Biodexa Activates First European Site for Registrational Phase 3 Serenta Trial in FAP

Rhea-AI Summary

Biodexa (Nasdaq: BDRX) activated the University of Bonn as the first European site for the registrational Phase 3 Serenta trial evaluating eRapa in familial adenomatous polyposis (FAP) on November 24, 2025.

The company said this follows approval of its Clinical Trial Application by the European Medicines Agency and cites collaborators Emtora Biosciences, CRO Precision for Medicine, and a $20 million grant from the Cancer Prevention and Research Institute of Texas. The randomized, double-blind, placebo-controlled Serenta trial (NCT06950385) began US enrollment in August 2025. Nine additional European sites across the Netherlands, Spain, Denmark, and Italy are expected to activate in the next 2–3 months. For eligibility and site details visit https://serentatrial.com/.

Positive

• First European site activated at University of Bonn (Nov 24, 2025)
• EMA Clinical Trial Application approved, enabling EU registrational trial activity
• $20 million grant from Cancer Prevention and Research Institute of Texas
• Nine additional EU sites to activate within 2–3 months across four countries

Negative

• None.

Insights

Clinical Development Expert

Phase 3 registrational European activation signals tangible clinical progress for eRapa in FAP.

Biodexa activated the first European site at the University of Bonn and received European CTA clearance from the European Medicines Agency, advancing the randomized, double-blind, placebo-controlled Phase 3 Serenta trial (NCT06950385) toward a registrational dataset. The trial aims to test whether eRapa can prevent disease progression in familial adenomatous polyposis, a condition that, if untreated, leads to colorectal cancer in nearly all patients by age 50.

Key dependencies include enrollment pace across Europe and the US, timely activation of nine additional European sites over the next 2-3 months, and data quality from a double-blind, placebo-controlled design. The announcement cites collaborative support from Emtora Biosciences, CRO Precision for Medicine, and a $20 million grant from the Cancer Prevention and Research Institute of Texas, which should materially support trial operations but does not itself guarantee successful enrollment or outcomes.

Watch for cumulative enrollment updates and site activation progress over the next 3–6 months and for interim operational readouts that may affect timeline assumptions. Regulatory acceptance of the registrational design by the EMA is a positive sign for future marketing submissions if primary endpoints are met.

Regulatory & Commercial Expert

EMA CTA approval and first EU site activation reduce regulatory and geographic execution risk ahead of registrational readout.

The combination of an approved Clinical Trial Application in Europe and initiation of screening at a major academic center strengthens the trial's geographic footprint and credibility for a registrational pathway. Expansion to nine more European sites across the Netherlands, Spain, Denmark, and Italy over the next 2-3 months and prior US enrollment beginning in August 2025 creates a multi-region dataset appropriate for regulatory review.

Risks remain operational: the speed of site activations, cross-country regulatory logistics, and consistent protocol implementation across sites will determine timeline and data integrity. Monitor site activation milestones, regional enrollment rates, and any protocol amendments over the coming 6–12 months as the most concrete signals of whether the registrational program stays on track.

November 24, 2025

Biodexa Activates First European Site for Registrational Phase 3 Serenta Trial in FAP

Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) announced today that the University of Bonn, Germany is now actively screening patients for the Phase 3 Serenta clinical trial evaluating eRapa in familial adenomatous polyposis (FAP). This marks the first European site activation for the registrational Serenta trial, representing a major milestone in expanding FAP treatment options to European patients who currently have no approved non-surgical therapeutic alternatives.

Commenting, Gary Shangold MD, Chief Medical Officer of Biodexa said “Coming shortly after approval of our Clinical Trial Application by the European Medicines Agency, opening of the first site in Europe for our Serenta trial in FAP is another major milestone. The support of our collaborators, Emtora Biosciences, our European CRO Precision for Medicine and the $20 million grant from the Cancer Prevention and Research Institute of Texas have helped make this possible.”

The Serenta Trial
The randomized, double-blind, placebo-controlled Serenta trial (NCT06950385) is designed to evaluate whether eRapa can prevent disease progression in patients with FAP. If left untreated, FAP leads to colorectal cancer in nearly all patients by age 50. Currently, the only treatment option available to FAP patients is sequential surgical resection of much of the gastrointestinal tract, with consequential impact on quality of life. Nine additional European sites will activate during the next 2-3 months across the Netherlands, Spain, Denmark, and Italy. The Serenta trial began enrolling in the US in August 2025. For more information about the Serenta trial, including eligibility criteria and site locations, 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 US¹ and one in 11,300 to 37,600 in Europe². Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.

About eRapa

eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis³. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune®(Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. eRapa is protected by a number of issued patents which extend through 2035, with other pending applications potentially providing further protection beyond 2035.

The Cancer Prevention and Research Institute of Texas
To date, CPRIT has awarded $2.9 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 237 distinguished researchers, supported the establishment, expansion or relocation of 43 companies to Texas and generated over $5.7 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.4 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment to provide an additional $3 billion to CPRIT for a total $6 billion investment in cancer research and prevention. Learn more at https://cprit.texas.gov/.

1.        www.rarediseases.org
2.        www.orpha.net
3.        Tian et al., mTOR Signaling in Cancer and mTOR Inhibitors in Solid Tumor Targeting Therapy, Int J Mol Sci. 2019 Feb; 20(3): 755

For more information, please contact:

Biodexa Pharmaceuticals PLC

Gary Shangold MD, CMO

Tel: +44 (0)29 20480 180

www.biodexapharma.com

About Biodexa Pharmaceuticals PLC

Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer; tolimidone, under development for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications.

eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis.

Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycaemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent.

MTX110 is a solubilized formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity.

Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com.

Forward-Looking Statements
Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.

Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.

FAQ

What did Biodexa (BDRX) announce on November 24, 2025 about the Serenta trial?

Biodexa announced the University of Bonn is the first activated European site for the Phase 3 Serenta trial in FAP.

What is the Serenta trial (NCT06950385) testing for Biodexa (BDRX)?

The Serenta trial is a randomized, double-blind, placebo-controlled Phase 3 study evaluating eRapa to prevent disease progression in FAP patients.

Has Biodexa (BDRX) received regulatory clearance to run the Serenta trial in Europe?

Yes; the company said its Clinical Trial Application was approved by the European Medicines Agency before the first EU site activation.

How many additional European sites will Biodexa (BDRX) activate and on what timeline?

Nine additional European sites are expected to activate over the next 2–3 months across the Netherlands, Spain, Denmark, and Italy.

What funding supported Biodexa's (BDRX) European Serenta trial activation?

The company cited support from collaborators and a $20 million grant from the Cancer Prevention and Research Institute of Texas.

When did the Serenta trial begin enrolling in the US for Biodexa (BDRX)?

The Serenta trial began enrolling in the US in August 2025.