DURHAM, N.C., Biomarck Pharmaceuticals, Ltd today announced that the first patients have been treated with BIO-11006 in a Phase 2 clinical study for patients with Acute Respiratory Distress Syndrome (ARDS). This trial will evaluate the safety and efficacy of Biomarck's novel, patented, MARCKS protein inhibitor in a placebo controlled trial where all patients receive mechanical ventilation as standard of care.
"Currently there are no approved treatments for ARDS other than mechanical ventilation in an ICU and even then up to 40% of patients die within 30 days. As this disease occurs in approximately 200,000 patients per year in the US, the potential to save lives is very clear. Animal studies have shown the ability of BIO-11006 to prevent the disease in the two most predictive models of ARDS and have shown the unique capability to reverse established ARDS. The initiation of this clinical study represents a significant milestone for Biomarck as we progress to clinically develop our patented portfolio in diseases, including non small cell lung cancer (NSCLC) that cause significant morbidity and mortality," said Dr Brian Dickson, Biomarck's Chief Executive Officer.
About the Phase 2 study
This is a placebo controlled randomized clinical study evaluating BIO-11006 or placebo in patients who develop ARDS and are receiving mechanical ventilation as standard of care. The primary endpoint is all cause mortality at 30 days with key secondary endpoints of PaO2/Fi02 ratio, time on ventilator and sequelae. For more information please visit https://clinicaltrials.gov ID number 03202395
BIO-11006 is a novel patented peptide that inhibits the MARCKS protein. Phosphorylation of the MARCKS protein has been shown to stimulate cell division and movement. In the case of ARDS this refers to the prevention of excessive neutrophil movement causing the "cytokine storm." BIO-11006 is part of a portfolio of over 100 patented compounds owned by Biomarck.
Biomarck Pharmaceuticals is a Durham, N.C. based biopharmaceutical company focused on the clinical development of its lead and back up compounds for the treatment of significant disease states such as ARDS and NSCLC. For additional information on Biomarck, please visit the Company's website.
Forward Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Company's plans and expectations for BIO-11006, contain predictions, estimates and other forward looking statements. These forward looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments and the risk related to the efficacy or safety of the Company's development pipeline, the results of further research and development, the high degree of risk and uncertainty associated with drug development, clinical trials and regulatory approval processes, other market or economic factors and competitive and technological advances; and other risks.
Mike Enright, Chief Financial Officer 1-844-424-6627