Aerpio Pharmaceuticals and Quantum Leap Healthcare Collaborative? announced an agreement has been reached to evaluate razuprotafib in a new randomized, investigational treatment arm in the I-SPY COVID Trial for the treatment of acute respiratory distress syndrome (ARDS) in adult patients with moderate to severe COVID-19.

Approximately 10-15% of those infected with the highly contagious SARS-CoV2 virus, the cause of COVID-19, develop ARDS with a death rate in the 2-10% range. Nearly 70% of COVID-19 patients admitted to the ICU require ventilation for a mean of 14 days, and over 50% will not survive. The unprecedented rate of SARS-CoV-2 (COVID-19) infection, over 5.6 million world-wide, has already led to more than 350,000 deaths.

The goal of the I-SPY COVID Trial is to rapidly screen multiple promising agents, in the setting of an adaptive platform trial, for the treatment of critically ill COVID-19 patients to identify agents that will have a high impact on reducing mortality, and the need for as well as duration of, mechanical ventilation.

Preclinical models, large human observational studies, and human genetic studies from leading groups worldwide have independently arrived at the concept that a vascular endothelial receptor, Tie2, may play a pivotal role in the defense against microvascular breach in acute respiratory distress syndrome (ARDS) 1-4. We hypothesize that razuprotafib, being developed as a first-in-class Tie2 activating compound, will exhibit an acceptable safety profile and show efficacy for the treatment of COVID-19 associated ARDS as a potentially life-saving therapeutic for patients suffering from the devasting respiratory effects of COVID-19.

This study arm will evaluate razuprotafib's potential to sufficiently stabilize the pulmonary vasculature, in order to slow or prevent the progression of COVID-19 associated pulmonary pathology, decrease the need for ventilator support, and reduce mortality.

"The I-SPY COVID Trial is designed to rapidly identify and test agents with the potential to provide substantial benefit to patients suffering with acute respiratory distress syndrome (ARDS) from COVID-19, a condition where effective agents are lacking.  We are delighted that Aerpio has agreed to participate in this trial with their agent razuprotafib, as we look forward to evaluating its potential to improve care for this group of patients," said James Palazzolo, CEO of Quantum Leap Healthcare Collaborative.

"We are very pleased to have razuprotafib selected for inclusion in the I-SPY clinical trial.  It will allow us to evaluate the drug in severely ill COVID-19 patients and quickly assess both preliminary safety and efficacy and guide future development plans.  If successfully developed, approved and commercialized, razuprotafib has the potential to help save lives and render the disease less life threatening in the patients most at risk," Joseph Gardner, PhD, Aerpio's President and Founder, said.

As part of the collaboration, Aerpio will supply the investigational drug and provide financial and regulatory support.  The Quantum Leap/ I-SPY team, as sponsor, will provide the clinical sites and clinical expertise.  Aerpio has already produced subcutaneous razuprotafib to support the rapid start-up of this arm of the trial.

The I-SPY COVID Trial (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And molecular analysis) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the U.S. Food and Drug Administration (FDA), industry, patient advocates, philanthropic donors, and clinicians from multiple major U.S. research centers.