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Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP
March 10, 2025
Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP
Clears the way to finalize Phase 3 protocol and recruit sites for U.S.
Phase 3 substantially funded by $17.0 million CPRIT grant and $8.5 million Company match
Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announced the results of its Type C meeting with the U.S. Food and Drug Administration (“FDA”) regarding the protocol for the planned registrational Phase 3 study of eRapa in familial adenomatous polyposis (“FAP”).
The Type C meeting followed a productive End of Phase 2 meeting with FDA and the publication of Phase 2 data of eRapa in FAP at six months at Digestive Disease Week in May 2024 and 12 months data at InSight, Barcelona in June 2024. The Type C meeting included a discussion of the statistical plan, the safety database and, most importantly, a composite endpoint for the Phase 3 study. FDA representatives from both Gastroenterology and Oncology Divisions provided valuable input into the proposed program and the Company believes there is a clear path forward for initiation of the registrational Phase 3 study in FAP in the U.S. next quarter.
The planned registrational Phase 3 study of eRapa in FAP will be a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo. It is expected the study will be conducted in approximately 30 clinical sites across the US and Europe. The US component of the study will be conducted by LumaBridge, based in San Antonio, Texas and the European component will be conducted by Precision for Medicine LLC. The Phase 3 study is supported by a $17.0 million grant from the Cancer Prevention Research Institute of Texas (“CPRIT”) and a Company match of $8.5 million which has already been paid, in full, into escrow.
Commenting, Dr Gary Shangold, Chief Medical Officer of Biodexa, said, “With no approved products for FAP, we were pleased to collaborate with FDA and our US CRO, LumaBridge, to define the regulatory pathway for eRapa in FAP. Agreement on the composite endpoint, in particular, clears the path to finalize the protocol, recruit the U.S. sites and begin patient enrolment”
Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis
February 10, 2025
Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis
Underscores unmet need for a therapeutic alternative with the potential to delay or prevent surgical removal of the colon and/or rectum
Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced today that the US Food and Drug Administration (“FDA”) has granted Fast Track designation for eRapa, a proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP). Fast track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
The designation was requested based on the potential for eRapa to address an unmet medical need for FAP, a condition which left untreated universally leads to colorectal cancer. Today, the only treatment option is surgical resection of the colon and/or rectum. Data from the Phase 2 study of eRapa in FAP showed eRapa to be safe and well-tolerated with a median 17% reduction in total polyp burden at 12 months compared with baseline and an overall 75% non-progression rate. Patients in cohort 2 experienced an 89% non-progression rate and 29% median reduction in polyp burden at 12 months compared with baseline. The dosing given to cohort 2 – daily every other week -- is the preferred dosage regimen for the upcoming registrational Phase 3 study.
eRapa in FAP
FAP is characterized as a proliferation of polyps in the colon 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 universally leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported prevalence of one in 5,000 to 10,000 in the US1 and one in 11,300 to 37,600 in Europe2. Biodexa has received US FDA Orphan Drug designation for eRapa in FAP and plans to seek a
BDRX: Decent news for Colon/Rectal Cancer issues --- many genetic. (Appears to have tiny stock FLOAT.)
BDRX new 52 week low
BDRX new 52 week low
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