Benzinga | Aug 16, 2021 08:03AM EDT

Histogen and Amerimmune Announce Additional Findings From Phase 1 Study Of Emricasan In Mild Symptomatic COVID-19 Patients; Says Emricasan Found To Have Statistically Significant Improvements In Clinically Relevant Hematological And Immune Markers

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Emricasan Found to Have Statistically Significant Improvements in Clinically Relevant Hematological and Immune Markers Which May Lead to Potential Clinical Benefits in COVID-19 Patients

SAN DIEGO, Aug. 16, 2021 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ:HSTO) and its partner Amerimmune, LLC today announced additional findings from its Phase 1 study of emricasan in mild symptomatic COVID-19 patients to assess safety, tolerability, and preliminary efficacy. As previously reported, emricasan was shown to be safe and well tolerated during the 14 days of dosing and at the day 45 follow up, as compared to placebo, with no reports of serious adverse events. Patients who completed treatment with emricasan had a complete resolution of the symptoms most commonly associated in mild COVID-19, such as a cough, headache, and fatigue at day 7 and continued through day 45. The p-value was p<0.007. Patients in the placebo arm who completed the study showed either delay or no symptom resolution for the duration of the study.

Further analysis of the laboratory and exploratory biomarkers from the patients in this study shed critical insight into potential mechanisms of COVID-19 and how emricasan blocks this process to prevent disease progression. First, in the emricasan cohort, there was an increase in certain blood immune cell numbers, which play an important role in immunity against viruses. Second, patients that received emricasan showed normalization of several serum markers related to increased risk for blood clotting that are typically elevated in individuals with COVID-19. Third, substances that leak from dying cells in the body decreased and normalized in the emricasan cohort. These findings correlated with trends toward better immunity to SARS CoV2. Collectively, this data points to the role of emricasan in mild COVID19 and cell death as the core problem in COVID-19.

"The study data has provided us with critical information on the mechanism of COVID-19, which we believe will be critical for the planning of the next phase of our clinical development program," said Dr. Oral Alpan, M.D. Chief Executive Officer of Amerimmune LLC.

"These additional findings further reinforce that emricasan can potentially be developed as a therapeutic treatment for mild to moderate COVID-19," said Richard W. Pascoe, Histogen's President and Chief Executive Officer. "We, along with Amerimmune, are currently developing a Phase 2 clinical strategy for emricasan as a new therapeutic option for the treatment of COVID-19 in parallel with exploring partnering opportunities for its future development and commercialization."

About the Emricasan Phase 1 Study

This double blinded, 1:1 randomized, placebo controlled single site study enrolled 13 symptomatic mild-COVID-19 patients in an outpatient setting using emricasan at 25mg BID dosing for 14 days versus placebo with a one-month safety follow up. The study was designed to assess safety and tolerability and 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. A total of 13 patients were enrolled at a single site in New York City versus the initially targeted 40 patients. The decision to stop enrollment with a lesser number of patients was based solely upon the overall decline in COVID-19 cases in New York City and its negative impact on patient recruitment.