How Biodexa Is Racing To Get Its Phase 3 Program in FAP Under Way And Gain First-Mover Advantage in a $7Bn Addressable Market
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.
Biodexa Pharmaceuticals (NASDAQ:BDRX) sta portando avanti il suo programma di Fase 3 per eRapa, una formulazione orale in compresse di rapamicina, per il trattamento della Poliposi Adenomatosa Familiare (FAP). L'azienda ha raggiunto importanti traguardi regolatori, tra cui lo status di Fast Track della FDA e la designazione di Farmaco Orfano sia negli Stati Uniti che in Europa.
eRapa ha mostrato risultati promettenti in Fase 2 con un tasso di non progressione dell'89% e una riduzione mediana del 29% del carico poliposo a 12 mesi. L'azienda ha avviato il trial 'Serenta' (NCT06950385) negli USA e ha presentato una domanda per la sperimentazione clinica in Europa, mirando a un mercato indirizzabile da 7 miliardi di dollari.
Con 30 siti clinici individuati tra Stati Uniti ed Europa, finanziamenti assicurati inclusa una concessione da 20 milioni di dollari e un potenziale vantaggio da pioniere, Biodexa si posiziona davanti ai concorrenti Recursion Pharmaceuticals (RXRX) e Tempest Therapeutics (TPST) nella corsa per sviluppare la prima opzione terapeutica approvata per la FAP.
Biodexa Pharmaceuticals (NASDAQ:BDRX) está avanzando en su programa de Fase 3 para eRapa, una formulación oral en tabletas de rapamicina, para tratar la Poliposis Adenomatosa Familiar (FAP). La compañía ha logrado hitos regulatorios importantes, incluyendo el estatus Fast Track de la FDA y la designación de Medicamento Huérfano tanto en EE. UU. como en Europa.
eRapa demostró resultados impresionantes en Fase 2 con una tasa de no progresión del 89% y una reducción mediana del 29% en la carga de pólipos a los 12 meses. La compañía ha iniciado su ensayo 'Serenta' (NCT06950385) en EE. UU. y presentó una Solicitud de Ensayo Clínico en Europa, apuntando a un mercado direccionable de 7 mil millones de dólares.
Con 30 sitios clínicos identificados en EE. UU. y Europa, financiamiento asegurado incluyendo una subvención de 20 millones de dólares, y una posible ventaja de ser pionero, Biodexa se posiciona por delante de sus competidores Recursion Pharmaceuticals (RXRX) y Tempest Therapeutics (TPST) en la carrera para desarrollar la primera opción terapéutica aprobada para la FAP.
Biodexa Pharmaceuticals (NASDAQ:BDRX)는 가족성 선종성 폴립증(FAP) 치료를 위한 경구용 라파마이신 제제인 eRapa의 3상 프로그램을 진행 중입니다. 회사는 FDA 패스트트랙 지정과 미국 및 유럽에서의 희귀의약품 지정 등 중요한 규제 마일스톤을 달성했습니다.
eRapa는 2상에서 비진행률 89%와 12개월 시점에서 폴립 부담 중간값 29% 감소라는 인상적인 결과를 보였습니다. 회사는 미국에서 'Serenta' 임상시험(NCT06950385)을 시작했으며, 유럽에서는 임상시험 신청서를 제출하여 70억 달러 규모의 시장을 목표로 하고 있습니다.
미국과 유럽 전역에 30개의 임상 시험 사이트를 확보하고, 2천만 달러의 보조금을 포함한 자금을 확보했으며, 선두주자 이점까지 갖춘 Biodexa는 경쟁사인 Recursion Pharmaceuticals (RXRX)와 Tempest Therapeutics (TPST)를 앞서며 FAP에 대한 최초 승인 치료 옵션 개발 경쟁에서 우위를 점하고 있습니다.
Biodexa Pharmaceuticals (NASDAQ:BDRX) fait progresser son programme de Phase 3 pour eRapa, une formulation orale en comprimés de rapamycine, destinée au traitement de la Polypose Adénomateuse Familiale (FAP). La société a atteint des étapes réglementaires importantes, notamment le statut Fast Track de la FDA et la désignation de médicament orphelin aux États-Unis et en Europe.
eRapa a démontré des résultats impressionnants en Phase 2 avec un taux de non-progression de 89% et une réduction médiane de 29% de la charge polypeuse à 12 mois. La société a lancé son essai 'Serenta' (NCT06950385) aux États-Unis et déposé une demande d'essai clinique en Europe, visant un marché adressable de 7 milliards de dollars.
Avec 30 sites cliniques identifiés aux États-Unis et en Europe, un financement sécurisé incluant une subvention de 20 millions de dollars, et un avantage potentiel de premier entrant, Biodexa se positionne devant ses concurrents Recursion Pharmaceuticals (RXRX) et Tempest Therapeutics (TPST) dans la course au développement de la première option thérapeutique approuvée pour la FAP.
Biodexa Pharmaceuticals (NASDAQ:BDRX) treibt sein Phase-3-Programm für eRapa voran, eine orale Tablettenformulierung von Rapamycin zur Behandlung der Familiären Adenomatösen Polyposis (FAP). Das Unternehmen hat bedeutende regulatorische Meilensteine erreicht, darunter den FDA Fast Track-Status und die Orphan-Drug-Zulassung sowohl in den USA als auch in Europa.
eRapa zeigte beeindruckende Phase-2-Ergebnisse mit einer 89%igen Nicht-Progressionsrate und einer medianen Reduktion der Polypenlast um 29% nach 12 Monaten. Das Unternehmen hat die 'Serenta'-Studie (NCT06950385) in den USA gestartet und einen Antrag für eine klinische Studie in Europa eingereicht, mit einem adressierbaren Markt von 7 Milliarden US-Dollar.
Mit 30 identifizierten klinischen Studienzentren in den USA und Europa, gesicherter Finanzierung einschließlich eines 20-Millionen-Dollar-Zuschusses und einem potenziellen First-Mover-Vorteil positioniert sich Biodexa vor den Wettbewerbern Recursion Pharmaceuticals (RXRX) und Tempest Therapeutics (TPST) im Rennen um die Entwicklung der ersten zugelassenen Therapieoption für FAP.
- 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
- 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
Insights
Biodexa's Phase 3 FAP program advances with regulatory advantages and $20M funding, targeting untapped $7B market opportunity.
Biodexa Pharmaceuticals (BDRX) has positioned itself as a potential first-mover in the untreated Familial Adenomatous Polyposis (FAP) market with its oral rapamycin formulation, eRapa. The company has methodically built a competitive advantage through several critical regulatory milestones that materially de-risk their clinical pathway.
The dual regulatory advantages are particularly significant - FDA Fast Track designation following impressive Phase 2 data (89% non-progression rate and 29% median polyp reduction), alongside Orphan Drug status in both US and Europe. These designations provide accelerated review pathways and potential marketing exclusivity, creating substantial barriers to competition.
Financially, the additional
The competitive landscape shows Biodexa ahead of rivals Recursion Pharmaceuticals (Phase 1b/2) and Tempest Therapeutics (preparing for Phase 2) - giving Biodexa potential timing advantage in the
The clinical strategy targeting the mTOR pathway is mechanistically sound, as overexpression of mTOR in FAP polyps provides a clear biological rationale. If successful, eRapa would represent the first non-surgical treatment option for a condition that currently requires colon/rectum resection as standard of care.
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
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