First Participant Dosed in Phase 2 Study of Nanocatalytic Gold for Amyotrophic Lateral Sclerosis 

Enrollment has been completed and the first participant dose has occurred in the phase 2 Rescue-ALS study (NCT04098406). This trial is a nanocatalytic gold therapy (CNM-Au8, Clene, Salt Lake City, UT) for the treatment of amyotrophic lateral sclerosis (ALS).

"The objective of the randomized double-blind Rescue-ALS study is to demonstrate that improvements in brain bioenergetic cellular support in early symptomatic ALS patients treated with CNM-Au8 will help preserve motor neurons survival and function. The primary endpoint is the mean change in the average difference between active treatment and placebo from baseline through week 36 for the motor unit number index (MUNIX) score, which quantitatively reflects the loss of motor neurons in ALS—the primary cause of clinical progression in ALS," said Robert Glanzman, MD, FAAN, Clene's chief medical officer.

"We are excited to advance CNM-Au8 clinically into this phase 2 study for ALS patients," said Rob Etherington, president and CEO of Clene. "As neurodegenerative diseases such as ALS have very few treatment options, this study will prove whether CNM-Au8 may be an effective disease-modifying treatment for people with ALS."  

"We are very excited to partner with Clene on the phase 2 study in ALS, Rescue-ALS," said professor Steve Vucic, director of Neurophysiology, Department of Neurology, at Sydney Medical School, Westmead Hospital. "CNM-Au8 offers an innovative approach of potentially treating neurodegenerative diseases, such as ALS, for which there are no effective treatments at present. We are hopeful that CNM-Au8 will be an effective therapy in the future and this trial will go a long way in addressing this question."