Clene announces FDA said NfL reduction insufficient for accelerated approval

Clene and its wholly owned subsidiary Clene Nanomedicine 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. 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.