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Clene was awarded the four-year grant for the National Institute of Neurological Disorders and Stroke to support an Expanded Access Protocol for ALS drug.
Clene, a late clinical-stage biopharmaceutical company focused on treatments for neurodegenerative diseases, announced on Oct. 5, 2023 that it has been awarded a $45.1 million four-year grant by the National Institute of Neurological Disorders and Stroke (NINDS). The grant will support an Expanded Access Protocol (EAP) for Clene’s amyotrophic lateral sclerosis (ALS) drug, CNM-Au8. An EAP is an FDA-regulated pathway that allows people with a serious and life-threatening disease to access an investigational drug that is not yet approved by FDA. In addition, Clene will continue its ongoing ALS EAP programs.The grant is part of theAccelerating Access to Critical Therapies for ALS Act (ACT for ALS) that was signed into law on Dec. 23, 2021. The Act called for increased support for development and access to new ALS treatments.
Led by Jinsy A. Andrews, MD, MSc, FAAN, of Columbia University; Eric Anderson, MD, PhD,MBA, FAAN, of Synapticure; and Benjamin Greenberg, MD, MHS, FAAN, Head of Medical of Clene, the EAP will allow ALS patients to participate through Synapticure’s telemedicine neurology clinic and a network of nationwide clinics. “This study will monitor safety, survival, and clinical worsening as well as levels of key biomarkers related to disease progression with CNM-Au8 treatment,” according to the company.
“This EAP study will give ALS patients who don’t meet the criteria to enroll in a clinical trial an opportunity to try CNM-Au8 as a novel investigational therapy through this EAP program,” said Jinsy A. Andrews, M.D., MSc, FAAN, an associate professor of neurology in the Division of Neuromuscular Medicine and director of Neuromuscular Clinical Trials at Columbia University Vagelos College of Physicians and Surgeons, in a press release. “Programs like this help to advance research and much-needed innovation in ALS.”
"We are truly excited to be a part of this grant with Clene and Columbia and to support people living with ALS by providing access to treatments that could meaningfully impact the course of their disease. We are grateful to NINDS for recognizing how a virtual platform like Synapticure can provide expanded access programs in a remote capacity. It will allow us to reach people living with ALS across the U.S. who have not previously had access to investigational medicines, like CNM-Au8," said Dr. Anderson, VP of Clinical Operations and Care Delivery at Synapticure, in the release.
“Clene has demonstrated evidence of consistent safety and improved survival for CNM-Au8 across a broad ALS population in two independent Phase II trials and an ongoing EAP with up to 3.8 years of follow-up. This new EAP provides access to CNM-Au8 for more people living with ALS and enables the collection of survival, safety and biomarker data in a population not studied in clinical trials. These data can help provide confirmatory support for the existing trial data Clene has gathered in its clinical trials,” said Dr. Greenberg, in the release.