Results of Biomarck Clinical and Preclinical Studies of BIO-11006 in ARDS to be Presented at the 2021 ARDS Drug Development Summit

At 28 days there were 7 deaths (37%) in the placebo arm and 4 deaths (21%) in the BIO-11006 treatment arm.

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Wednesday, July 7, 2021
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Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Medical specialties, Branches of biology, Clinical medicine, Intensive care medicine, Immunology, Respiratory diseases, Ards, Acute respiratory distress syndrome, Cytokine storm, Respiratory distress syndrome, Infant respiratory distress syndrome, Neutrophil
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United States, PENNSYLVANIA, NORTH CAROLINA, ARDS
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Summary
Key Points: 
  • At 28 days there were 7 deaths (37%) in the placebo arm and 4 deaths (21%) in the BIO-11006 treatment arm.
  • Treatment with BIO-11006 prevented development of ARDS, reversed established ARDS and prevented neutrophil influx into the lungs.
  • It is hoped that these results can now be repeated in a larger clinical trial currently being planned.
  • Inhibiting MARCKS with our peptides reduces the adverse effects of inflammation, including acute respiratory distress syndrome (ARDS) and cytokine storm.


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 clinical and preclinical studies of BIO-11006, the Company’s lead peptide, will be presented during the 2021 ARDS Drug Development Summit, a virtual event being held July 13 – 15, 2021.

In the Phase 2 clinical study, 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.

BIO-11006 was effective in three preclinical mouse models, lipopolysaccharide (LPS), Strep. pneumoniae and lipoteichoic acid (LTA). Treatment with BIO-11006 prevented development of ARDS, reversed established ARDS and prevented neutrophil influx into the lungs.

Professor Kenneth Adler, PhD, Professor of Cell Biology at North Carolina State University’s College of Veterinary Medicine, and Presenter at the Summit, commented, “Compelling evidence of efficacy has been demonstrated with BIO-11006 in preclinical models and in a Phase 2 study. It is hoped that these results can now be repeated in a larger clinical trial currently being planned.”

The presentation will be available after the summit on the Biomarck website in the Publications section www.biomarck.com/publications.

About 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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