How Biodexa Is Racing To Get Its Phase 3 Program in FAP Under Way And Gain First-Mover Advantage in a $7Bn Addressable Market
Rhea-AI Summary
Biodexa Pharmaceuticals (NASDAQ:BDRX) is advancing its Phase 3 program for eRapa, an oral tablet formulation of rapamycin, to treat Familial Adenomatous Polyposis (FAP). The company has achieved significant regulatory milestones, including FDA Fast Track status and Orphan Drug designation in both US and Europe.
eRapa demonstrated impressive Phase 2 results with an 89% non-progression rate and 29% median reduction in polyp burden at 12 months. The company has initiated its 'Serenta' trial (NCT06950385) in the US and filed a Clinical Trial Application in Europe, targeting a $7 billion addressable market.
With 30 clinical sites identified across the US and Europe, secured funding including a $20 million grant, and potential first-mover advantage, Biodexa is positioned ahead of competitors Recursion Pharmaceuticals (RXRX) and Tempest Therapeutics (TPST) in the race to develop the first approved therapeutic option for FAP.
Positive
- Phase 2 data showed strong efficacy with 89% non-progression rate and 29% polyp reduction
- Secured both FDA Fast Track status and Orphan Drug designation in US and Europe
- Received $20 million total grant funding for Phase 3 trial
- 30 clinical sites identified with first US site already screening participants
- Potential first-mover advantage in $7 billion addressable market
Negative
- No approved therapeutic option currently exists for FAP treatment
- Faces competition from other companies developing FAP treatments
- Success of Phase 3 trials not guaranteed despite positive Phase 2 results
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CARDIFF, UK / ACCESS Newswire / July 28, 2025 / Familial Adenomatous Polyposis (FAP) is an inherited condition that puts people at a much greater risk of developing colon cancer. If left untreated, there is a near
That could change if one company has its way.
Biodexa Pharmaceuticals PLC. (NASDAQ:BDRX), a clinical-stage biopharmaceutical company, reports making significant progress in developing eRapa, an oral tablet formulation of rapamycin, to treat FAP non-surgically. eRapa inhibits the mTOR (mammalian Target Of Rapamycin) protein. 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.
Key Milestones Met
Since the start of the year, Biodexa has hit several milestones with eRapa as it works to bring its treatment to the market in the U.S. and Europe. The company says it already has key opinion leaders engaged, vendors contracted, 30 sites in the U.S. and Europe identified for its Phase 3 study and funding in place, putting it ahead of its potential rivals including Recursion Pharmaceuticals Inc. (RXRX), which is currently in a Phase 1b/2 study of its treatment for FAP and Tempest Therapeutics Inc. (TPST), which in May received the go-ahead from the FDA for a Phase 2 trial of its FAP drug.
If Biodexa's eRapa treatment is shown to be successful in its Phase 3 study and the treatment gets approved, the company believes it would have first-mover advantage in what it estimates is a
Solid Regulatory Footing
In February, Biodexa received Fast Track status from the U.S. Food and Drug Administration (FDA) for eRapa. Fast Track status is designed to facilitate the development and expedite the review of drugs to treat serious conditions where there is an unmet medical need. The FDA awarded Biodexa Fast Track status after Phase 2 data showed patients experienced an
In conjunction with its Fast Track Status in the U.S., eRapa received Orphan Drug status in Europe, adding to the Orphan Drug designation in the U.S. that had been awarded some time ago. Both are designed to speed up the development of drugs that could provide significant benefits to patients who are suffering from rare, life-threatening diseases. The European Orphan Drug status also gives the drug company 10 years of marketing exclusivity and provides special incentives, including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees, reports Biodexa.
Those designations were quickly followed by Biodexa holding a Type C meeting with the FDA that included a discussion of the statistical plan, the safety database and most importantly, a composite endpoint for a Phase 3 study. FDA representatives from both the gastroenterology and oncology divisions provided valuable input into the proposed program, which is important for the success of the Phase 3 study. In Europe, Biodexa has already named Precision for Medicine LLC as the clinical research organization to conduct the European component of the Phase 3 study of eRapa.
Trials Getting Underway
The trials are now getting underway. In June, Biodexa initiated its first clinical site in the U.S. with its collaboration partner, Rapamycin Holdings Inc., which does business as Emtora Biosciences. Emtora Biosciences was awarded an additional
In Europe, Biodexa just filed a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) for its Serenta trial. A CTA is the formal regulatory submission required to obtain approval to begin a clinical trial in Europe and is similar to the Investigational New Drug (IND) application process in the United States. If approved, it would permit the Serenta trial to proceed in Europe, initially covering clinical sites in Denmark, Germany, the Netherlands and Spain, with Italy expected to be added in due course. Investors should expect more announcements from Biodexa as the Phase 3 trial hits more milestones in the weeks and months to come.
Biodexa is optimistic about its future prospects and aims to replicate the success of Palvella Therapeutics Inc. (PVLA), a biotechnology company also developing a rapamycin product for patients with rare dermatological diseases that sports a
Featured image from Biodexa
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SOURCE: Biodexa Pharmaceuticals
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FAQ
What were the Phase 2 results for Biodexa's (BDRX) eRapa treatment for FAP?
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What is the current status of Biodexa's (BDRX) Phase 3 'Serenta' trial?
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