Biodexa Announces Filing of CTA in Europe for Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP)
Biodexa Pharmaceuticals (NASDAQ:BDRX) has filed a Clinical Trial Application (CTA) with the European Medicines Agency for its Phase 3 Serenta trial investigating eRapa in Familial Adenomatous Polyposis (FAP). The trial will initially cover clinical sites in Denmark, Germany, Netherlands, and Spain, with Italy to be added later.
The company has achieved several milestones for its eRapa program, including FDA Fast Track Designation, European Orphan Drug designation, and initiation of its first US clinical site. The program is supported by a $20 million grant from CPRIT. The Serenta trial (NCT06950385) is designed as a randomized, double-blind, placebo-controlled Phase 3 study, with European sites expected to begin enrollment in Q4 2025.
Biodexa Pharmaceuticals (NASDAQ:BDRX) ha presentato una Domanda di Sperimentazione Clinica (CTA) all'Agenzia Europea per i Medicinali per il suo studio di Fase 3 Serenta che indaga l'eRapa nella Poliposi Adenomatosa Familiare (FAP). Lo studio coinvolgerà inizialmente siti clinici in Danimarca, Germania, Paesi Bassi e Spagna, con l'Italia che sarà aggiunta successivamente.
L'azienda ha raggiunto diversi traguardi per il suo programma eRapa, tra cui la Designazione Fast Track della FDA, la designazione europea come farmaco orfano e l'avvio del primo sito clinico negli Stati Uniti. Il programma è supportato da una concessione di 20 milioni di dollari da CPRIT. Lo studio Serenta (NCT06950385) è progettato come uno studio di Fase 3 randomizzato, in doppio cieco e controllato con placebo, con l'inizio delle iscrizioni nei siti europei previsto per il quarto trimestre del 2025.
Biodexa Pharmaceuticals (NASDAQ:BDRX) ha presentado una Solicitud de Ensayo Clínico (CTA) ante la Agencia Europea de Medicamentos para su ensayo de Fase 3 Serenta que investiga eRapa en la Poliposis Adenomatosa Familiar (FAP). El ensayo cubrirá inicialmente sitios clínicos en Dinamarca, Alemania, Países Bajos y España, con Italia que se añadirá más adelante.
La compañía ha alcanzado varios hitos para su programa eRapa, incluyendo la Designación Fast Track de la FDA, la designación europea de medicamento huérfano y el inicio de su primer sitio clínico en EE.UU. El programa cuenta con el apoyo de una subvención de 20 millones de dólares de CPRIT. El ensayo Serenta (NCT06950385) está diseñado como un estudio de Fase 3 aleatorizado, doble ciego y controlado con placebo, con la expectativa de que los sitios europeos comiencen la inscripción en el cuarto trimestre de 2025.
Biodexa Pharmaceuticals (NASDAQ:BDRX)는 유럽 의약품청(EMA)에 가족성 선종성 용종증(FAP)을 대상으로 하는 eRapa의 3상 Serenta 임상시험 신청서(CTA)를 제출했습니다. 이 임상시험은 처음에 덴마크, 독일, 네덜란드, 스페인 임상 사이트를 포함하며, 이후 이탈리아가 추가될 예정입니다.
회사는 eRapa 프로그램과 관련하여 FDA 신속 심사 지정, 유럽 희귀의약품 지정, 미국 내 첫 임상 사이트 개설 등 여러 성과를 이루었습니다. 이 프로그램은 CPRIT로부터 2천만 달러의 보조금을 지원받고 있습니다. Serenta 임상시험(NCT06950385)은 무작위 배정, 이중맹검, 위약 대조 3상 연구로 설계되었으며, 유럽 사이트는 2025년 4분기에 등록을 시작할 예정입니다.
Biodexa Pharmaceuticals (NASDAQ:BDRX) a déposé une demande d'essai clinique (CTA) auprès de l'Agence européenne des médicaments pour son essai de Phase 3 Serenta, qui étudie l'eRapa dans la Polypose Adénomateuse Familiale (FAP). L'essai couvrira initialement des sites cliniques au Danemark, en Allemagne, aux Pays-Bas et en Espagne, l'Italie étant prévue ultérieurement.
La société a atteint plusieurs étapes importantes pour son programme eRapa, notamment la désignation Fast Track de la FDA, la désignation européenne de médicament orphelin, ainsi que le lancement de son premier site clinique aux États-Unis. Le programme bénéficie d'une subvention de 20 millions de dollars de CPRIT. L'essai Serenta (NCT06950385) est conçu comme une étude de Phase 3 randomisée, en double aveugle et contrôlée par placebo, avec un démarrage prévu des recrutements dans les sites européens au quatrième trimestre 2025.
Biodexa Pharmaceuticals (NASDAQ:BDRX) hat einen Antrag auf Durchführung einer klinischen Studie (CTA) bei der Europäischen Arzneimittelagentur für die Phase-3-Studie Serenta eingereicht, die eRapa bei Familiärer Adenomatöser Polyposis (FAP) untersucht. Die Studie wird zunächst klinische Standorte in Dänemark, Deutschland, den Niederlanden und Spanien umfassen, Italien soll später hinzugefügt werden.
Das Unternehmen hat mehrere Meilensteine für sein eRapa-Programm erreicht, darunter die Fast Track Designation der FDA, die europäische Orphan-Drug-Zulassung und den Start der ersten klinischen US-Studienstelle. Das Programm wird durch einen 20 Millionen Dollar Zuschuss von CPRIT unterstützt. Die Serenta-Studie (NCT06950385) ist als randomisierte, doppelblinde, placebokontrollierte Phase-3-Studie konzipiert, wobei die Einschreibung an den europäischen Standorten im vierten Quartal 2025 beginnen soll.
- None.
- 106-day approval timeline for CTA could delay European site enrollment
- Currently no treatment options for FAP except invasive surgery
Insights
Biodexa's CTA filing for eRapa represents significant advancement in their Phase 3 program for FAP, building on regulatory milestones and expanding internationally.
Biodexa's Clinical Trial Application filing with the European Medicines Agency represents a significant regulatory milestone for their Phase 3 Serenta trial investigating eRapa in Familial Adenomatous Polyposis (FAP). This development follows several important achievements including FDA Fast Track Designation, European Orphan Drug designation, and the initiation of their first US clinical site.
FAP is a critically underserved disease area with high unmet medical need - the condition almost invariably progresses to colorectal cancer if untreated, with current management limited to sequential surgical resection of the gastrointestinal tract. eRapa represents a potential non-surgical intervention for this rare inherited condition.
The CTA filing would enable trial expansion to multiple European countries including Denmark, Germany, Netherlands, and Spain initially, with Italy expected later. If approved following the standard 106-day review timeline, European enrollment could begin in Q4 2025.
Particularly noteworthy is the $20 million grant funding from CPRIT (Cancer Prevention and Research Institute of Texas) supporting this program, indicating significant external validation. The Phase 3 Serenta trial (NCT06950385) utilizes a rigorous randomized, double-blind, placebo-controlled design appropriate for a registrational study.
This filing positions Biodexa to advance a potentially transformative therapy addressing a life-threatening rare disease with substantial cancer risk, expanding their international clinical footprint beyond their already initiated US site which is actively screening participants.
July 14, 2025
Biodexa Announces Filing of CTA in Europe for Phase 3 Serenta Trial in
Familial Adenomatous Polyposis (FAP)
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, announced the filing of a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) for its Serenta trial 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 much of the gastrointestinal tract.
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, Netherlands and Spain with Italy expected to be added in due course.
Commenting, Stephen Stamp CEO and CFO of Biodexa said “Following Fast Track Designation by the FDA, Orphan Drug designation in Europe and initiation of our first clinical site in the US, the filing of our CTA with EMA is the latest in a series of important milestones for our eRapa Phase 3 program in FAP. Congratulations to our team, our collaborators at Emtora Biosciences and our European CRO, Precision for Medicine. This would not have been possible without the support of CPRIT which has awarded
The Serenta trial (NCT06950385) is a randomized, double-blind, placebo-controlled Phase 3 registrational study designed to evaluate the safety and efficacy of eRapa in patients diagnosed with FAP. The first site, in the US, is now open and actively screening eligible participants. Following the 106 day approval timeline for the CTA, it is expected the European sites will begin enrolling in the fourth quarter of this year.
For more information about the Serenta trial, including eligibility criteria and specific site location, 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 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.. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune®. 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.
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
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 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
What is the status of Biodexa's (BDRX) Phase 3 Serenta trial in Europe?
What designations has Biodexa's (BDRX) eRapa program received?
How much funding has CPRIT provided for Biodexa's (BDRX) FAP trial?
When will Biodexa (BDRX) begin enrolling patients in European clinical sites?
What type of study is the Biodexa (BDRX) Serenta trial?
