001214659-25-015743
Chunk: 3

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-11-03
Form: 424B3
Chunk 3
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, Netherlands
and Spain with Italy expected to be added in due course.

The U.S. component of the trial enrolled its first
patient in mid-August 2025.

Commenting, Dr Gary Shangold, Chief Medical Officer
of Biodexa, said “Approval of our CTA by EMA is the latest in a series of important milestones for our eRapa Phase 3 program in FAP. We expect to accelerate recruitment by opening sites initially in four European countries. Thanks to the combined efforts of our team, our collaborators at Emtora Biosciences and our European CRO, Precision for Medicine”.

“The opening of our Phase 3 program in FAP in Europe further advances our potential to be the first mover in a $7Bn addressable market,” noted Stephen Stamp, Biodexa’s
CEO and CFO. An approved pharmaceutical treatment for FAP is long overdue. Our goal for eRapa is to meet that need with a treatment that provides FAP sufferers a better quality of life and substantially reduces or eliminates their need for repetitive surgeries.”

The Serenta trial (NCT06950385) is a randomized,
double-blind, placebo-controlled Phase 3 registrational study designed to evaluate the safety and efficacy of eRapa in patients diagnosed
with FAP. Multiple sites in the US are actively screening eligible participants. It is expected that 168 patients will be recruited into
the trial randomized 2:1 drug: placebo.

For more information about the Serenta trial,
including eligibility criteria and specific site location, please visit https://serentatrial.com/.

About FAP

Familial adenomatous polyposis is a rare, inherited
disorder characterized by the development of hundreds to thousands of colorectal polyps and a near-100% lifetime risk of colorectal cancer
if left untreated. There is a significant unmet need for effective, less invasive therapies for FAP patients. FAP is characterized as
a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating
FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated,
FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported prevalence
of one in 5,000 to 10,000 in the US and one in 11,300 to