On October 13, 2026 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) ("Biodexa" or "the Company"), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers reported that it has enrolled 100 patients in its registrational Phase 3 trial of eRapa in Familial Adenomatous Polyposis (FAP), NCT06950385. The trial, branded "Serenta" is recruiting at 29 clinical sites across the US and five countries in Europe with a further two sites in Canada expected to be initiated shortly.
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The Serenta protocol provides for a pre-specified futility analysis after 25 Progression Free Survival (PFS) events and database lock after 75 PFS events in the Serenta trial. The Serenta protocol includes a composite endpoint which defines the nature of the PFS events.
Commenting, Stephen Stamp, Chief Executive Officer of Biodexa said "Enrolment of the 100th patient represents an important milestone for Serenta and reflects the continued strong recruitment performance across our participating sites. Based on the current rate of PFS event accrual, the pre-specified futility analysis could take place early next year with database lock potentially occurring around the end of next year, both significantly sooner than originally anticipated".
About Familial Adenomatous Polyposis
FAP is characterized by the proliferation of polyps in the colon, duodenum and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to colorectal cancer. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Drug Designation in the US and in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and generally safe mTOR inhibitor like eRapa to treat FAP.
About eRapa
eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis. Data from an open label Phase 2 trial were presented at Digestive Disease Week and InSIGHT 2024 in May and June 2024, respectively. Based on those data, Biodexa initiated a double-blind, placebo-controlled Phase 3 registrational trial in the US and Europe and plans to enrol 168 subjects randomized 2:1, drug: placebo. The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas.
(Press release, Biodexa Pharmaceuticals, OCT 13, 2026, View Source [SID1234673375])