Biodexa Announces Appointment of Precision for Medicine LLC as CRO for European Component of Phase 3 Study of eRapa in FAP
Biodexa Pharmaceuticals (Nasdaq: BDRX) has appointed Precision for Medicine, as the clinical research organization (CRO) for the European component of its upcoming Phase 3 study of eRapa in Familial Adenomatous Polyposis (FAP). The U.S. component will be managed by LumaBridge in San Antonio, Texas.
The Phase 3 registrational study is designed as a double-blind placebo-controlled trial involving 168 patients, with a 2:1 drug/placebo randomization ratio. The study will be conducted across approximately 30 clinical sites in the US and Europe, with initiation planned for next quarter.
Precision, specializing in rare diseases, brings over 20 years of experience with 333 clinical trials in rare diseases and employs more than 700 team members across 11 European locations.
Biodexa Pharmaceuticals (Nasdaq: BDRX) ha nominato Precision for Medicine come l'organizzazione di ricerca clinica (CRO) per la componente europea del suo prossimo studio di Fase 3 su eRapa nella Poliposi Adenomatosa Familiare (FAP). La componente statunitense sarà gestita da LumaBridge a San Antonio, Texas.
Lo studio registrativo di Fase 3 è progettato come uno studio clinico in doppio cieco, controllato con placebo, che coinvolgerà 168 pazienti, con un rapporto di randomizzazione farmaco/placebo di 2:1. Lo studio sarà condotto in circa 30 siti clinici negli Stati Uniti e in Europa, con inizio previsto per il prossimo trimestre.
Precision, specializzata in malattie rare, porta oltre 20 anni di esperienza con 333 studi clinici in malattie rare e impiega più di 700 membri del team in 11 sedi europee.
Biodexa Pharmaceuticals (Nasdaq: BDRX) ha nombrado a Precision for Medicine como la organización de investigación clínica (CRO) para el componente europeo de su próximo estudio de Fase 3 sobre eRapa en la Poliposis Adenomatosa Familiar (FAP). El componente estadounidense será gestionado por LumaBridge en San Antonio, Texas.
El estudio registrativo de Fase 3 está diseñado como un ensayo doble ciego controlado con placebo que involucra a 168 pacientes, con una relación de aleatorización de 2:1 entre medicamento/placebo. El estudio se llevará a cabo en aproximadamente 30 sitios clínicos en EE. UU. y Europa, con inicio previsto para el próximo trimestre.
Precision, especializada en enfermedades raras, aporta más de 20 años de experiencia con 333 ensayos clínicos en enfermedades raras y emplea a más de 700 miembros del equipo en 11 ubicaciones europeas.
Biodexa Pharmaceuticals (Nasdaq: BDRX)는 Precision for Medicine을 가족성 선종성 용종증(FAP)에 대한 eRapa의 다가오는 3상 연구의 유럽 구성 요소를 위한 임상 연구 조직(CRO)으로 임명했습니다. 미국 구성 요소는 텍사스주 샌안토니오에 있는 LumaBridge가 관리합니다.
3상 등록 연구는 168명의 환자를 포함하는 이중 맹검 위약 대조 시험으로 설계되었으며, 약물/위약 무작위 배정 비율은 2:1입니다. 이 연구는 미국과 유럽의 약 30개 임상 사이트에서 진행될 예정이며, 다음 분기에 시작될 예정입니다.
희귀 질환을 전문으로 하는 Precision은 희귀 질환에 대한 333개의 임상 시험에서 20년 이상의 경험을 보유하고 있으며, 11개의 유럽 위치에서 700명 이상의 팀원을 고용하고 있습니다.
Biodexa Pharmaceuticals (Nasdaq: BDRX) a nommé Precision for Medicine comme organisation de recherche clinique (CRO) pour le volet européen de sa prochaine étude de Phase 3 sur eRapa dans la Polypose Adenomateuse Familiale (FAP). Le volet américain sera géré par LumaBridge à San Antonio, Texas.
L'étude d'enregistrement de Phase 3 est conçue comme un essai en double aveugle contrôlé par placebo impliquant 168 patients, avec un ratio de randomisation médicament/placebo de 2:1. L'étude sera réalisée dans environ 30 sites cliniques aux États-Unis et en Europe, avec un début prévu pour le trimestre prochain.
Precision, spécialisée dans les maladies rares, apporte plus de 20 ans d'expérience avec 333 essais cliniques dans les maladies rares et emploie plus de 700 membres d'équipe dans 11 sites en Europe.
Biodexa Pharmaceuticals (Nasdaq: BDRX) hat Precision for Medicine als klinische Forschungsorganisation (CRO) für den europäischen Teil seiner bevorstehenden Phase-3-Studie zu eRapa bei familiärer adenomatöser Polyposis (FAP) ernannt. Der US-amerikanische Teil wird von LumaBridge in San Antonio, Texas, geleitet.
Die registrierende Phase-3-Studie ist als doppelblinde, placebo-kontrollierte Studie mit 168 Patienten konzipiert, mit einem Randomisierungsverhältnis von 2:1 für Medikament/Placebo. Die Studie wird an etwa 30 klinischen Standorten in den USA und Europa durchgeführt, mit einem geplanten Beginn im nächsten Quartal.
Precision, spezialisiert auf seltene Erkrankungen, bringt über 20 Jahre Erfahrung mit 333 klinischen Studien zu seltenen Erkrankungen mit und beschäftigt mehr als 700 Teammitglieder an 11 europäischen Standorten.
- Phase 3 trial initiation planned for next quarter
- Large-scale study with 168 patients across 30 sites
- Experienced CROs appointed for both US and EU regions
- None.
March 6, 2025
Biodexa Announces Appointment of Precision for Medicine LLC as CRO for European Component of Phase 3 Study of eRapa in FAP
Biodexa is finalizing plans to initiate an international Phase 3 registrational
study of eRapa in Familial Adenomatous Polyposis (FAP) next quarter
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, today announced the appointment of Precision for Medicine, LLC (“Precision”) as the clinical research organization (“CRO”) to conduct the European component of the upcoming registrational Phase 3 study of eRapa in FAP. The U.S. component of the study will be conducted by LumaBridge, based in San Antonio, Texas.
The planned registrational Phase 3 study of eRapa in FAP will be a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo. It is expected the study will be conducted in approximately 30 clinical sites across the US and Europe.
Focused on rare diseases, Precision was formed with a mission to accelerate the pathway for complex drug development. With over 20 years of experience, Precision’s reputation is founded on its high-calibre, therapeutically specialized staff, experienced scientists and physicians, advanced specialty laboratories, and problem-solving capabilities. Precision has conducted 333 clinical trials in rare diseases and employs over 700 team members in Europe across 11 locations.
About eRapa
eRapa is a proprietary oral tablet 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. Compelling six month data from a Phase 2 study of eRapa in FAP were presented at Digestive Disease Week in April 2024 and 12 month data were presented at InSIGHT, Barcelona in June 2024.
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 Blader 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 tablet 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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