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, Ltd., is a clinical stage biotechnology company focused on treating patients with inflammatory and immunological diseases, using our platform of patent-protected peptides that have been developed to inhibit MARCKS. As a critical component of the inflammatory process, MARCKS is responsible for neutrophil aggregation at the site of inflammation and cytokine release. Inhibiting MARCKS with our peptides reduces the adverse effects of inflammation, including acute respiratory distress syndrome (ARDS) and cytokine storm. Phase 2 trials have been completed with our lead peptide, BIO-11006, in ARDS, COPD and NSCLC, confirming safety and efficacy in these three potential indications. In vivo data demonstrate that BIO-11006 and other peptides in the Biomarck pipeline inhibit inflammation in dermatology and ophthalmology models. Potential indications include uveitis, dry eye, atopic dermatitis and psoriasis.
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