Clene Inc. and its subsidiary Clene Nanomedicine Inc. have recently announced plans to submit a briefing book to the U.S. Food and Drug Administration (FDA) in connection with a granted Type C interaction. The purpose of this interaction, scheduled for the third quarter of 2024, is to obtain feedback from the FDA on the potential path to accelerated approval for their drug candidate, CNM-Au8, as a treatment for amyotrophic lateral sclerosis (ALS).
Accelerating Access to Critical Therapies Expanded Access Program (ACT-EAP)
In addition to the briefing book submission plans, Clene Inc. has provided key updates on its National Institutes of Health (NIH)-funded ACT-EAP for CNM-Au8 compassionate use in ALS. The company, focused on improving mitochondrial health and protecting neuronal function for neurodegenerative diseases, including ALS and multiple sclerosis (MS), aims to provide critical therapies to patients through this expanded access program.
Rob Etherington’s Appearance on From Lab to Launch
Rob Etherington, the President, Director, and CEO of Clene Inc. recently appeared on the From Lab to Launch podcast, hosted by IBN. The podcast shares inspiring stories of founders, investors, scientists, engineers, and pioneers in the life sciences sector. Etherington’s appearance reflects Clene’s commitment to advancing innovative therapies and their dedication to making a difference in the field of neurodegenerative diseases.
Conclusion:
Clene Inc. and its subsidiary Clene Nanomedicine Inc. are actively pursuing the accelerated approval pathway for their drug candidate CNM-Au8 in the treatment of ALS. By submitting a briefing book to the FDA, they seek feedback and guidance on the potential path to an accelerated approval process. Simultaneously, their NIH-funded ACT-EAP for CNM-Au8 in ALS aims to provide critical therapies to patients in need. These developments demonstrate Clene’s dedication to improving mitochondrial health and protecting neuronal function to combat neurodegenerative diseases.
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