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.

About Clene

Clene is a clinical-stage biopharmaceutical company focused on the development of unique therapeutics for neurodegenerative diseases. Clene has innovated a novel nanotechnology drug platform for the development of a new class of orally administered neurotherapeutic drugs. Clene has also advanced into the clinic an aqueous solution of ionic zinc and silver for anti-viral and anti-microbial uses. Founded in 2013, the company is based in Salt Lake City, Utah with R&D and manufacturing operations located in North East, Maryland. For more information, please visit .

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Clene's actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "might" and "continues," and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant known and unknown risks and uncertainties, many of which are beyond Clene’s control and could cause actual results to differ materially and adversely from expected results. Factors that may cause such differences include Clene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Clene’s ability to achieve commercial success for its marketed products and drug candidates, if approved; Clene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Clene’s reliance on third parties to conduct drug development, manufacturing and other services; Clene’s limited operating history and its ability to obtain additional funding for operations and to complete the licensing or development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on Clene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in Clene’s recently filed registration statement on Form S-4, as well as discussions of potential risks, uncertainties, and other important factors in Clene’s subsequent filings with the U.S. Securities and Exchange Commission. Clene undertakes no obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

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Source: Clene Inc.