November 24, 2025 — Leads & Copy —
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has activated its first European site at the University of Bonn, Germany, for patient screening in the Phase 3 Serenta clinical trial. The trial will evaluate eRapa in familial adenomatous polyposis (FAP).
This marks a significant step in providing European patients with FAP a non-surgical therapeutic option, as there are currently no approved alternatives.
According to Biodexa Chief Medical Officer Gary Shangold MD, the European Medicines Agency’s approval of their Clinical Trial Application and the Serenta trial’s first European site activation are major milestones. Shangold also acknowledged the support of Emtora Biosciences, Precision for Medicine (the European CRO), and a $20 million grant from the Cancer Prevention and Research Institute of Texas.
The Serenta trial (NCT06950385) is a randomized, double-blind, placebo-controlled study evaluating eRapa’s effectiveness in preventing disease progression in FAP patients. Untreated FAP leads to colorectal cancer in nearly all patients by age 50, and the current standard of care involves sequential surgical resection of the gastrointestinal tract.
In the next few months, nine additional European sites in the Netherlands, Spain, Denmark, and Italy will be activated. Enrollment in the US began in August 2025.
Familial adenomatous polyposis (FAP) is a rare, inherited condition causing the development of numerous colorectal polyps, leading to a near-certain risk of colorectal cancer if untreated. There is currently no approved therapeutic option for treating FAP patients, active surveillance and surgical resection remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum.
The hereditary component of FAP has a reported prevalence of one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. mTOR over-expression has been shown in FAP polyps, suggesting the efficacy of using an mTOR inhibitor like eRapa to treat FAP.
Emtora Biosciences’ eRapa is a proprietary oral capsule formulation of rapamycin, an mTOR inhibitor involved in regulating cellular metabolism, growth, and proliferation, and activated during tumorigenesis.
Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune®(Pfizer). Using nanotechnology and pH-sensitive polymers, eRapa aims to address the poor bioavailability, variable pharmacokinetics, and toxicity of other rapamycin forms. Patents for eRapa extend through 2035, with pending applications potentially offering further protection.
The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded $2.9 billion in grants to research institutions and organizations in Texas. CPRIT funding has supported the recruitment of 237 researchers, the establishment of 43 companies in Texas, and has generated over $5.7 billion in additional public and private investment. CPRIT funding has advanced scientific knowledge and provided 7.4 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties.
Gary Shangold MD, CMO, Biodexa Pharmaceuticals PLC, Tel: +44 (0)29 20480 180
Source: Biodexa Pharmaceuticals PLC
