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SAN FRANCISCO and CINCINNATI,
"Finding an effective therapeutic agent to treat patients who get critically ill in response to the COVID-19 infection is of utmost importance regardless of whether we have a vaccine," said
"We are extremely pleased by the rapid progress in study site selection and patient screening in this trial," said
The I-SPY COVID TRIAL, is an adaptive platform trial sponsored by Quantum Leap Healthcare Collaborative. The goal of the trial is to rapidly screen, in parallel, multiple promising agents in order to identify drugs that will have a high impact on reducing mortality, and avoid or reduce the duration of mechanical ventilation for critically-ill COVID-19 patients. 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.
About the I-SPY TRIALs
The I-SPY 2 TRIAL for stage II and III breast cancer is the longest running and most successful adaptive platform tria in oncologyl. Quantum Leap was able to use the existing I-SPY 2 TRIAL infrastructure methodology to develop the I-SPY COVID Trial (Investigation of Serial studies to Predict Your COVID Therapeutic Response with biomarker Integration and Adaptive Learning). The I-SPY COVID Trial is designed to rapidly screen promising experimental treatments, and re-purpose existing agents to identify the most effective treatments for severely ill COVID-19 patients. 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. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.quantumleaphealth.org, www.ispytrials.org or contact
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 University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients, and researchers. Quantum Leap provides operational, financial, and regulatory oversight to all I-SPY Trials. For more information, visit www.quantumleaphealth.org.
About Razuprotafib (formerly known as 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 and more recently has been shown to contribute to the development of increased IOP and glaucoma. 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. Aerpio is studying a topical ocular formulation of razuprotafib in open angle glaucoma and exploring the utility of subcutaneous razuprotafib for diabetic complications, including diabetic nephropathy. In addition, a subcutaneous formulation of razuprotafib is being explored for its therapeutic potential in treating or preventing ARDS associated with COVID-19.
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 SEC available at www.sec.gov.
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SOURCE Quantum Leap Healthcare Collaborative
Investors & Media: Aerpio Pharmaceuticals, Inc., Joseph Gardner, President & Founder, firstname.lastname@example.org OR Gina Marek, VP Finance, email@example.com OR Investors: Irina Koffler, LifeSci Advisors, firstname.lastname@example.org