May 2021, Aalborg, Denmark
We continue to make rapid progress towards clinical trials of Mitometin, our novel drug targeting amyotrophic lateral sclerosis (ALS). A key milestone has been reached today as we have now completed preparation of the Clinical Development Plan (CDP) in collaboration with Worldwide Clinical Trials (Worldwide), our global CRO partner.
ALS is not only a disease with an enormous unmet medical need, but also an area with many regulatory developments that impact the clinical trial design. 2N Pharma selected Worldwide as the CRO for the ALS programme due to their extensive experience with ALS clinical trials. Armed with a fully developed CDP, we now have a clear understanding of the regulatory and clinical pathway for Mitometin.
“We are thrilled to be working with 2N Pharma on their ALS programme”, said Michael Murphy, MD, PhD, chief medical and scientific officer, for Worldwide. “With the CDP completed, we are now well-placed to proceed with the regulatory and clinical process when the time is right.”
Preben Bruun-Nyzell, CEO of 2N Pharma commented that “The CDP gives us confidence that our estimates for the cost and duration of the clinical programme is grounded in a thorough understanding of regulatory requirements and clinical convention”.
About 2N Pharma
2N Pharma is a biopharma company striving to develop breakthrough medications that are an effective treatment for currently incurable neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), Parkinson’s Disease (PD) and Multiple Sclerosis (MS).
2N Pharma was founded in 2019 to build on a decade of research undertaken by co-founder and CSO Dr. John Nieland and his associates. The company is based in Aalborg, Denmark and is part of the BioInnovation Institute (BII) in Copenhagen, an international initiative by the Novo Nordisk Foundation.
About Worldwide Clinical Trials
Worldwide Clinical Trials employs 2,000+ professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia-Pacific. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs – in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval, and real-world evidence, we provide world-class, full-service drug development services.
With infrastructure and talent spanning 60 countries, the company executes predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, general medicine, oncology, and rare diseases. For more information, visit www.worldwide.com.
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