Biodexa Pharmaceuticals Enhances Phase 3 Study with New CRO
Biodexa Pharmaceuticals Enhances Research with New CRO
Biodexa Pharmaceuticals PLC has made a significant move in the realm of biopharmaceutical development by appointing Precision for Medicine LLC as the clinical research organization (CRO) for the European component of its Phase 3 study of eRapa, targeting Familial Adenomatous Polyposis (FAP). This decision marks a crucial step toward initiating this essential trial, which aims to assess the efficacy of eRapa in treating this rare genetic condition.
Overview of the Phase 3 Study
This upcoming registrational Phase 3 study of eRapa is set to unfold as a double-blind, placebo-controlled trial involving 168 patients. Participants will be randomized in a 2:1 ratio, receiving either the drug or a placebo. The study is expected to be held across approximately 30 clinical sites in both the US and Europe, opening new avenues for research in FAP.
Precision for Medicine's Role
Precision for Medicine is well-suited for this role, boasting over 20 years of expertise focused on accelerating complex drug development, particularly in the field of rare diseases. Their extensive experience includes conducting over 333 clinical trials, and they house a specialized team of more than 700 professionals across Europe, committed to addressing the unique challenges of rare diseases.
Understanding eRapa
eRapa is an innovative oral formulation of rapamycin, also known as sirolimus. This drug functions as an mTOR (mammalian target of rapamycin) inhibitor. The mTOR pathway plays an essential role in regulating cellular processes including growth and metabolism, and its overexpression is notably linked to the formation of FAP polyps. With eRapa, Biodexa aims to provide a potent and safe treatment option for patients battling FAP.
Supporting Data and Studies
Recent compelling data from a Phase 2 study demonstrated the potential of eRapa in treating FAP, with impressive six-month results shared at a prominent digestive disease conference. Long-term outcomes were also discussed at an influential medical gathering, further substantiating eRapa’s promise as a groundbreaking treatment.
About Biodexa Pharmaceuticals
Biodexa Pharmaceuticals PLC, listed on NASDAQ under the ticker BDRX, is committed to addressing unmet medical needs through its innovative treatment pipeline. The company’s lead projects include eRapa for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, along with tolimidone for type 1 diabetes and MTX110 for rare brain cancers.
Innovative Drug Delivery Technologies
At the core of Biodexa's offerings are proprietary drug delivery technologies that enhance the bioavailability and distribution of medicines. The company's operations and research and development activities are centered in Cardiff, UK, where a robust infrastructure supports cutting-edge biomedical research and innovation.
Future Directions
Biodexa’s collaboration with Precision for Medicine marks a critical juncture in the development of eRapa and its journey through clinical trials. As the study progresses, the company aims to deliver not only promising results but also hope for many patients impacted by rare illnesses.
Frequently Asked Questions
What is eRapa?
eRapa is an oral formulation of rapamycin, designed to treat conditions like Familial Adenomatous Polyposis by inhibiting the mTOR pathway.
Who is conducting the Phase 3 study?
The European component of the Phase 3 study is being conducted by Precision for Medicine, a specialized clinical research organization.
How many patients are involved in the study?
The study involves 168 patients, who will be randomly assigned to receive either eRapa or a placebo.
Where will the clinical trials take place?
The trials are set to occur across approximately 30 clinical sites in both the US and Europe.
What other projects is Biodexa working on?
Biodexa is also developing tolimidone for type 1 diabetes and MTX110 for rare brain cancer, showcasing a diverse pipeline of innovative treatments.
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