BDRX - Biodexa Sets the Stage for eRapa's Phase 3 Leap in FAP Treatment

2025-03-19 08:16:27 ET

DENVER, Colo., Mar 19, 2025 ( 247marketnews.com )- Biodexa Pharmaceuticals (NASDAQ: BDRX ) is charging toward the launch of a Phase 3 trial for eRapa, its proprietary rapamycin tablet aimed at treating familial adenomatous polyposis (FAP). With FDA Fast Track designation secured, a successful protocol meeting in the books, and clinical research organizations (CROs) locked in, Biodexa is on track to kick off this fully funded study next quarter.

FAP, an inherited condition, floods the gastrointestinal tract with hundreds or thousands of precancerous polyps, often striking in the mid-teens and pushing patients toward near-certain colon cancer without surgical intervention. eRapa, Biodexa’s oral mTOR inhibitor designed to slow the protein’s overactivity, a known driver of FAP polyp growth.

Stephen Stamp, Biodexa’s CEO and CFO, commented, “Too much mTOR has been linked to cancer and has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using an mTOR inhibitor like eRapa to treat FAP.”

Recent weeks have turbocharged Biodexa’s momentum. The FDA granted Fast Track status, signaling eRapa’s potential to fill a critical gap. A Type C meeting with FDA’s gastroenterology and oncology teams finalized the Phase 3 protocol, nailing down a composite endpoint, statistical plan, and safety database.

Adding to the lineup, Biodexa tapped Precision for Medicine as its European CRO, complementing LumaBridge’s U.S. role.

The Phase 3 trial—a double-blind, placebo-controlled study—will enroll around 168 high-risk FAP patients across 30 sites in the U.S. and Europe. It builds on a Phase 2 success that delivered a 17% median polyp burden reduction and a 75% non-progression rate overall, with the chosen Cohort 2 dosage hitting 89% non-progression and 29% reduction at 12 months. Fully funded by a $17 million CPRIT grant and Biodexa’s $8.5 million match (totaling $25.5 million), this trial could redefine FAP care.

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