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National Institutes of Health Awards $45.1 Million NINDS Grant for CNM-Au8® Study in ALS
Funding to Support Research and Expanded Access of Investigational Drug in ALS SALT LAKE CITY, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN),
About this update from Clene Inc.
[{"type":"text","content":"Funding to Support Research and Expanded Access of Investigational Drug in ALS\nSALT LAKE CITY, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN), through its wholly owned subsidiary Clene Nanomedicine Inc. in collaboration with Columbia University and Synapticure, has been awarded a four-year grant totaling $45.1 million from the National Institute of Neurological Disorders and Stroke (NINDS), a division of the National Institutes of Health (NIH), to support an Expanded Access Protocol (EAP) for the Company’s investigational drug, CNM-Au8®, in amyotrophic lateral sclerosis (ALS). An EAP is also referred to as Compassionate Use and 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 the U.S. Food and Drug Administration (FDA). In addition to this new EAP, Clene will continue to conduct its currently ongoing ALS EAP programs that have enrolled more than 200 participants since 2019. The EAP grant is part of the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS). This Act was overwhelmingly supported by Congress and signed into law by President Biden on Dec. 23, 2021, with a call for increased support of public-private partnerships that will innovate the development of, and increase access to, potential new treatments for ALS. The EAP study will be 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. This EAP will provide eligible people living with ALS to work with their clinician to access CNM-Au8. The EAP is designed to enable the participation of people living with ALS from all 50 states, including remote and rural areas, through Synapticure’s telemedicine neurology clinic as well as 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. “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 direc...