Benzinga | Feb 16, 2021 07:05AM EST

Clene Nanomedicine Initiates Phase 2 Study Of CNM-ZnAg For Patients With COVID-19

* Study to evaluate CNM-ZnAg in acutely symptomatic, non-hospitalized COVID-19 patients

SALT LAKE CITY, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) (along with its subsidiaries, "Clene") today announced that its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, received official ANVISA approval in Brazil to commence its multicenter, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of CNM-ZnAg liquid solution in a Phase 2 clinical study in acutely symptomatic, non-hospitalized COVID-19 patients. The primary endpoint will evaluate the rate of decreased hospitalizations at day 28, with secondary endpoints assessing time to symptom resolution. The trial is expected to enroll approximately 276 patients.

"In spite of vaccines recently becoming available, there remains a need for the development of therapeutics to treat symptomatic COVID-19 patients. COVID will remain a serious global health threat," said Rob Etherington, president and chief executive officer of Clene. "At Clene, we have always been committed to improving patient health. While our primary focus remains on delivering potentially transformative solutions for patients with neurodegenerative diseases, we brought forward our CNM-ZnAg development candidate to the clinic rapidly as we believe our technology could make a positive impact for symptomatic COVID patients."

CNM-ZnAg is a proprietary zinc-silver ionic solution that has demonstrated both antiviral and antibacterial properties in addition to boosting immune response. Participants in the Phase 2 study must have presented with two or more symptoms of acute COVID-19 infection within 96 hours prior to baseline visit, self-reported as moderate or severe. SARS-CoV-2 infection must be confirmed by polymerase chain reaction (PCR) testing within 96 hours prior to baseline visit. Patients enrolled in the study will be randomized 1:1:2 to receive either a low or high dose of ZnAg or placebo in a double-blind fashion, in addition to standard supportive care.

Enrollment in the trial is expected to be completed in mid-2021, with results now anticipated in the second half of 2021.