PhaseBio Provides Pemziviptadil (PB1046) Program Update
December 21 2021 - 8:00AM
Business Wire
Phase 2b trial of pemziviptadil in pulmonary
arterial hypertension (PAH) voluntarily ended early by the Company
in order to evaluate existing program data and determine next steps
forward
Company to reprioritize resources and capital
towards successful commercialization of bentracimab and advancement
of other pipeline programs
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 the company is voluntarily ending its Phase 2b
trial of pemziviptadil (PB1046) in PAH due to COVID-19 impacts on
manufacturing, associated drug supply and the rate of enrollment in
the study. The company will analyze the trial data to determine an
appropriate path forward for the program, which depending on the
results could include an improved product presentation and
simplified product dosing in a subsequent trial. With the
suspension of the Phase 2b trial, the company will reprioritize
resources and capital towards pre-commercialization activities of
bentracimab and the advancement of other pipeline programs,
including PB6440 for resistant hypertension. The Phase 2b trial of
pemziviptadil, named the VIP trial (Vasoactive
Intestinal Peptide in adult patients with pulmonary
arterial hypertension), had successfully enrolled more than 50% of
the study’s target population.
“With the continued impact of the COVID-19 pandemic on this
Phase 2b clinical trial, we believe a full evaluation of the
program makes sense at this time and that any positive data
generated could help galvanize support for the future development
of pemziviptadil,” said Jonathan Mow, Chief Executive Officer,
PhaseBio Pharmaceuticals. “Upon completion of the final analyses of
the pemziviptadil trial, we will evaluate the potential for a
future trial of pemziviptadil. We continue to believe pemziviptadil
is a potentially valuable asset for the treatment of pulmonary
arterial hypertension and other diseases.”
About Pemziviptadil (PB1046)
Pemziviptadil, a novel, subcutaneously injected 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 pemziviptadil observed in PhaseBio
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.
Pemziviptadil was in Phase 2 development for the treatment of
PAH. To date, pemziviptadil has been administered to more than 100
patients with cardiovascular or cardiopulmonary diseases in five
clinical trials conducted in the United States. The FDA has granted
pemziviptadil orphan drug designation for the treatment of
pulmonary arterial hypertension (WHO Group 1 Pulmonary
Hypertension) and cardiomyopathy associated with Duchenne Muscular
Dystrophy.
About PhaseBio
PhaseBio Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiovascular and
cardiopulmonary diseases. PhaseBio’s pipeline includes: bentracimab
(PB2452), a novel reversal agent for the antiplatelet therapy
ticagrelor; pemziviptadil (PB1046), a once-weekly VIP receptor
agonist for the treatment of pulmonary arterial hypertension; 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
pemziviptadil, 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, and follow us on
Twitter @PhaseBio and LinkedIn.
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2021. 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/20211221005212/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.zasadny@canalecomm.com
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