Clinical Trial of Nanocrystalline Gold for Amyotrophic Lateral Sclerosis Completes Double-Blinded Phase

All patient visits have been completed in the phase 2 study (NCT04098406) of catalytically active gold nanocrystals (Clene Nanomedicine, Salt Lake City, UT) for early-stage amyotrophic lateral sclerosis (ALS). Topline results are anticipated in the fourth quarter of 2021. 

Earlier interim analysis of study data showed that 18% of those treated with nanocrystalline gold had improvement on the Motor Unit Number Index (MUNIX), compared with the expected continuous decline seen in prior observational studies. Decreased decline of forced vital capacity was also observed. Notably, 90% of eligible participants have elected to continue treatment in an open-label extension period. 

“Our clinical trial teams in Sydney are very pleased to have reached this important landmark for RESCUE-ALS. It is a tribute to the (participants with) ALS involved in the trial that we were able to recruit for the trial throughout the COVID-19 pandemic. (People with ALS) have shown great resilience and a willingness to contribute to research and discovery. Now, like them, we look forward to the trial analysis and outcomes,” said Professor Matthew Kiernan, AM MBBS(Hons), PhD, DSc, FRACP, FAHMS, Bushell Chair of Neurology, University of Sydney.

Participants (n=45) were randomized 1:1 to receive either active treatment with CNM-Au8 (30mg) or placebo in addition to their current standard of care over a 36-week treatment period.