Treatment options for ARDS are limited beyond mechanical ventilation, and approximately 40 percent of ARDS patients do not survive.īIO-11006 is a novel peptide that inhibits the pro-inflammatory effects of overactive MARCKS protein. Breathing becomes difficult and oxygen cannot get into the body. ARDS is a life-threatening condition causing widespread capillary leakage and inflammation of the lungs. ARDS can be caused by a variety of insults including bacterial and viral pneumonia, sepsis, smoke inhalation, aspiration, and, most recently, the novel COVID-19 virus. In the US, until recently, approximately 200,000 patients were stricken annually with ARDS. Globally, acute respiratory distress syndrome affects over 3 million people a year. For more information please visit: : Identifier ( NCT03202394)
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Key secondary endpoints included change in the SpO2/Fi02 ratio, time free of mechanical ventilation, and time in the ICU. The primary endpoint was safety determined by the frequency of adverse events including all-cause mortality at 28 days. This was a 38 patient placebo-controlled randomized clinical study evaluating BIO-11006 or placebo in patients who developed ARDS and who received mechanical ventilation as standard of care. In ARDS, the method of action of BIO-11006 has been shown to inhibit the influx of neutrophils into the lung and the resultant cytokine storm that characterizes the acute illness. The COVID-19 pandemic has forced the medical community to address the urgent need for better emergency respiratory treatments and ARDS is a co-morbid factor in patients hospitalized with the virus. Faster improvement in oxygenation measures supported the decrease in mortality. Clinical results with BIO-11006 demonstrated a 43 percent reduction in all-cause mortality at 28 days. The study evaluated the safety and efficacy of aerosolized BIO-11006 Inhalation Solution in patients with moderate to severe ARDS due to sepsis where all patients received mechanical ventilation as standard of care. The University of North Carolina was the lead site and data monitoring center.
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The Phase 2a placebo-controlled trial ( NCT03202394) was conducted on 38 patients enrolled at four clinical sites.
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,” stated Brian Dickson, MD, Chief Executive Officer of Biomarck Pharmaceuticals. “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. Carson, MD, Professor of Medicine at the University of North Carolina School of Medicine and the Marsico Lung Institute and Principal Investigator on the study. Observed improvements in some of the clinical outcomes are very encouraging, and set the stage for a larger trial,” said Shannon S. “The novel compound appeared to be safe and well tolerated in these very ill patients. The 38-patient study met the primary endpoint of no significant increase in serious adverse events, and reduced all-cause mortality from ARDS at 28 days. DURHAM, N.C.-( BUSINESS WIRE)- Biomarck Pharmaceuticals, Ltd., a biopharmaceutical company developing targeted anti-MARCKS technology for the treatment of ARDS, cancer and other difficult to treat diseases, today announced results of a Phase 2a clinical study for patients with ARDS.
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