FDA Greenlights Biodexa’s eRapa Phase 3 Path for FAP Treatment

March 10, 2025

DENVER, Colo., Mar 10, 2025 (247marketnews.com)- Biodexa Pharmaceuticals (NASDAQ:BDRX) announced a successful Type C meeting with the U.S. Food and Drug Administration (FDA), paving the way for its registrational Phase 3 study of eRapa in familial adenomatous polyposis (FAP). With a finalized protocol in sight and site recruitment set to kick off next quarter, Biodexa is poised to take a step toward delivering the first disease-modifying therapy for this precancerous condition—a milestone backed by $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT) and a $8.5 million company match.

Dr Gary Shangold, Chief Medical Officer of Biodexa, stated, “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.”

The Type C meeting built on a fruitful End of Phase 2 discussion with the FDA, fueled by promising data unveiled at Digestive Disease Week in May 2024 (six-month results) and InSight in Barcelona in June 2024 (12-month results). Those Phase 2 findings showcased eRapa—a rapamycin formulation targeting the mTOR pathway—slowing polyp growth in FAP patients, a group facing near-certain colorectal cancer without intervention. The Type C talks zeroed in on critical pieces: the statistical plan, safety database, and a composite endpoint blending polyp burden and progression. With input from the FDA’s Gastroenterology and Oncology Divisions, Biodexa emerged with a clear runway to launch its pivotal trial in Q2 2025.

The Phase 3 setup is a double-blind, placebo-controlled study enrolling 168 FAP patients, randomized 2:1 (drug to placebo), across roughly 30 sites in the U.S. and Europe. eRapa affects 1 in 10,000 people—often requiring colectomy by age 40.

If successful, it would be the first drug to alter FAP’s relentless course, tapping into a $1 billion-plus market for rare GI oncology therapies.

About 24/7 Market News
As a pioneer in digital financial market media, 24/7 Market News (24/7MN) is dedicated to the swift distribution of financial market news and information. 24/7 MN incorporates comprehensive corporate communications resources and tools to engage the investment community. Visit 24/7 Market News website here.

24/7 MARKET NEWS, INC Disclaimer
Please go to https://247marketnews.com/disclaimer/ for disclaimer information.

CONTACT:
24/7 Market News
Editor@247marketnews.com

Related news for (BDRX)

NASDAQ and NYSE quotes and data are delayed 15 minutes unless indicated otherwise. Market data and exchange information are provided for informational purposes only and is not intended for trading purposes. Neither 24/7 Market News Editors, 247 Market News, or data and content providers shall be liable for any errors or omissions, delays, misquotes or other market information relayed in any press materials. You should Use Realtime data to conduct due diligence before investing or trading, and trading in any stock is risky you could lose all your money.