CARDIFF, U.K., August 19, 2026
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) announced a major recruitment milestone for its Serenta registrational Phase 3 trial of eRapa in familial adenomatous polyposis (FAP), with 87 subjects recruited, representing more than half of the planned 168 participants. The randomized, double-blind, placebo-controlled study is evaluating eRapa, an oral formulation of rapamycin (sirolimus), as a potential treatment for FAP, a hereditary condition characterized by the development of numerous colorectal polyps and a high risk of colorectal cancer if left untreated. The Serenta study, registered as NCT06950385, is currently recruiting across 29 clinical sites in the United States and five European countries, while three additional Canadian sites are expected to begin shortly. The recruitment milestone keeps Biodexa’s registrational program moving toward its planned clinical readouts.
Serenta Trial Crosses 50% Recruitment Milestone
The Serenta Phase 3 trial is planned to enroll 168 participants randomized in a 2:1 ratio to eRapa or placebo. Biodexa said 87 subjects have now been recruited, taking enrollment beyond the halfway point of the study’s target. The company is conducting the trial across a geographically broad network of FAP treatment centers, with additional Canadian sites expected to expand recruitment capacity. The protocol includes a composite progression-free survival (PFS) endpoint, which defines the types of events counted toward the study’s efficacy assessment. Biodexa plans to conduct a futility analysis after 25 PFS events, providing an opportunity to assess whether the study is demonstrating sufficient activity to justify continuation. A planned database lock is expected after 75 PFS events. Crossing the 50% recruitment threshold is therefore an important operational milestone, although it does not yet establish whether eRapa will demonstrate a positive treatment effect in the registrational trial. Final clinical significance will depend on the PFS outcomes and statistical analysis generated from the study.
eRapa Targets mTOR Biology in FAP Polyps
Familial adenomatous polyposis is a serious inherited gastrointestinal disorder in which large numbers of adenomatous polyps develop in the colon and rectum, often beginning during adolescence. Without effective management, the condition can progress to colorectal cancer, making lifelong surveillance and surgical intervention central components of current care. Biodexa is developing eRapa, a proprietary oral capsule formulation of rapamycin, to target the biological mechanisms associated with FAP polyps. Rapamycin is an mTOR inhibitor, and mTOR signaling has important roles in cellular metabolism, growth and proliferation and can become activated during tumor development. Biodexa has highlighted evidence showing mTOR overexpression in FAP polyps, providing the biological rationale for evaluating eRapa in this population. The company’s Phase 3 program follows an earlier open-label Phase 2 study, with data presented at major gastrointestinal research meetings in 2024. eRapa has also received Orphan Drug Designation in both the United States and Europe, supporting its development for this rare hereditary disease.
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Phase 3 Program Supported by $20 Million CPRIT Grant
The advancement of Serenta also represents an important step in Biodexa’s broader cancer prevention development strategy, with the Phase 3 program supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT). The company is developing eRapa not only for FAP but also for non-muscle-invasive bladder cancer, while other pipeline programs include MTX240 for gastrointestinal stromal tumors (GIST) and tolimidone for type 1 diabetes. MTX240 is being developed as a molecular glue designed to bring PDE3A and SLFN12 together in GIST cells, potentially triggering RNase-mediated apoptosis through a mechanism independent of KIT or PDGFR signaling. For Serenta, however, the immediate focus remains completion of recruitment and execution of the registrational Phase 3 FAP study. With more than half of the planned participants now enrolled, Biodexa has reached a meaningful development milestone, but the key value inflection remains ahead: whether eRapa can demonstrate a clinically meaningful PFS benefit and potentially establish a new pharmacological treatment approach for FAP patients who currently rely heavily on surveillance and surgical management.
Source: Biodexa Pharmaceuticals press relese
