Aerpio Pharmaceuticals has partnered with Quantum Leap Healthcare Collaborative to assess razuprotafib in the I-SPY COVID trial to treat acute respiratory distress syndrome (ARDS) in adults with moderate to severe Covid-19.
Razuprotafib is designed to attach to and block vascular endothelial protein tyrosine phosphatase (VE-PTP), a key negative regulator of Tie2. Reduced Tie2 activity is known to cause vascular instability in various diseases, including diabetes.
In preclinical tests, razuprotafib’s activation of Tie2 was observed to stabilise vasculature, which may be beneficial in various disease states, including Covid-19-related ARDS.
The I-SPY COVID Trial was designed to assess experimental Covid-19 therapies and determine the most effective treatments for specific patient subgroups depending on molecular characteristics.
It is being conducted by a consortium that includes the US Food and Drug Administration (FDA ), industry, patient advocates, philanthropic donors, and clinicians across several research centres.
Under the terms of the partnership, Quantum Leap Healthcare Collaborative sponsors the trial and manages all study operations.
Razuprotafib will be assessed in a new randomised, investigational treatment arm of the study, which will evaluate the drug’s ability to sufficiently stabilise the pulmonary vasculature.
The aim is to slow or prevent the progression of Covid-19-related pulmonary pathology, reduce the need for ventilator support, and decrease mortality.
Quantum Leap Healthcare Collaborative CEO James Palazzolo said: “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.”
As part of the alliance, Aerpio will supply the drug and provide financial and regulatory support while the Quantum Leap/ I-SPY team will provide the clinical sites and clinical expertise.