PhaseBio receives clearance of IND application
from U.S. FDA under Coronavirus Treatment Acceleration Program
(CTAP)
“VANGARD” trial will assess the efficacy and
safety of PB1046 in hospitalized COVID-19 patients at high risk for
rapid clinical deterioration and acute respiratory distress
syndrome
Based on FDA feedback, PhaseBio believes that
positive, clearly interpretable and clinically meaningful trial
results may enable PhaseBio to submit a Biologics License
Application
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiopulmonary diseases,
today announced FDA authorization to proceed with VANGARD, a
potentially pivotal clinical trial to evaluate PB1046 as a
treatment for hospitalized COVID-19 patients who are at high risk
for rapid clinical deterioration and acute respiratory distress
syndrome (ARDS).
PB1046 is a novel, once-weekly, subcutaneously-injected
vasoactive intestinal peptide (VIP) receptor agonist that targets
VPAC receptors in the cardiovascular, pulmonary and immune systems.
VIP is a neurohormone known to have anti-inflammatory,
antifibrotic, inotropic, lusitropic and vasodilatory effects and
several cardiopulmonary disorders are associated with alterations
in levels of VIP or its receptors, VPAC1 and VPAC2. Importantly,
VIP has also been observed to have potent bronchodilatory and
immunomodulatory effects in the respiratory system. Specifically,
VIP has been shown to regulate proinflammatory cytokines including
TNF-α, IFN-γ, IL-12, IL-17A and IL-6. In animal models, treatment
with VIP peptide prevented acute lung injury and inhibited
cytokine-mediated inflammatory responses that are characteristic of
ARDS.
“Based on the mechanism of action, the well-documented clinical
profile of PB1046, a once-weekly-dosing regimen that eliminates the
need for continuous IV infusions required to administer VIP
peptide, and evidence of activity of VIP peptide in ARDS, we
decided to pursue a rigorous, double-blind randomized trial to
evaluate PB1046 as a treatment for COVID-19 patients at high risk
of progressing to acute respiratory distress syndrome,” said
Jonathan Mow, Chief Executive Officer at PhaseBio. “PhaseBio moved
very rapidly to develop a study protocol and submit an
investigational new drug application (IND) to the FDA. I would like
to thank the team at PhaseBio, our network of advisors and
investigators and the FDA for the collaborative effort to launch
this trial in such an expedited manner.”
The VANGARD trial (VIP ANalogue, in hospitalized COVID-19 patients at
hiGh risk for rapid clinical
deterioration and ARDS) is a
multi-center, randomized, double-blind, parallel group clinical
trial that will assess the efficacy and safety of once-weekly
subcutaneous injections of PB1046 in hospitalized COVID-19 patients
at high risk for rapid clinical deterioration and ARDS.
Approximately 210 patients will be targeted to be enrolled at
approximately 20 sites nationwide. The primary endpoint will
measure days alive and free of respiratory failure.
Having received FDA clearance to initiate the VANGARD trial,
PhaseBio expects to begin dosing patients by the end of June.
Subject to the pace of enrollment and any further impacts from the
COVID-19 pandemic, PhaseBio is targeting to report trial results
late in the fourth quarter of 2020. Based on feedback from the FDA,
PhaseBio believes that positive, clearly interpretable and
clinically meaningful results from this trial may enable PhaseBio
to submit a Biologics License Application.
“Physicians are in desperate need of new options to treat
COVID-19 patients facing rapid deterioration of lung function and
before progressing to a ventilator,” said John Lee, M.D., Ph.D.,
Chief Medical Officer at PhaseBio. “The impact of the pandemic on
the global healthcare system has been overwhelming during the past
few months and the importance of new treatment options that could
help reduce this burden cannot be overstated. Based on what we’ve
learned thus far about COVID-19 and acute respiratory distress
syndrome, the prognosis for patients who ultimately require
ventilator support is exceptionally poor. Early mitigation by
PB1046 of the effects of inflammatory cytokines that can cause
acute lung injury, is a promising strategy that could prevent
patients from declining to the point where they require mechanical
ventilation and help alleviate the strain on critical care
infrastructure that we’re witnessing.”
About PB1046
PB1046, a novel, subcutaneously-injected vasoactive intestinal
peptide (VIP) analogue, is a recombinant fusion protein composed of
VIP and PhaseBio’s proprietary elastin-like polypeptide (ELP)
biopolymer. Based on the pharmacokinetic profile of PB1046 observed
in clinical trials, the fusion of VIP to ELP results in both a
prolonged absorption profile and a longer circulating half-life,
enabling once-weekly dosing.
PB1046 is in Phase 2 development for the treatment of pulmonary
arterial hypertension (PAH) and in a Phase 2 clinical trial for the
treatment of hospitalized COVID-19 patients at high risk for rapid
clinical deterioration and acute respiratory distress syndrome,
which the Company refers to as the VANGARD trial. PhaseBio expects
to report initial data from the VANGARD trial in the fourth quarter
of 2020, while results from the Phase 2b trial in PAH are expected
to be reported in 2021. To date, PB1046 has been administered to
more than 70 patients with hypertension or a history of
cardiovascular disease in three Phase 1/2 clinical trials conducted
in the U.S., with no drug-related serious adverse events reported
to date. The U.S. Food and Drug Administration has granted PB1046
orphan drug designation for the treatment of pulmonary arterial
hypertension (WHO Group 1 Pulmonary Hypertension) and
cardiomyopathy associated with dystrophinopathies.
About PhaseBio
PhaseBio Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiopulmonary diseases.
The company’s pipeline includes: bentracimab (PB2452), a novel
reversal agent for the antiplatelet therapy ticagrelor; PB1046, a
once-weekly vasoactive intestinal peptide receptor agonist for the
treatment of pulmonary arterial hypertension and acute respiratory
distress syndrome; and PB6440, an oral agent for the treatment of
resistant hypertension. PhaseBio’s proprietary elastin-like
polypeptide (ELP) technology platform enables the development of
therapies with potential for less-frequent dosing and improved
pharmacokinetics, including PB1046, and drives both internal and
partnership drug-development opportunities.
PhaseBio is located in Malvern, PA, and San Diego, CA. For more
information, please visit www.phasebio.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “anticipates,” “believes,” “expects,”
“intends,” “projects,” and “future” or similar expressions are
intended to identify forward-looking statements. Forward-looking
statements include statements concerning or implying the conduct or
timing of our VANGARD trial of PB1046 for the treatment of COVID-19
patients at high risk for rapid clinical deterioration and ARDS, or
other product candidates in our pipeline, our research, development
and regulatory plans for our product candidates, the potential for
these product candidates to receive regulatory approval from the
FDA or equivalent foreign regulatory agencies, including whether
the FDA will accept the results of VANGARD for submission of a
Biologics License Application, and whether, if approved, these
product candidates will be successfully distributed and marketed.
Forward-looking statements are based on management's current
expectations and are subject to various risks and uncertainties
that could cause actual results to differ materially and adversely
from those expressed or implied by such forward-looking statements.
Accordingly, these forward-looking statements do not constitute
guarantees of future performance, and you are cautioned not to
place undue reliance on these forward-looking statements. Risks
regarding our business are described in detail in our Securities
and Exchange Commission filings, including in our Quarterly Report
on Form 10-Q for the quarter ended March 31, 2020. Such risks may
be amplified by the impacts of the COVID-19 pandemic. These
forward-looking statements speak only as of the date hereof, and
PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update
these statements except as may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20200527005882/en/
Investor Contact: John Sharp PhaseBio Pharmaceuticals,
Inc. Chief Financial Officer (610) 981-6506
john.sharp@phasebio.com
Media Contact: Will Zasadny Canale Communications, Inc.
(619) 961-8848 will@canalecomm.com
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