Clene Nanomedicine, Inc. Completes Enrollment in Rescue-ALS Clinical Trial for Treatment of Amyotrophic Lateral Sclerosis (ALS) with Lead Nanocatalytic Therapeutic, CNM-Au8

September 11, 2020

Clene Nanomedicine, Inc., (“Clene”) a clinical-stage biopharmaceutical company and its Australian subsidiary, Clene Australia Pty Ltd., on Tuesday announced the completion of patient enrollment in its RESCUE-ALS Phase 2 study. The multi-center study is designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in early symptomatic ALS patients. The objective of this study is to demonstrate improvements in muscle function using a sophisticated electromyography technique called Motor Unit Number Index (MUNIX). The trial is substantially funded by a grant from FightMND.

“Completing enrollment is a major milestone in our Phase 2 RESCUE-ALS trial. We are looking forward to unveiling the data expected in the summer of 2021. This key milestone could provide proof-of-concept for a novel nanotherapeutic agent for the treatment of ALS, and represents important advances for Clene,” said Rob Etherington, President and CEO of Clene.

“We applaud this significant step forward,” said Kelvyn Cullimore, president and CEO of BioUtah. “RESCUE-ALS is so much more than just a cinical trial. It represents hope and potential groundbreaking gains in the fight against this devastating disease.”

CNM-Au8 has demonstrated safety in Phase 1 studies and has shown both remyelination and neuroprotection effects in multiple preclinical models. CNM-Au8 is also currently being tested in a Phase 2 clinical study for patients with multiple sclerosis.