Clene Misses Topline in Phase 2 COVID-19 Study

 

• Primary endpoint of time to substantial symptom resolution was not met in acutely symptomatic, non-hospitalized COVID-19 patients
  

• CNM-ZnAg treatment was safe and well-tolerated

Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company today announced topline study results from its Phase 2 investigational trial with CNM-ZnAg, an ionic solution of zinc and silver, for the treatment of non-hospitalized acutely symptomatic participants infected with COVID-19.

The Phase 2 multicenter, randomized, double-blind, placebo-controlled trial assessed the efficacy and safety of CNM-ZnAg in COVID-19 infected participants in Brazil. Study participants were randomized 1:1:2 to receive daily low dose CNM-ZnAg, high dose CNM-ZnAg, or placebo in addition to standard supportive care for up to 21 days. The primary endpoint assessed the time to substantial alleviation of COVID-19 symptoms through 28 days, confirmed over a continuous period ≥ 48 hours, in the modified intent-to-treat (mITT) population (all participants with PCR documented SARS-CoV-2 infection, n=288). No clinical benefit was observed versus placebo. CNM-ZnAg was safe and well-tolerated, and no safety signals were identified.

Rob Etherington, Clene’s CEO, commented, “While COVID has not been a therapeutic focus of the company, we were compelled to explore the potential of CNM-ZnAg to help address the global pandemic. At this time, we will cease further development for COVID. We are heartened by the safety profile of CNM-ZnAg, the second asset developed through our technology platform, and its future potential in other antiviral and antibacterial areas. We continue our focus on treatment of neurodegenerative diseases with our lead asset, CNM-Au8, which is advancing towards registrational trials.”

https://finance.yahoo.com/news/clene-nanomedicine-reports-topline-results-210100825.html