Clene announces plans to submit briefing book to U.S. FDA

Clene and its wholly owned subsidiary Clene Nanomedicine announced plans to submit a briefing book by July 13 to the U.S. Food and Drug Administration 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 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 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.