Clene Nanomedicine Inc., a wholly owned subsidiary of Salt Lake City-based Clene Inc., has received 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.
Received in collaboration Columbia University and Chicago-based Synapticure, the award is for the development of an Expanded Access Protocol (EAP) for the company’s investigational drug, CNM-Au8, for the treatment of 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 company said.
The EAP grant is part of the Accelerating Access to Critical Therapies for ALS Act passed by Congress in December 2021. The act calls 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 Dr. Jinsy A. Andrews of Columbia University; Dr. Eric Anderson of telehealth platform Synapticure; and Dr. Benjamin Greenberg, head of medical at Clene.
“Clene has demonstrated evidence of consistent safety and improved survival for CNM-Au8 across a broad ALS population in two independent Phase 2 trials and an ongoing EAP with up to 3.8 years of follow-up,” said Greenberg.
Clene is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including ALS, Parkinson’s disease and multiple sclerosis.