Clene (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., today announced new data from the 12-month long-term open label extension (“OLE”) of the CNM-Au8(R) treatment arm in the HEALEY ALS Platform Trial. A key biomarker of neurodegeneration, Neurofilament Light Chain (“NfL”) is released from neurons following axonal injury, especially in people living with ALS, where higher levels of NfL have been found to predict more rapid decline in clinical function and increased mortality risk. As detailed in the announcement, CNM-Au8 30mg treatment reduced plasma NfL levels compared to baseline. “As consensus is building that neurofilament is an important biomarker reasonably likely to predict clinical benefit, it is important to see NfL continue to decrease during long-term follow-up, and correlate with time to event clinical outcomes in the Clene regimen of the double-blind and OLE portions of the HEALEY ALS Platform Trial,” said James D. Berry MD. Dr Berry is associate professor of neurology, chief of the motor neuron disorder division and director of the Neurological Clinical Research Institute at Massachusetts General Hospital.
The company also provided an ALS regulatory update from its recent meeting with the U.S. Food and Drug Administration (“FDA”). Clene met with the FDA to discuss CNM-Au8 for the treatment of ALS, presenting initial clinical and NfL biomarker results from completed phase 2 ALS studies and evidence of long-term survival data from these studies as well as supportive safety data. The FDA determined that the initial findings were insufficient to support accelerated approval at this time. Clene is looking forward to providing supplemental data for further engagement with the FDA in the first half of 2024, including additional long-term clinical evidence and biomarker results of CNM-Au8’s treatment benefit in people living with ALS. “As we continue to analyze the data from our phase 2 clinical program, we believe the evidence supports that CNM-Au8 treatment improved survival in people living with ALS,” said Benjamin Greenberg, M.D., Clene’s head of medical. “We are also encouraged that the recently disclosed long-term NfL biomarker decreases are consistent with delayed clinical time-to-event outcomes.”
About Clene Inc.
Clene (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease and multiple sclerosis. CNM-Au8(R) is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8(R) is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.Clene.com.
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