Biodexa Announces Enrolment of First Patients into Pivotal Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP)
Biodexa Pharmaceuticals (NASDAQ:BDRX) has announced the enrollment of its first two patients in the pivotal Phase 3 Serenta trial for eRapa, targeting Familial Adenomatous Polyposis (FAP). The trial will be conducted across 30 sites (20 in US, 10 in Europe) and will evaluate 168 patients in a 2:1 drug/placebo randomized study.
The company aims to develop the first non-surgical treatment for FAP, a hereditary condition that typically leads to colorectal cancer if untreated. The program has received $20 million in grant funding from CPRIT and targets a $7.3 billion addressable market. The trial follows promising Phase 2 results and represents a potential breakthrough in FAP treatment, where currently only surgical resection is available.
Biodexa Pharmaceuticals (NASDAQ:BDRX) ha comunicato l'arruolamento dei primi due pazienti nello studio pivotale di Fase 3 Serenta su eRapa, rivolto alla poliposi adenomatosa familiare (FAP). Lo studio, svolto in 30 centri (20 negli USA, 10 in Europa), coinvolgerà 168 pazienti in uno schema randomizzato 2:1 farmaco/placebo.
L'azienda punta a sviluppare il primo trattamento non chirurgico per la FAP, una malattia ereditaria che, se non trattata, evolve spesso in carcinoma colorettale. Il programma ha ottenuto 20 milioni di dollari di finanziamento da CPRIT e indirizza un mercato potenziale di 7,3 miliardi di dollari. Lo studio segue risultati promettenti di Fase 2 e potrebbe rappresentare una svolta in un campo dove oggi l'unica opzione è la resezione chirurgica.
Biodexa Pharmaceuticals (NASDAQ:BDRX) ha anunciado el reclutamiento de sus dos primeros pacientes en el ensayo pivotal de Fase 3 Serenta con eRapa, dirigido a la poliposis adenomatosa familiar (FAP). El ensayo se realizará en 30 centros (20 en EE. UU., 10 en Europa) y evaluará a 168 pacientes en un estudio aleatorizado 2:1 fármaco/placebo.
La compañía pretende desarrollar el primer tratamiento no quirúrgico para la FAP, una enfermedad hereditaria que suele derivar en cáncer colorrectal si no se trata. El programa ha recibido 20 millones de dólares en subvenciones de CPRIT y apunta a un mercado potencial de 7.300 millones de dólares. El ensayo se apoya en resultados prometedores de la Fase 2 y podría suponer un avance importante en un área donde actualmente solo existe la resección quirúrgica.
Biodexa Pharmaceuticals (NASDAQ:BDRX)는 FAP를 표적으로 하는 eRapa의 중대한 3상 Serenta 시험에 첫 두 명의 환자를 등록했다고 발표했습니다. 이 임상은 30개 기관(미국 20곳, 유럽 10곳)에서 시행되며, 2:1 약물/플라시보 무작위 배정으로 168명을 평가합니다.
회사는 치료하지 않으면 대장암으로 발전하기 쉬운 유전성 질환인 FAP에 대해 첫 비수술 치료법을 개발하는 것을 목표로 하고 있습니다. 이 프로그램은 CPRIT로부터 2,000만 달러의 보조금을 받았으며, 73억 달러 규모의 잠재 시장을 겨냥합니다. 이번 시험은 유망한 2상 결과를 바탕으로 진행되며, 현재 유일한 치료 옵션인 외과적 절제에 대한 잠재적 돌파구가 될 수 있습니다.
Biodexa Pharmaceuticals (NASDAQ:BDRX) a annoncé l'inclusion de ses deux premiers patients dans l'essai pivot de Phase 3 Serenta évaluant eRapa pour la polypose adénomateuse familiale (FAP). L'étude se déroulera sur 30 sites (20 aux États‑Unis, 10 en Europe) et portera sur 168 patients dans un essai randomisé 2:1 médicament/placebo.
La société vise à développer le premier traitement non chirurgical de la FAP, une maladie héréditaire qui évolue souvent en cancer colorectal si elle n'est pas traitée. Le programme a obtenu 20 millions de dollars de subventions de la part de CPRIT et cible un marché adressable de 7,3 milliards de dollars. Cet essai fait suite à des résultats prometteurs de Phase 2 et pourrait constituer une avancée majeure dans un domaine où la résection chirurgicale est aujourd'hui la seule option.
Biodexa Pharmaceuticals (NASDAQ:BDRX) hat die Einschreibung der ersten zwei Patienten in die entscheidende Phase-3-Serenta-Studie mit eRapa bei familiärer adenomatöser Polyposis (FAP) bekannt gegeben. Die Studie wird an 30 Standorten (20 in den USA, 10 in Europa) durchgeführt und prüft 168 Patienten in einer 2:1-randomisierten Medikament/Placebo‑Studie.
Das Unternehmen verfolgt das Ziel, die erste nicht-chirurgische Behandlung für FAP zu entwickeln, eine erbliche Erkrankung, die unbehandelt meist in kolorektales Karzinom übergeht. Das Programm erhielt 20 Millionen US-Dollar Fördermittel von CPRIT und adressiert einen 7,3 Milliarden Dollar großen Markt. Die Studie baut auf vielversprechenden Phase‑2-Ergebnissen auf und könnte einen Durchbruch in einem Bereich darstellen, in dem derzeit nur chirurgische Resektion verfügbar ist.
- First mover advantage in a $7.3 billion addressable market
- Secured $20 million in grant funding from CPRIT
- Only drug candidate for FAP in Phase 3 development
- Promising Phase 2 data supporting Phase 3 trial
- Large-scale trial across 30 sites in US and Europe
- Complex Phase 3 trial requiring 168 patients could extend enrollment timeline
- No current FDA-approved drugs for FAP, indicating potential regulatory challenges
Insights
Biodexa's Phase 3 trial for eRapa in FAP represents potential first non-surgical treatment in $7.3B market with promising Phase 2 data.
Biodexa's announcement of enrolling the first patients in its pivotal Phase 3 Serenta trial marks a critical milestone in developing what could become the first-ever non-surgical treatment for Familial Adenomatous Polyposis (FAP). This rare genetic disorder, characterized by hundreds of precancerous polyps in the colon, currently has no pharmaceutical treatment options - patients must undergo sequential resections of their gastrointestinal tract, significantly impacting quality of life.
The trial design is robust - a double-blind, placebo-controlled study with 168 patients randomized in a 2:1 ratio (drug:placebo). The company has established a comprehensive clinical infrastructure with 20 sites in the US and 10 in Europe, managed by experienced CROs LumaBridge and Precision for Medicine, respectively.
What makes this particularly significant is that eRapa is the only drug candidate for FAP in Phase 3, giving Biodexa first-mover advantage in this $7.3 billion addressable market. The program has received substantial validation through $20 million in grant funding from CPRIT (Cancer Prevention Research Institute of Texas).
The mention of "promising Phase 2 data" by Dr. Cruz-Correa suggests positive efficacy signals in earlier clinical development, though specific efficacy endpoints aren't detailed in this release. If Phase 3 results replicate these promising findings, eRapa could represent a paradigm shift in FAP management, potentially sparing patients from invasive surgical interventions.
August 18, 2025
Biodexa Announces Enrolment of First Patients into Pivotal Phase 3 Serenta Trial
in Familial Adenomatous Polyposis (FAP)
Opportunity to be First Mover in
Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce the enrolment of the first two patients by the Pan American Center for Oncology Trials in San Juan, Puerto Rico into its pivotal Phase 3 Serenta trial of eRapa in patients with familial adenomatous polyposis (FAP), a mostly inherited disease that, if left untreated, almost always leads to colorectal cancer. The only current treatment option is sequential resection of the gastrointestinal tract.
Commenting, Stephen Stamp CEO and CFO of Biodexa said “Enrolling the first patients in our pivotal Phase 3 study in FAP is a seminal event for our company, our collaborator Emtora Biosciences and our CRO, LumaBridge. As the only drug candidate for FAP in Phase 3, our combined team is committed to advancing eRapa as the first non-surgical treatment for the thousands of patients worldwide suffering from this debilitating disease. We recognize both the responsibility and the opportunity to be the first mover in this
Dr. Marcia Cruz-Correa, Clinical Investigator, added “At Pan American Center for Oncology Trials, we are pleased to be part of the Serenta trial and delighted to be recognized as the first enroller of patients. Its Phase 2 data are promising and, if replicated in the Phase 3 Serenta trial, eRapa could become the first therapeutic treatment for FAP patients who currently have no options other than life-altering surgery”.
eRapa Phase 3 program
The Serenta trial (NCT06950385) is a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo to evaluate the safety and efficacy of eRapa in individuals diagnosed with FAP. All study sites have been identified and are in the process of onboarding. The US component of the trial, incorporating 20 sites, is being managed by LumaBridge based in San Antonio, Texas. The European component, comprising 10 sites will be conducted by Precision for Medicine. For more information about the Serenta trial, including eligibility criteria and specific site locations, please visit https://serentatrial.com/
About FAP
Familial adenomatous polyposis is a rare, inherited disorder characterized by the development of hundreds to thousands of colorectal polyps and a near
About eRapa
eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis3. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune®(Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. eRapa is protected by a number of issued patents which extend through 2035, with other pending applications potentially providing further protection beyond 2035.
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
The Cancer Prevention and Research Institute of Texas
To date, CPRIT has awarded
1. www.rarediseases.org
2. www.orpha.net
3. Tian et al., mTOR Signaling in Cancer and mTOR Inhibitors in Solid Tumor Targeting Therapy, Int J Mol Sci. 2019 Feb; 20(3): 755
4. Althobaiti et al. https://pmc.ncbi.nlm.nih.gov/articles/PMC9957503/
For more information, please contact:
Biodexa Pharmaceuticals PLC |
| Stephen Stamp, CEO, CFO |
| Tel: +44 (0)29 20480 180 |
| www.biodexapharma.com |
About Biodexa Pharmaceuticals PLC
Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer; tolimidone, under development for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications.
eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis.
Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycaemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent.
MTX110 is a solubilized formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity.
Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com.
Forward-Looking Statements
Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.
Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.
FAQ
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