- Clene announced significant updates to their NIH-funded Accelerating Access to Critical Therapies Expanded Access Program (ACT-EAP) for CNM-Au8(R) compassionate use in amyotrophic lateral sclerosis (“ALS”)
- Clene has optimized its manufacturing, operational, and personnel processes to expand the program’s capacity to accommodate up to 180 participants
- The ACT-EAP, a collaboration among Clene, Columbia University, and Synapticure, was funded by the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS), signed into law by Congress and President Biden in December 2021
Clene (NASDAQ: CLNN) and its subsidiary, Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company dedicated to improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases such as ALS and multiple sclerosis (“MS”), recently announced significant updates to their ACT-EAP for CNM-Au8 compassionate use in ALS (https://ibn.fm/aBWxl).
ALS is a fatal neurodegenerative disease with no known cure, making accessibility to treatment programs crucial. Recognizing this need, Clene has optimized its manufacturing, operational, and personnel processes to expand the program’s capacity to accommodate up to 180 participants.
In collaboration with Columbia University and Synapticure, Clene has secured a four-year grant totaling around $45m from the National Institute of Neurological Disorders and Stroke (“NINDS”), part of the NIH, to support an Expanded Access Program (“EAP”) for their investigational drug CNM-Au8 in ALS.
EAPs, also known as compassionate use programs, are FDA-regulated pathways that allow individuals with serious and life-threatening diseases to access investigational drugs not yet approved by the Food and Drug Administration. Funding for EAPs in ALS was strengthened by the ACT for ALS, signed into law by Congress and President Biden in December 2021.
Rob Etherington, CEO of Clene, said CNM-Au8 treatment has been associated with lowered risk of death and delayed clinical worsening, while being very well-tolerated in both of the company’s independent Phase 2 clinical studies. “Data from EAP programs, which usually include a broader ALS population than clinical trials, can supplement the safety and other meaningful data gathered from clinical studies,” Etherington added. “We are grateful for the NIH’s recognition to fund this important initiative and are pleased to provide this EAP for the ALS community. We are also grateful to the FDA for approving this EAP, working alongside Columbia University and Synapticure, to enable people who are living with this devastating disease access to our investigational drug CNM-Au8.”
Clene’s ACT-EAP is designed not only to meet FDA safety standards for EAPs but also to contribute valuable research data on ALS disease progression and therapy response. The program’s additional objectives include collecting real-world drug exposure data to enhance the CNM-Au8 clinical safety database and monitoring drug efficacy on survival and disease progression using natural history and control clinical trial database comparators. Biomarker data will also be collected and analyzed. This study is supported by the NIH under grant 1U01NS136023-01.
Dr. Jinsy A. Andrews, MD, MSc, FAAN, of Columbia University, and Principal Investigator on the grant, underscored that this was not just a standard EAP, in which Clene provides the investigational product to individuals with ALS through an FDA-regulated program. “A lot of time, careful thought, and effort have resulted in a study that will yield important insights into the real-world impact of CNM-Au8 treatment on the disease course of ALS,” Andrews explained.
The first patient visit for the ACT-EAP is scheduled for June 2024.
For more information, visit the company’s website at www.Clene.com.
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN
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