Core Insights - Clene Inc. has entered into an agreement with APST Research GmbH to utilize its NfL database for FDA-recommended analyses of CNM-Au8's effect on neurofilament light chain (NfL) decline in ALS patients [1][4][6] Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company focused on treating neurodegenerative diseases, including ALS and MS, through its investigational therapy CNM-Au8 [7][8] - CNM-Au8 is designed to improve mitochondrial health and neuronal function, targeting oxidative stress and enhancing energy production [8][11] Collaboration with APST Research - APST Research maintains a comprehensive ALS database, including data from over 4,300 ALS patients, which will support Clene's analysis of NfL changes [2][3] - The collaboration aims to provide a robust statistical analysis plan for NfL evaluations in NIH-sponsored Expanded Access Protocols (EAPs) [2][4] Clinical Data and Analysis - Clene's analysis will include data from more than 1,625 ALS patients, correlating NfL biomarker data with clinical assessments and events [3][4] - The objective is to demonstrate that NfL change rates are associated with survival in ALS patients, potentially supporting the NDA submission for CNM-Au8 [3][4] Real-World Evidence Collection - Clene has treated nearly 500 ALS patients through its EAP programs to gather Real-World Evidence (RWE) on CNM-Au8's effects [4][5] - Positive results from the NfL reduction analysis could support the planned New Drug Application (NDA) for CNM-Au8, expected in the second half of 2025 [4][6] Safety Profile - Over 800 participant years of treatment with CNM-Au8 have not revealed significant safety concerns or serious adverse events related to the treatment [5]
Clene and APST Enter Into an Agreement to Support FDA’s Recommendation for Long-Term NfL Biomarker Analyses of CNM-Au8®’s Impact on NfL Reduction