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.
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.
“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.”
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.