Biodexa Advances eRapa Trial in Europe, Targeting $7B FAP Market

CARDIFF, UK – December 01, 2025 – Biodexa Pharmaceuticals (NASDAQ: BDRX) has achieved a significant clinical and strategic milestone, announcing the enrollment of the first European patients into its pivotal Phase 3 Serenta trial. The study evaluates eRapa, a novel therapeutic candidate for Familial Adenomatous Polyposis (FAP), a rare genetic disorder with a near-100% lifetime risk of developing colorectal cancer if left untreated. This expansion into Europe, beginning at the prestigious University of Bonn in Germany, marks a critical step forward in the company's efforts to address a major unmet medical need and unlock a potential $7 billion market.

The initiation of the European leg of the trial, which began enrolling patients in the United States in August 2025, signals robust progress for Biodexa's lead pipeline asset. For investors and market analysts, this development represents tangible execution on a late-stage clinical program, moving the company closer to a potential first-in-class, non-surgical treatment for a devastating condition.

A Transatlantic Push in Late-Stage Development

The Serenta trial (NCT06950385) is a meticulously designed, double-blind, placebo-controlled study set to enroll 168 patients across North America and Europe. Participants are randomized on a 2:1 basis to receive either eRapa or a placebo. The trial's primary objective is to assess the safety and efficacy of eRapa in halting or reversing the progression of polyps that characterize FAP.

Operational execution is being handled by seasoned clinical research organizations, with LumaBridge managing 20 sites in the United States and Precision for Medicine overseeing ten sites in Europe. Following the first enrollments in Germany, Biodexa plans an aggressive rollout across the continent, with nine additional sites slated for activation in the Netherlands, Spain, Denmark, and Italy over the next two to three months. This broad geographic footprint is crucial for ensuring timely patient recruitment for this rare disease, a common hurdle in orphan drug development.

The trial itself is event-driven, with an anticipated duration of up to 24 months after the final patient is enrolled. This design provides a flexible yet rigorous framework to gather data until the primary endpoint is met, reflecting a commitment to generating a conclusive and compelling data package for regulatory submission to authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Addressing a Desperate Unmet Need

The clinical significance of the Serenta trial cannot be overstated. FAP is a relentless inherited disease where patients develop hundreds to thousands of polyps in their colon and rectum, typically beginning in their mid-teens. Without intervention, progression to colorectal cancer is almost inevitable. The current standard of care is stark and invasive: active surveillance followed by the surgical removal of the colon and/or rectum. These procedures, while life-saving, often carry severe, life-long consequences for a patient's quality of life.

There are currently no approved pharmacological therapies for FAP, leaving a gaping void in the treatment landscape. Biodexa's eRapa aims to fill this void by offering a non-surgical intervention that could delay or even prevent the need for life-altering surgery.

Dr. Robert Hüneburg, a gastroenterologist and the lead investigator at the University Hospital, Bonn, highlighted the drug's potential. “We are pleased to be the first European center to be activated and to have enrolled the first three patients into the European arm of the Serenta trial,” he stated. “eRapa has the potential to become an important treatment option for patients with FAP, for whom currently little exists beyond surgical resection of parts or even the entire gastrointestinal tract — often with devastating consequences for quality of life.”

The Science and Commercial Opportunity

eRapa is a proprietary oral formulation of rapamycin (also known as sirolimus), a well-understood mTOR inhibitor. The scientific rationale for its use in FAP is strong; the mTOR cellular pathway, which regulates cell growth and proliferation, is known to be over-activated in FAP polyps, driving their growth. By inhibiting this pathway, eRapa targets the underlying biology of the disease.

What differentiates eRapa from standard rapamycin is Biodexa's proprietary drug delivery technology. Using nanotechnology and pH-sensitive polymers, the oral capsule is designed to improve the drug's poor bioavailability and variable absorption, potentially leading to a more consistent therapeutic effect and a better safety profile. This technological enhancement is protected by a portfolio of issued patents extending through 2035, with further applications pending.

Confidence in this approach is supported by promising Phase 2 data, where eRapa demonstrated a statistically significant 24% reduction in total polyp burden after six months of treatment. These results, combined with Orphan Drug Designation in both the US and Europe and a Fast Track designation from the FDA, have paved a structured and potentially expedited path to market. With an estimated 100,000 individuals affected by FAP across the US and Europe, the addressable market is valued at approximately $7 billion, representing a substantial commercial opportunity for the first approved non-surgical therapy.

Financial Strategy and Investor Outlook

For a micro-cap biotech firm like Biodexa, which currently has a market capitalization under $3 million, advancing a pivotal Phase 3 trial is a capital-intensive undertaking. The company’s stock (BDRX) has faced significant pressure, and financial analyses note its high cash burn rate. However, the Serenta trial's financial footing is uniquely secured by a substantial $20 million non-dilutive grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

This CPRIT grant is a game-changer, significantly de-risking the trial from a funding perspective and providing a strong external validation of the project's scientific merit. Biodexa successfully raised the required matching funds for the grant, largely through a $7 million financing via the exercise of existing warrants, shoring up its balance sheet to support the trial's execution. While the company is not yet profitable, its strong current ratio indicates it holds sufficient liquid assets to cover short-term liabilities, a crucial factor for stability during this critical growth phase.

From an investment perspective, Biodexa presents a high-risk, high-reward profile typical of late-stage clinical biotech. The stock's recent performance has placed it in what some technical indicators, like the Relative Strength Index (RSI), suggest is oversold territory. For investors with an appetite for this sector, the successful expansion of the Serenta trial into Europe is a key de-risking event and a demonstration of management's ability to execute on its strategic plan. Each milestone achieved, from site activation to patient enrollment, brings Biodexa closer to a major value inflection point and the potential transformation from a clinical-stage entity to a commercial enterprise.