SAN DIEGO, March 16, 2021 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ:HSTO) and Amerimmune LLC today announced dosing the first patient in a Phase 1 study of emricasan in mild symptomatic -COVID-19 patients to assess safety, tolerability, and preliminary efficacy. SUNY Downstate Medical Center in Brooklyn, New York, has been selected as the single site for the study conduct.
This double blinded, 1:1 randomized, placebo controlled single site study is expected to enroll 40 symptomatic mild-COVID-19 patients in an outpatient setting using emricasan at 25mg BID dosing for 14 days versus placebo. The study is designed to assess safety and tolerability and will also include various clinical and laboratory measures and patient reported outcomes (PROs) using the FDA COVID-19 Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Assessment tool.
"This study of emricasan in symptomatic COVID-19 patients marks a significant milestone for Histogen and our partner Amerimmune as we enter the fight against this unprecedented pandemic," said Richard W. Pascoe, President and Chief Executive Officer of Histogen. "Moreover, we believe emricasan is potentially an ideal candidate to treat symptomatic patients in the acute phase, as well as addressing the long-term complications in later phases of COVID-19, due to its anti-inflammatory properties."
"Our first treatment in this clinical trial is an important step toward potentially bringing new and promising treatments to patients with mild COVID-19. SUNY is honored to be involved in this effort to address this medical need," said Raavi Gupta, M.D. Associate Professor and the Principal Investigator at SUNY Downstate Health Sciences University.
"In early 2020, at the beginning of the pandemic, Amerimmune carried out a pioneering study showing that caspases are over-stimulated in the cells of patients with COVID-19, during both acute, late and chronic phases of the disease, potentially resulting in uncontrolled inflammation," said Oral Alpan, M.D., President and CEO of Amerimmune. "Amerimmune will support the Phase 1 study of emricasan in mild COVID-19 patients by carefully evaluating biomarkers of antibody, T cell and caspase related immunity in patients receiving the pan-caspase inhibitor."