Biodexa Pharmaceuticals Begins European Enrollment In Phase 3 Serenta Trial As University Of Bonn Registers First Three Patients For eRapa In Familial Adenomatous Polyposis

Biodexa Pharmaceuticals PLC, a clinical-stage biopharmaceutical company developing innovative treatments for diseases with significant unmet medical needs, announced that the University of Bonn in Germany has enrolled the first three patients into the European arm of its pivotal Phase 3 Serenta trial. The study is evaluating eRapa, an investigational therapy for familial adenomatous polyposis (FAP), a mostly inherited condition that almost inevitably leads to colorectal cancer if not treated.

Dr. Robert Hüneburg, gastroenterologist and lead investigator at the University Hospital Bonn, said that his team is pleased to be the first European center to activate and enroll patients in the trial. He noted that eRapa could become an important treatment option for individuals with FAP, who currently have very limited choices beyond invasive surgical removal of parts—or sometimes the entirety—of the gastrointestinal tract, a procedure that can significantly impact quality of life.

The Serenta trial (NCT06950385) is a double-blind, placebo-controlled study designed to assess the safety and efficacy of eRapa in 168 patients with FAP. Participants are being randomized in a 2:1 ratio to receive either eRapa or placebo. All study locations have been identified and are undergoing onboarding processes. Over the next two to three months, nine additional European sites across the Netherlands, Spain, Denmark, and Italy are expected to begin enrolling patients. The U.S. arm of the trial began enrolling in August 2025. The program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

FAP is a rare hereditary disorder characterized by the formation of hundreds to thousands of polyps in the colon or rectum, typically beginning in adolescence. Without treatment, nearly all patients develop colorectal cancer. There are currently no approved medical therapies for FAP, and management relies largely on active monitoring and surgical removal of affected portions of the gastrointestinal tract. The disorder affects an estimated one in 5,000 to 10,000 individuals in the United States and one in 11,300 to 37,600 people in Europe.

eRapa is a proprietary oral capsule formulation of rapamycin (sirolimus), an mTOR inhibitor. The mTOR pathway is a key regulator of cell metabolism, growth, and proliferation and is known to be activated during tumor development. Research shows that mTOR is over-expressed in FAP-associated polyps, supporting the rationale for using a potent, well-characterized mTOR inhibitor such as eRapa in this patient population. Rapamycin is already approved in the United States for preventing organ rejection in kidney transplant patients under the brand name Rapamune (Pfizer). eRapa uses nanotechnology and pH-sensitive polymers to improve issues typically associated with rapamycin, including poor bioavailability, variable pharmacokinetics, and toxicity. The formulation is covered by issued patents extending through 2035, with additional applications pending that may offer further protection.

CPRIT has played a major role in advancing cancer research and innovation in Texas. To date, the organization has awarded $2.9 billion in grants to support academic research, product development, and cancer prevention initiatives. CPRIT funding has contributed to the recruitment of 237 leading scientists, supported 43 companies relocating or expanding in Texas, and helped generate more than $5.7 billion in public and private investment. Its programs have also enabled 7.4 million cancer prevention and early detection services across all 254 Texas counties. In 2019, Texas voters approved an additional $3 billion in funding for CPRIT, bringing the total investment in cancer research and prevention initiatives to $6 billion.