US-based Biomarck Pharmaceuticals has dosed the first patient in its Phase II clinical trial of investigational drug BIO-11006 for the treatment of acute respiratory distress syndrome (ARDS).

BIO-11006 is a peptide being developed to target and inhibit the MARCKS protein, which could trigger cell division and movement upon phosphorylation.

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The placebo-controlled, randomised Phase II trial will assess the safety and efficacy of BIO-11006 in ARDS patients who are under mechanical ventilation as a standard of care.

Biomarck Pharmaceuticals CEO Dr Brian Dickson said: “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.

“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.”

“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.”

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The Phase II trial will evaluate all-cause mortality at 30 days as its primary endpoints, while the secondary endpoints are PaO2/Fi02 ratio, time on ventilator and sequelae.

In addition to the respiratory disease, BIO-11006 has an active investigational new drug application for oncology indications, including non-small cell lung cancer (NSCLC).

During preclinical studies, BIO-11006 monotherapy is reported to have demonstrated efficacy in inhibiting metastases and decreasing tumour size in cases with NSCLC.