Recently launched Phase 2 “VANGARD” trial to
assess the efficacy and safety of PB1046 in hospitalized COVID-19
patients at high risk for rapid clinical deterioration and acute
respiratory distress syndrome
PB1046, a long-acting analog of vasoactive
intestinal peptide (VIP), has the potential to modulate several
proinflammatory cytokines that are believed to be key drivers of
the inflammatory response to COVID-19
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiopulmonary diseases,
today announced that it has dosed the first patient in VANGARD, a
potentially pivotal Phase 2 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 VIP receptor agonist that targets VPAC
receptors in the cardiovascular, pulmonary and immune systems. VIP
is a neurohormone known to have anti-inflammatory, antifibrotic and
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.
“Having novel treatment options that could help prevent COVID-19
patients from requiring ventilator support is an important step in
fighting against this global pandemic,” said Dr. Andrew Catanzaro,
an investigator in the VANGARD trial and head of Infectious Disease
Medicine at Adventist Healthcare White Oak Medical Center in Silver
Spring, Maryland. “The inflammatory response to COVID-19 has been
an exceptionally challenging aspect of managing infected patients,
and those who require ventilator support have an especially poor
prognosis. The PB1046 mechanism of action has the potential to
mitigate proinflammatory cytokines thought to be key drivers
causing rapid decline in lung function observed in more severe
COVID-19 cases. Through science, and with partners like PhaseBio,
we hope to discover agents that will be active for the inflammatory
response and this is another important step in this process.”
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 is assessing 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 in the
trial measures days alive and free of respiratory failure.
“We are pleased that the initial patient has been enrolled in
our potentially pivotal Phase 2 trial of PB1046 in hospitalized
COVID-19 patients who are facing rapid deterioration of lung
function,” said Jonathan Mow, Chief Executive Officer, PhaseBio
Pharmaceuticals. “Physicians are in desperate need of new options
to treat COVID-19 patients, and PhaseBio is working to be a key
part of the solution to this global pandemic. To have initiated the
VANGARD trial in the midst of a pandemic that has severely impacted
the global healthcare system in an unprecedented manner is a
testament to the resolve and determination of the PhaseBio team,
trial investigators and our network of advisors. We remain on track
to report trial results late in the fourth quarter of 2020.”
As the COVID-19 pandemic unfolded around the world, PhaseBio
moved rapidly to develop a trial protocol and submit an IND
application to the FDA to evaluate the potential of PB1046 to help
COVID-19 patients at high risk of progressing to ARDS. PhaseBio
received FDA clearance in May to initiate the VANGARD trial and,
subject to the pace of enrollment and any further impacts from the
COVID-19 pandemic itself, the Company is targeting to report
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.
More information about the VANGARD phase 2 trial is available at
ClinicalTrials.gov, using the identifier NCT04433546.
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 ARDS, 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 United States. The FDA 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 hospitalized
COVID-19 patients at high risk for rapid clinical deterioration and
ARDS; and PB6440, an oral agent for the treatment of resistant
hypertension. PhaseBio’s proprietary elastin-like polypeptide
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/20200716006010/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.
will@canalecomm.com 619-961-8848
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