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Clene Nanomedicine Announces Achievement of 50% Enrollment in the Phase 3 HEALEY ALS Platform Trial
World’s first ALS platform trial led by Mass General Hospital and conducted at NEALS centers throughout the United States is a registration trial SALT LAKE
About this update from Clene Inc.
[{"type":"text","content":"World’s first ALS platform trial led by Mass General Hospital and conducted at NEALS centers throughout the United States is a registration trial\nSALT LAKE CITY, March 09, 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 dedicated to revolutionizing the treatment of neurodegenerative disease using nanocatalysis, today announced that over 50% of participants have been enrolled in the HEALEY ALS Platform Trial being conducted at sites of the Northeast ALS (NEALS) consortium. The HEALEY ALS Platform trial is a multi-center trial evaluating the safety and efficacy of multiple investigational products in amyotrophic lateral sclerosis (ALS) patients. It is the first ever ALS platform trial and was designed with a shared placebo arm to reduce trial time, reduce costs, and increase patient participation in developing novel therapies for ALS. It includes substantial financial support from philanthropic donors and foundations and is being implemented at up to 54 expert ALS clinical trial sites across the U.S. Clene’s lead drug candidate CNM-Au8, a bioenergetic nanocatalyst, was selected by the Healey Center Therapy Selection Committee to be one of the first entrants into the trial. In the Clene, CNM-Au8 treatment regimen, a total of 160 participants are randomized 3:1 (active:placebo), with 120 randomized across two active arms (CNM-Au8 30 mg and 60mg) and 40 in placebo. Clinical data from an additional 80 placebo-treated participants are shared within the platform trial from two other regimens for an overall 1:1 allocation of active:placebo. “Clene was honored to have CNM-Au8 chosen as one of the first drug regimens to be evaluated in the HEALEY Platform trial, and we are excited to achieve this enrollment milestone,” said Robert Glanzman, MD, chief medical officer of Clene. “This trial is a testament to the excellence and hard work of our collaborators at the Sean M. Healey & AMG Center for ALS at Mass General, the research capabilities of the NEALS clinical sites, outstanding patient and caregiver support, and the dedication of our Clene colleagues in supporting this landmark study.” About CNM-Au8 Clene’s lead drug candidate, CNM-Au8, a bioenergetic nanocatalyst, is a stable, aqueous suspension ...