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Clene Announces Completion of Patient Enrollment in the HEALEY ALS Platform Trial
Registration trial for CNM-Au8®, a gold nanocrystal suspensionTopline data anticipated 2H 2022World’s first ALS platform trial accelerating the path to new
About this update from Clene Inc.
[{"type":"text","content":"Registration trial for CNM-Au8®, a gold nanocrystal suspensionTopline data anticipated 2H 2022World’s first ALS platform trial accelerating the path to new ALS therapies SALT LAKE CITY, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) along with its subsidiaries “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease with potential first-in-class nanotherapeutics, today announced the completion of enrollment in the HEALEY ALS Platform Trial, led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital. Clene’s lead drug candidate, CNM-Au8®, a gold nanocrystal suspension, which has received U.S. Food and Drug Administration (FDA) Orphan Drug designation for the treatment of amyotrophic lateral sclerosis (ALS), is one of several drugs being evaluated in this innovative platform trial. “We are grateful to people living with ALS, whose support and participation have made possible the completion of this critical milestone for this first-of-its-kind platform trial. This achievement is pivotal for trial completion and result reporting, paving the way to continue groundbreaking research and find life-saving treatments for people with ALS,” said Merit Cudkowicz, MD, MSc, Principal Investigator and Sponsor of the HEALEY ALS Platform Trial, Director of the Sean M. Healey & AMG Center for ALS and chief of the Department of Neurology at Mass General, and the Julieanne Dorn Professor of Neurology at Harvard Medical School. “Having reached this significant milestone, we look forward to completing the 24-week, double-blind treatment phase and the release of top-line unblinded data in the second half of 2022. If CNM-Au8 meets its primary endpoint in this registration trial, we plan to file a New Drug Application with the FDA for disease-modification in ALS also in the second half of 2022. By catalyzing cellular energy metabolism, we believe CNM-Au8 may improve outcomes for ALS patients who currently have few treatment options,” said Robert Glanzman, MD, Chief Medical Officer of Clene. The HEALEY ALS Platform Trial is a multi-center clinical program evaluating the safety and efficacy of multiple investigational products in ALS patients. It is the first ever platform trial implemented in ALS and ...