SAN FRANCISCO and CINCINNATI, Sept. 1, 2020 /PRNewswire/ -- Aerpio
Pharmaceuticals, Inc. ("Aerpio") (Nasdaq: ARPO) and Quantum
Leap Healthcare Collaborative™ (Quantum Leap) announced today
dosing of the first patient with razuprotafib in the I-SPY COVID
Trial (NCT04488081), a phase 2 platform trial aimed at
improving treatment of acute respiratory distress syndrome
(ARDS) in severely ill COVID-19 (adult) patients. Further details
about the study can be found here.
"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
Laura Esserman , the founder of the
I-SPY programs. "Our group is focused on screening promising agents
and quickly identifying therapies that work. Razuprotafib was
selected because of its potential to reverse the lung damage by
activating Tie2 and stabilizing the leaky blood vessels that cause
some of the damage. This has the potential to prevent death and
improve time to recovery, which is what we need for this pandemic
and any other that comes along in the future."
"We are extremely pleased by the rapid progress in study site
selection and patient screening in this trial," said Joseph Gardner, President and Founder. "We
believe that razuprotafib has the potential to benefit critically
ill COVID-19 patients, and hope to provide additional updates on
progress before the end of the year."
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 Aerpio Pharmaceuticals
Aerpio Pharmaceuticals,
Inc. is a biopharmaceutical company focused on developing
compounds that activate Tie2 to treat ocular diseases and diabetic
complications, as well as other indications in which the Company
believes that activation of Tie2 may have therapeutic potential,
including acute respiratory distress syndrome ("ARDS") associated
with COVID-19 infections. Recently published mouse and human
genetic data implicate the Angpt/Tie2 pathway in maintenance of
Schlemm's canal, a critical component of the conventional outflow
tract. The Company's lead compound, razuprotafib (formerly
AKB-9778), a first-in-class small molecule inhibitor of vascular
endothelial protein tyrosine phosphatase ("VE-PTP"), is being
developed as a potential treatment for open angle glaucoma, and the
Company intends to investigate the therapeutic potential of
razuprotafib in other indications.. The Company is also evaluating
development options for ARP-1536, a humanized monoclonal antibody,
for its therapeutic potential in the treatment of diabetic vascular
complications including nephropathy and diabetic macular edema
("DME"). The Company's third asset is a bispecific antibody that
binds both VEGF and VE-PTP which is designed to inhibit VEGF
activation and activate Tie2. This bispecific antibody has the
potential to be an improved treatment for wet age-related macular
degeneration and DME via intravitreal injection. Finally, the
Company has exclusively out-licensed AKB-4924 (now called GB004), a
first-in-class small molecule inhibitor of hypoxia-inducible
factor-1 (HIF). GB004 is being developed by AKB-4924's exclusive
licensor, Gossamer Bio, Inc. (Nasdaq: GOSS). For more information,
please visit www.aerpio.com.
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 Karyn DiGiorgio
karyn.digiorgio@quantumleaphealth.org.
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
Gossamer Bio for GB004, including the continued development of
GB004 and the milestone and royalty payments related to the
collaboration. Actual results could differ from those projected in
any forward-looking statements due to several risk factors. Such
factors include, among others, the continued development of GB004
and maintaining and deriving the intended benefits of the Company's
collaboration with Gossamer Bio; ability to continue to develop
razuprotafib or other product candidates, including in indications
related to COVID-19; the inherent uncertainties associated with the
drug development process, including uncertainties in regulatory
interactions, the design of planned or future clinical trials,
commencing clinical trials and enrollment of patients in clinical
trials; obtaining any necessary regulatory clearances in order to
commence and conduct planned or future clinical trials; the impact
of the ongoing COVID-19 pandemic on the Company's business
operations, including research and development efforts and the
ability of the Company to commence, conduct and complete its
planned clinical activities; and competition in the industry in
which the Company operates and overall market conditions; and the
additional factors set forth in our Annual Report on Form 10-K for
the year ended December 31, 2019, as updated by our subsequent
Quarterly Reports on Form 10-Q and our other subsequent filings
with the SEC.
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