MediciNova Partners with NIH for ALS Trial Using MN166
MediciNova’s Collaboration with NIH on ALS Clinical Trial
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (JPX: 4875), has made a significant move towards supporting initiatives in neurodegenerative disease research. It recently announced that it will partner with the National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS) for an Expanded Access Protocol (EAP) to evaluate MJN-166, also known as ibudilast, in the context of Amyotrophic Lateral Sclerosis (ALS).
Funding and Purpose of the Trial
The NIH has dedicated $22 million towards this EAP trial, which aims to explore the efficacy of MN-166 (ibudilast) for individuals experiencing ALS symptoms who are unfortunately ineligible to participate in the ongoing COMBAT-ALS trial. This pathway will allow patients access to this investigational drug while simultaneously collecting valuable neurobiological and clinical data that could shape future treatments.
Expanded Access Protocol (EAP)
Expanded Access, often referred to as Compassionate Use, enables individuals with serious conditions to obtain treatments that have yet to receive FDA approval. The trial aims to not only provide more options for ALS patients but also to further understand the underlying mechanisms of the disease through the use of biomarkers like neurofilament light, indicative of neuron damage.
CEO's Statement on the Initiative
Dr. Yuichi Iwaki, MediciNova’s President and CEO, highlighted the importance of this grant and collaboration for advancing ALS research. He expressed gratitude towards the NIH and NINDS for their commitment to improving the lives of those affected by this life-threatening condition as well as appreciation for the dedication of healthcare providers, patients, and their families involved in the study.
Overview of MN-166 (ibudilast)
MN-166 (ibudilast) is an innovative orally available compound known for its ability to inhibit phosphodiesterase type-4 (PDE4) and reduce inflammatory cytokines, including macrophage migration inhibitory factor (MIF). Currently, this promising molecule is in late-stage development targeting several neurodegenerative diseases, including ALS, progressive multiple sclerosis, and degenerative cervical myelopathy (DCM). Additionally, research into MN-166's effects extends to glioblastoma, Long COVID, and substance use disorder.
Orphan Drug Designation and Future Developments
MediciNova has gained Orphan Drug Designation for MN-166 in ALS from the U.S. FDA and the EU EMA. The drug has been awarded Fast Track Designation for its potential use in ALS treatment and is on a promising path, with ongoing trials that explore its efficacy across a variety of conditions. The dedication to both drug safety and innovative treatment shows MediciNova's commitment to addressing the rising challenges in chronic disease management.
MediciNova’s Broader Mission
As a clinical-stage biopharmaceutical entity, MediciNova aims to develop a diverse pipeline of novel small molecule therapies focused on inflammatory, fibrotic, and neurodegenerative conditions. With strong foundations in research and clinical success through its lead asset MN-166, the company’s aspirations extend towards addressing critical needs in developing essential therapies that have lasting impacts on patients' lives.
Frequently Asked Questions
What is MN-166 (ibudilast) used for?
MN-166 is being investigated for treating ALS, progressive multiple sclerosis, and other neurodegenerative diseases, aiming to alleviate symptoms and improve patient outcomes.
How is the NIH involved in the clinical trial?
The NIH has awarded MediciNova $22 million to support the EAP trial, allowing ALS patients to receive MN-166 despite being ineligible for the COMBAT-ALS trial.
What are the main goals of the Expanded Access Protocol?
The EAP aims to provide access to MN-166 for ALS patients while gathering critical clinical data that can enhance understanding of the disease and treatment efficacy.
Who is leading the clinical trial?
MediciNova is collaborating with an academic group to lead the EAP trial, providing investigational drug, regulatory and safety monitoring support.
What designation has MN-166 received?
MN-166 has received Orphan Drug Designation from both the U.S. FDA and EU EMA for its potential use in treating ALS, which facilitates expedited development and review processes.
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