Biodexa advances FAP treatment with phase 3 trial initiation

CARDIFF - Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), currently valued at $2.5 million in market capitalization, has initiated its Phase 3 clinical trial for eRapa, an oral tablet formulation of rapamycin aimed at treating Familial Adenomatous Polyposis (FAP), according to a company press release. InvestingPro analysis shows the company maintains more cash than debt on its balance sheet, though it’s rapidly burning through available funds.

The trial, branded as the "Serenta" study, has begun screening participants at its first U.S. clinical site. Simultaneously, Biodexa has filed a Clinical Trial Application with the European Medicines Agency to expand the study to sites in Denmark, Germany, the Netherlands, Spain, and eventually Italy. According to InvestingPro data, the company’s overall financial health score is rated as WEAK, with 10+ additional insights available to subscribers.

FAP is an inherited condition that carries nearly 100% risk of developing colon or rectal cancer if left untreated. Current standard care involves surgical removal of the colon and/or rectum, with no approved non-surgical therapeutic options available.

The company’s eRapa treatment works by inhibiting the mTOR protein, which is overexpressed in FAP polyps. Earlier Phase 2 data showed an 89% non-progression rate and a 29% median reduction in polyp burden at 12 months compared to baseline.

Regulatory support for the treatment includes Fast Track designation from the FDA and Orphan Drug status in both the U.S. and Europe, which provides development incentives and potential marketing exclusivity.

The Phase 3 program is supported by a $20 million grant from the Cancer Prevention & Research Institute of Texas awarded to Biodexa’s collaboration partner, Emtora Biosciences.

Biodexa estimates the addressable market for FAP treatment at $7 billion and aims to establish first-mover advantage if the drug receives approval. The company has identified 30 potential clinical sites across the U.S. and Europe for its Phase 3 study. Despite the significant market opportunity, investors should note the stock has declined over 95% in the past year, with analysts projecting continued losses for the current fiscal year.

In other recent news, Biodexa Pharmaceuticals PLC announced a change in the ratio of its American Depositary Receipts (ADRs), effective July 31, 2025, from one ADR representing 10,000 ordinary shares to one ADR representing 100,000 ordinary shares. The company has also filed a Clinical Trial Application with the European Medicines Agency for its Phase 3 Serenta trial targeting familial adenomatous polyposis, with plans to conduct the trial across several European countries. Additionally, Biodexa has enrolled the first patient in a Phase 2a clinical trial for Tolimidone, a drug being tested for type 1 diabetes, with the trial being conducted in Canada. In another development, the company announced a reduction in the nominal value of its ordinary shares from £0.00005 to £0.000001, as approved by shareholders at a recent general meeting. Shareholders also approved all resolutions at the meeting, including granting directors the authority to allot ordinary shares on a non-pre-emptive basis. These updates reflect significant strategic and operational moves by Biodexa Pharmaceuticals.

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