Biodexa Moves Into Phase 3 With eRapa For FAP With First Patients Enrolled
Biodexa Pharmaceuticals (NASDAQ:BDRX) has initiated its Phase 3 trial for eRapa, a proprietary encapsulated rapamycin treatment for familial adenomatous polyposis (FAP). The company received an additional $3 million grant from the Cancer Prevention & Research Institute of Texas, bringing total non-dilutive funding to $20 million for the Phase 3 trial.
The Phase 2 trial showed promising results with a 29% median decrease in polyp burden and 89% non-progression rate at 12 months in cohort 2. The Phase 3 study will involve 168 patients across approximately 30 clinical sites in the U.S. and Europe. With Fast Track status and Orphan Drug designation, Biodexa is positioned to be first-to-market in an estimated $7.3 billion addressable market with no current therapeutic options.
Biodexa Pharmaceuticals (NASDAQ:BDRX) ha avviato lo studio di Fase 3 per eRapa, la sua formulazione proprietaria di rapamicina incapsulata destinata al trattamento della poliposi adenomatosa familiare (FAP). L'azienda ha ottenuto un ulteriore contributo di 3 milioni di dollari dal Cancer Prevention & Research Institute of Texas, portando il finanziamento non diluitivo complessivo a 20 milioni di dollari per la Fase 3.
La Fase 2 ha mostrato risultati incoraggianti con una riduzione mediana del 29% della quantità di polipi e un tasso di non progressione dell'89% a 12 mesi nel coorte 2. Lo studio di Fase 3 arruolerà 168 pazienti in circa 30 centri clinici tra Stati Uniti ed Europa. Con lo status Fast Track e la designazione Orphan Drug, Biodexa punta a essere la prima sul mercato in un mercato potenziale stimato di 7,3 miliardi di dollari dove oggi non esistono opzioni terapeutiche approvate.
Biodexa Pharmaceuticals (NASDAQ:BDRX) ha iniciado su ensayo de fase 3 para eRapa, su formulación propietaria de rapamicina encapsulada para la poliposis adenomatosa familiar (FAP). La compañía recibió una subvención adicional de 3 millones de dólares del Cancer Prevention & Research Institute of Texas, elevando la financiación no dilutiva total a 20 millones de dólares para el ensayo de fase 3.
El ensayo de fase 2 mostró resultados prometedores con una reducción mediana del 29% en la carga de pólipos y una tasa de no progresión del 89% a 12 meses en la cohorte 2. El estudio de fase 3 incluirá a 168 pacientes en aproximadamente 30 centros clínicos en EE. UU. y Europa. Con la designación Fast Track y Orphan Drug, Biodexa está posicionada para llegar primera al mercado en un mercado direccionable estimado en 7.300 millones de dólares sin opciones terapéuticas actuales.
Biodexa Pharmaceuticals (NASDAQ:BDRX)가 유전성 가족성 선종성 용종증(FAP) 치료를 위한 독점 캡슐화 라파마이신 제제 eRapa의 3상 임상을 시작했습니다. 회사는 텍사스 암 예방·연구소(Cancer Prevention & Research Institute of Texas)로부터 추가로 300만 달러 보조금을 받아 3상 임상에 대한 희석 없는 총 자금이 2,000만 달러가 되었습니다.
2상에서는 용종 부담이 중앙값 기준 29% 감소하고 12개월 시점 코호트2에서 비진행률이 89%로 유망한 결과를 보였습니다. 3상 연구에는 미국과 유럽의 약 30개 임상 사이트에서 168명 환자가 참여할 예정입니다. Fast Track 지정과 희귀의약품(Orphan Drug) 지정으로 Biodexa는 현재 치료 옵션이 없는 약 73억 달러 규모의 목표 시장에서 선두 진입할 준비가 되어 있습니다.
Biodexa Pharmaceuticals (NASDAQ:BDRX) a lancé son essai de phase 3 pour eRapa, sa formulation brevetée de rapamycine encapsulée destinée à la polypose adénomateuse familiale (FAP). La société a reçu une subvention supplémentaire de 3 millions de dollars du Cancer Prevention & Research Institute of Texas, portant le financement non dilutif total à 20 millions de dollars pour l'essai de phase 3.
L'essai de phase 2 a donné des résultats prometteurs avec une réduction médiane de 29 % de la charge en polypes et un taux de non‑progression de 89 % à 12 mois dans la cohorte 2. L'étude de phase 3 impliquera 168 patients dans environ 30 centres cliniques aux États‑Unis et en Europe. Bénéficiant du statut Fast Track et de la désignation Orphan Drug, Biodexa est bien placée pour être la première sur un marché adressable estimé à 7,3 milliards de dollars où il n'existe actuellement aucune option thérapeutique.
Biodexa Pharmaceuticals (NASDAQ:BDRX) hat die Phase‑3‑Studie für eRapa gestartet, eine firmeneigene einkapselte Rapamycin‑Behandlung für familiäre adenomatöse Polyposis (FAP). Das Unternehmen erhielt einen zusätzlichen 3‑Millionen‑Dollar‑Zuschuss vom Cancer Prevention & Research Institute of Texas, womit die nicht verwässernde Gesamtfinanzierung für die Phase‑3‑Studie 20 Millionen Dollar beträgt.
Die Phase‑2‑Studie zeigte vielversprechende Ergebnisse mit einer medianen Reduktion der Polypenlast um 29 % und einer Nicht‑Progressionsrate von 89 % nach 12 Monaten in Kohorte 2. Die Phase‑3‑Studie wird 168 Patienten an rund 30 Studienzentren in den USA und Europa einschließen. Mit Fast‑Track‑Status und Orphan‑Drug‑Zulassung ist Biodexa gut positioniert, als Erste in einen geschätzten adressierbaren Markt von 7,3 Milliarden Dollar einzutreten, in dem derzeit keine Therapeutika verfügbar sind.
- Secured total non-dilutive funding of $20 million for Phase 3 trial
- Achieved 29% median decrease in polyp burden and 89% non-progression rate in Phase 2 cohort 2
- Obtained both FDA Fast Track status and EU Orphan Drug designation
- Potential first-mover advantage in $7.3B addressable market with no current therapeutic options
- Secured market exclusivity for 7 years in US and 10 years in Europe upon launch
- Small market capitalization of only $3.5M suggests significant financing needs ahead
- Faces potential competition from Recursion Pharmaceuticals and Tempest Therapeutics in Phase 2 trials
- Complex Phase 3 trial requiring coordination across 30 clinical sites in US and Europe
Insights
Biodexa advances to Phase 3 with eRapa for FAP, potentially capturing first-mover advantage in a $7B untreated market.
Biodexa Pharmaceuticals has reached a significant milestone by enrolling the first patients in its Phase 3 registrational trial for eRapa, their encapsulated rapamycin formulation targeting familial adenomatous polyposis (FAP). This advancement positions them ahead of competitors like Recursion and Tempest, who remain in Phase 2 development for the same indication.
The trial's financial foundation appears solid with
What makes this particularly compelling is the Phase 2 data that propelled them forward - showing a
The regulatory advantages already secured - FDA Fast Track status and European Orphan Drug designation - provide potential acceleration through the approval process and subsequent market exclusivity (7 years US, 10 years Europe). This combination of late-stage development, compelling efficacy data, and regulatory advantages creates meaningful differentiation in addressing an indication with no approved therapeutic options, where patients currently face inevitable surgical removal of the colon and rectum.
The
On Track To Be First Mover In
By: Benzinga Staff Writer
CARDIFF, UK / ACCESS Newswire / September 8, 2025 / Biodexa Pharmaceuticals PLC. (NASDAQ:BDRX), a late clinical-stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, has launched its registrational Phase 3 trial of eRapa - its proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP), a debilitating disease of the lower GI tract.
This post was written and published as a collaboration between the in-house editorial team at Benzinga and Biodexa Pharmaceuticals PLC. with financial support from Biodexa. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.
Multiple Key Milestones So Far in 2025
The company just enrolled the first patients in the Phase 3 trial. Earlier this year, its collaboration partner, Rapamycin Holdings, Inc., which does business as Emtora Biosciences, was awarded an additional
All three milestones put the company in a clear leadership position in advancing a drug that could bring relief to people suffering from this largely genetic disease.
A Rare Disease But A
FAP causes hundreds or thousands of precancerous polyps to grow throughout the lower gastrointestinal tract. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. People with FAP, which usually appears in the patient's mid-teens, end up eventually having their entire colon and rectum removed. If left untreated, there is a near
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There are reported prevalence's of FAP of one in 5,000 to 10,000 population in the U.S. and one in 11,300 to 37,600 population in Europe. Based on the lowest estimates of prevalence of 1/10,000 and 1/37,600 in the US and Europe, respectively, the adult populations in each territory of approximately 258 million and 358 million and the median annual cost of approved non-biologic orphan drugs in the US of
eRapa Could Have First Mover Advantage
Treating FAP has proven difficult over the years. While Pfizer Inc.'s (PFE) Celecoxib (Celebrex), a Cox-2 inhibitor, was approved to reduce the number of polyps for FAP about eight years ago, it failed a post approval study and the label was pulled. Recursion Pharmaceuticals, Inc. (RXRX) is developing REC-4881 and Tempest Therapeutics Inc (TPST) is developing TPST-1495, both for FAP and both are in Phase 2. Biodexa, with compelling Phase 2 data in hand, is already in Phase 3 and could have first mover advantage in a significant market. Orphan drug designation provides market exclusivity for eRapa of 7 years and 10 years from launch in the U.S. and Europe, respectively.
Phase 3 Trial Fueled By Additional Grant On Back Of Compelling Phase 2 Data
Biodexa's Phase 3 trial is a double-blind, placebo-controlled trial in 168 patients, randomized 2:1 drug to placebo. It is expected that the study will be conducted in approximately 30 clinical sites across the U.S. and Europe. The U.S. component of the study is being managed by LumaBridge, and the European component by Precision for Medicine LLC.
The Phase 3 trial advanced after Biodexa completed a Phase 2 trial that demonstrated a
On the back of the Phase 2 data, the Cancer Prevention & Research Institute of Texas (CPRIT) initially awarded a
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FAQ
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