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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 this 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, a 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
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.
Quantum Leap, sponsor of the I-SPY 2 TRIALs which is well-known for its adaptive platform trial in breast cancer, announced plans on
About the I-SPY COVID 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
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative (Quantum Leap) is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at
About Razuprotafib (previously AKB-9778)
Razuprotafib binds to and inhibits vascular endothelial protein tyrosine phosphatase (VE-PTP), an important negative regulator of Tie2. Decreased Tie2 activity contributes to vascular instability in many diseases including diabetes. Razuprotafib activates the Tie2 receptor irrespective of extracellular levels of its binding ligands, angiopoietin-1 (agonist) or angiopoietin-2 (antagonist) and may be the most efficient pharmacologic approach to maintain normal Tie2 activation. As seen preclinically, activation of Tie2 by razuprotafib stabilizes vasculature which may have beneficial effects in a variety of disease states, including ARDS associated with COVID-19 infections.
Forward Looking Statements
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the Company's product candidates, including razuprotafib, ARP-1536 and the bispecific antibody asset, the clinical development plan therefor and the therapeutic potential thereof, the Company's plans and expectations with respect to razuprotafib and the development therefor and therapeutic potential thereof in addressing COVID-19 and the intended benefits from the Company's collaboration with
These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the Company files with the
- Saharinen, P., Eklund, L. & Alitalo, K. Therapeutic targeting of the angiopoietin-TIE pathway. Nat Rev Drug Discov 16, 635-661, doi:10.1038/nrd.2016.278 (2017).
- Parikh, S. M. The Angiopoietin-Tie2 Signaling Axis in Systemic Inflammation. J Am Soc Nephrol 28, 1973-1982, doi:10.1681/ASN.2017010069 (2017).
- Higgins, S. J. et al. Tie2 protects the vasculature against thrombus formation in systemic inflammation. J Clin Invest 128, 1471-1484, doi:10.1172/JCI97488 (2018).
- Leligdowicz, A., Richard-Greenblatt, M., Wright, J., Crowley, V. M. & Kain, K. C. Endothelial Activation: The Ang/Tie Axis in Sepsis. Front Immunol 9, 838, doi:10.3389/fimmu.2018.00838 (2018).
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SOURCE Quantum Leap Healthcare Collaborative
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