Results of Biomarck Phase II Study of BIO-11006 in Patients with ARDS to be Presented at the 2021 ATS Annual Meeting
NEWTOWN, Pa.--(BUSINESS WIRE)--#ARDS--Biomarck Pharmaceuticals, Ltd., a clinical-stage biopharmaceutical company focused on developing peptides that inhibit MARCKS to treat patients with inflammatory diseases, today announced that data from a Phase II placebo-controlled clinical study of BIO-11006, the Company’s lead peptide, will be presented during the 2021 ATS (American Thoracic Society) Annual Meeting, May 14 – 19, 2021.
The study enrolled 38 patients across four sites at University of North Carolina, University of Pennsylvania, Vanderbilt University and Wake Forest University. Safety of BIO-11006 was confirmed when administered at a dose of 125 mg BID for up to 28 days. Rapid and faster improvements in oxygenation were observed in patients receiving BIO-11006 compared to placebo (half normal saline), together with decreases in pro-inflammatory cytokines. At 28 days there were 7 deaths (37%) in the placebo arm and 4 deaths (21%) in the BIO-11006 treatment arm.
Dr Shannon Carson, MD, Division Chief of Pulmonary Diseases and Critical Care Medicine and Professor of Medicine at University of North Carolina Department of Medicine, and Principal Investigator in the study, commented, “Since patients with moderate and severe ARDS have no approved treatment options beyond mechanical ventilation and other supportive measures, these data are encouraging. It is hoped that these results can now be repeated in a larger clinical trial that includes other important clinical outcomes such as mortality.”
The abstract is available on the conference website and Biomarck will post the presentation to Biomarck’s website under the Publications, Presentations section at www.biomarck.com.
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.
Graham G. Lumsden, CEO