LONDON, United Kingdom, June 29, 2026
Biodexa Pharmaceuticals PLC announced that Health Canada has approved the expansion of its registrational Phase 3 Serenta clinical trial evaluating eRapa for the treatment of Familial Adenomatous Polyposis (FAP) into Canada. The regulatory authorization enables the company to add three to four Canadian clinical sites to its ongoing multinational study, complementing the 29 active recruiting centers already operating across the United States and five European countries. The Serenta study is designed to enroll 168 patients, with 73 participants already recruited. Biodexa said the Canadian expansion is expected to accelerate enrollment while supporting the development of what could become the first approved medical therapy for FAP, a rare inherited disorder that significantly increases the risk of colorectal cancer and currently has no approved drug treatment.
Canadian Expansion Expected to Accelerate Patient Enrollment
The addition of Canadian clinical centers marks another important milestone for the global Serenta Phase 3 program, which has experienced increasing recruitment momentum as more European sites became operational. According to Stephen Stamp, Chief Executive Officer of Biodexa Pharmaceuticals, physician interest and positive patient engagement have contributed to improved enrollment over recent months. The company believes expanding into Canada will further strengthen recruitment timelines while increasing patient access to the investigational therapy. The randomized, double-blind, placebo-controlled trial is evaluating eRapa as a potential disease-modifying treatment for patients with Familial Adenomatous Polyposis, a rare hereditary disorder that frequently requires preventative surgical removal of the colon because of the high risk of cancer development.
eRapa Targets mTOR Pathway in Familial Adenomatous Polyposis
eRapa is Biodexa’s proprietary oral formulation of rapamycin (sirolimus), an inhibitor of the mammalian Target of Rapamycin (mTOR) signaling pathway, which plays a critical role in regulating cellular growth, metabolism, and proliferation. Research has shown that mTOR is overexpressed in FAP-associated polyps, providing a strong biological rationale for targeting this pathway to reduce disease progression. The current Phase 3 trial follows encouraging findings from an earlier Phase 2 clinical study, with results previously presented at Digestive Disease Week and the InSIGHT 2024 scientific meetings. The registrational study aims to determine whether eRapa can offer a non-surgical therapeutic option for patients living with this rare gastrointestinal cancer predisposition syndrome.
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Phase 3 Program Supported by Major Cancer Research Funding
Biodexa’s global Phase 3 development program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT), providing significant financial backing for the clinical evaluation of eRapa. The company has also secured Orphan Drug Designation for the therapy in the United States and plans to pursue similar regulatory status in Europe. If successful, eRapa could become the first approved pharmacological treatment for Familial Adenomatous Polyposis, offering patients an alternative to lifelong surveillance and major colorectal surgery. With enrollment continuing across North America and Europe, the expansion into Canada further strengthens Biodexa’s strategy to complete patient recruitment and advance the Serenta trial toward future regulatory submissions.
Source: Biodexa Pharmaceuticals press release
