Clene: initial findings from the Phase 2 ALS programs insufficient to support accelerated approval

 Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today 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 Neurofilament Light Chain (NfL) biomarker results from the completed Phase 2 ALS studies. Clene also presented the evidence of long-term survival data from these studies as well as the supportive safety data of more than 500 years of participant exposure to date without any identified safety signals across ALS, MS, and Parkinson’s disease.

The FDA determined that the initial findings on biomarker NfL reduction from the Phase 2 programs 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. Clene plans to demonstrate how CNM-Au8’s mechanism of action is linked to the reduction in NfL, and the association between observed NfL reductions and improved clinical outcomes in ALS patients, including increased survival time.

https://www.globenewswire.com/news-release/2023/12/21/2799889/0/en/Clene-Provides-Update-on-ALS-Clinical-Development-Meeting-With-FDA.html