Biodexa Activates First Clinical Site for Phase 3 Serenta Trial in FAP Patients.

Biodexa Pharmaceuticals PLC has activated the first clinical study site for its Serenta trial in patients with familial adenomatous polyposis (FAP). The trial, now enrolling, aims to evaluate the safety and efficacy of eRapa in individuals diagnosed with FAP. The first site, in the US, is open and actively screening eligible participants. This represents a significant milestone in developing a potential new treatment option for FAP.

Biodexa Pharmaceuticals PLC (BDRX) has activated the first clinical study site for its Serenta trial in patients with familial adenomatous polyposis (FAP). The trial, now enrolling participants, aims to evaluate the safety and efficacy of eRapa in individuals diagnosed with FAP. The first site, located in the US, is open and actively screening eligible participants.

The Serenta trial (NCT06950385) is a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of eRapa in FAP patients. The trial is supported by significant funding and regulatory approvals, including a $20 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT), Fast Track Designation, and a positive Type C Meeting.

Biodexa has also launched a dedicated website, serentatrial.com, to provide resources and updates on the trial. The activation of the first clinical study site marks a significant milestone in the development of a potential new treatment option for FAP, 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.

References:
[1] https://www.globenewswire.com/news-release/2025/06/25/3105070/0/en/Biodexa-Announces-Activation-of-First-Clinical-Study-Site-for-Phase-3-Serenta-Trial-in-Familial-Adenomatous-Polyposis-FAP.html
[2] https://www.stocktitan.net/news/BDRX/biodexa-announces-activation-of-first-clinical-study-site-for-phase-56fnenxpb2a2.html
[3] https://www.gurufocus.com/news/2939156/biodexa-unveils-serenta-as-the-name-of-its-upcoming-phase-3-study-in-familial-adenomatous-polyposis-fap-bdrx-stock-news