Clene provides update on expanded access program for CNM-Au8

Clene and its wholly-owned subsidiary Clene Nanomedicine announced several key updates on its National Institutes of Health-funded Accelerating Access to Critical Therapies Expanded Access Program for CNM-Au8 compassionate use in ALS. Late last year, in collaboration with Columbia University and Synapticure, Clene announced the award of a four-year grant from the National Institute of Neurological Disorders and Stroke, part of the NIH, to support an EAP for the Company’s investigational drug, CNM-Au8 in ALS. ALS is a deadly neurodegenerative disease with no known cure. In recognizing the need for accessibility and inclusion in such programs for individuals with ALS, Clene instituted significant manufacturing, operational, and personnel efficiencies to expand the program’s accommodation to up to 180 participants. In addition to meeting the requisite safety standards set by the FDA for all EAPs, Clene’s ACT-EAP was designed to contribute research results to the public understanding of ALS disease progression and response to therapy. To this end, the clinical teams at Clene, Columbia, and Synapticure designed the ACT-EAP for CNM-Au8 with the following additional objectives: To add ‘real-world’ drug exposure data to the growing clinical safety database on CNM-Au8; To assess ‘real-world’ drug efficacy data by monitoring potential drug effects on survival and disease progression with the use of natural history and control clinical trial database comparators. Biomarker data will also be collected and analyzed in parallel. First patient, first visit is planned for early June 2024; Enrollment has been expanded by 80% to a maximum of 180 participants; ‘Real-world’ drug efficacy data will be collected by monitoring potential drug effects on survival and disease progression, as well as safety