Clene Announces Plans To Submit Briefing Book To The U.S. FDA In Connection With Granted Type C Interaction To Obtain FDA Feedback On Potential Pathway To Accelerated Approval For CNM-Au8 In ALS

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 announced plans to submit a briefing book by July 13 to the U.S. Food and Drug Administration (FDA) in advance of a granted Type C interaction. The purpose of the interaction with the FDA, to occur in the third quarter of 2024, is to receive feedback on the potential path to submission of a new drug application (NDA) for CNM-Au8® as a potential treatment for ALS via the accelerated approval pathway.

 

Clene's briefing book contains new post-hoc analyses of data from completed clinical studies and is designed to address comments from the FDA made in a prior meeting announced publicly in December 2023, and in which Clene obtained feedback regarding the potential for accelerated approval. The briefing book contains additional analyses of neurofilament light (NfL) biomarker reduction, a more matured set of survival and functional benefit data, and additional evidence of CNM-Au8's potential mechanism of action, which Clene believes collectively support accelerated approval based on NfL reduction as a surrogate endpoint. Clene believes these new analyses serve to further demonstrate the potential for CNM-Au8 as a treatment in people living with ALS, consistent with the accelerated approval standards. Clene also included data addressing the agency's request to provide additional information concerning the relationship between CNM-Au8's proposed mechanism of action and reduction in NfL, as well as the association between observed NfL reductions and improved clinical outcomes in ALS patients, including survival.

Further insights into these new data analyses will be presented publicly later in 2024.

Clene plans to publicly announce the topline FDA feedback following the conclusion of the Type C interaction.