Insights

Clene Inc. and its subsidiary, Clene Nanomedicine Inc., are set to meet with the U.S. Food and Drug Administration (FDA) by the end of November 2024 to discuss the development of CNM-Au8 for treating amyotrophic lateral sclerosis (ALS). This meeting will involve key FDA officials, including the Director of the Office on New Drugs and the Division of Neurology 1 review team, as well as experts in ALS and biostatistics. The FDA had previously indicated that Clene's briefing package did not support a New Drug Application (NDA) submission under the accelerated approval pathway. However, following further discussions, the FDA agreed to reassess Clene's submission in person. Clene has gathered over 700 patient-years of safety data for CNM-Au8, which is an oral suspension of gold nanocrystals designed to enhance mitochondrial health and protect neuronal function. The data collected so far has not revealed significant safety concerns or serious adverse events related to the treatment. The company aims to present its findings on ALS biomarkers, clinical endpoints, and survival data during the upcoming meeting, which it believes are crucial for understanding the potential of CNM-Au8. The meeting represents a critical opportunity for Clene to engage directly with FDA leadership and address any questions regarding its drug candidate. The outcome of this interaction could significantly influence the future development and potential approval of CNM-Au8 for ALS treatment. Clene's focus on neurodegenerative diseases highlights the importance of innovative therapies in addressing unmet medical needs. As the company prepares for this pivotal meeting, it remains committed to demonstrating the efficacy and safety of its drug candidates. The results of this engagement with the FDA will be closely watched by stakeholders in the biopharmaceutical industry, as they could set the stage for future advancements in ALS treatment.