Biomarck Pharmaceuticals said that a Phase 2a clinical trial of its BIO-11006 inhalation solution in patients with acute respiratory distress syndrome (ARDS) met its primary endpoint, with a 43% decrease in mortality at 28 days compared to placebo. According to Biomarck, previous studies have shown that BIO-11006, the 10 amino acid N-terminal of a protein called myristoylated alanine rich c-kinase substrate (MARCKS), has the ability to interfere with processes that can lead to cytokine storm and ARDS.
The study enrolled 38 patients who had moderate to severe ARDS resulting from sepsis. Patients received either BIO-11006 delivered via the Aeroneb Pro nebulizer or placebo in addition to mechanical ventilation. In addition to the reduction in mortality, the study demonstrated improvements in oxygenation and a reduction in time spent in the intensive care unit. There was no significant increase in serious adverse events for patients receiving BIO-11006.
Principal Investigator Shannon S. Carson, Professor of Medicine at the University of North Carolina School of Medicine and the Marsico Lung Institute, commented, “The novel compound appeared to be safe and well tolerated in these very ill patients. Observed improvements in some of the clinical outcomes are very encouraging, and set the stage for a larger trial.”
Biomarck CEO Brian Dickson said, “Based on these data and BIO-11006’s safety and efficacy profile, we intend to move the investigational therapy towards a Phase 3 clinical study. We look forward to continuing our discussions with the FDA as, now more than ever, patients with severe COVID-19 infection are progressing to ARDS with no treatment other than ventilators.”
Read the Biomarck Pharmaceuticals press release.
