PhaseBio Announces Case Study Highlighting PB1046 Hemodynamic Data Presented at the 14th Pulmonary Vascular Research Institut...
February 04 2020 - 4:01PM
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiopulmonary diseases,
today announced presentation of data from a patient who received
more than 18 months of treatment with PB1046, the company’s
first-in-class, sustained-release vasoactive intestinal peptide
(VIP) analogue being evaluated for the treatment of patients with
pulmonary arterial hypertension (PAH). The data, which were
presented at the 14th Pulmonary Vascular Research Institute (PVRI)
World Congress held in Lima, Peru, from January 30th through
February 2nd 2020, demonstrate clinically-meaningful improvements
in all of the hemodynamic parameters assessed, which were sustained
for up to three months after the last dose was administered.
The patient was part of PhaseBio’s Phase 1b/2a
pilot study which evaluated the multi-dose safety, pharmacokinetics
(PK) and VIP-based pharmacodynamic effects of PB1046 in three PAH
patients who have a permanently implanted hemodynamic monitor
(CardioMEMS™ HF System), a device placed in the pulmonary artery
(PA) which continuously measures heart rate along with systolic and
diastolic pressures. PB1046 was administered subcutaneously on
a weekly basis for eight weeks at dose levels previously tested and
observed to have a favorable safety profile. All three patients
completed the eight-week study with no drug-related serious adverse
events and PB1046 appeared to be well tolerated with only mild
injection site erythema. In one patient, the subject of the case
study, treatment was extended for a total of 18 months, based on
continued improvements in hemodynamic parameters. The CardioMEMS
monitoring system detected reductions in mean PA pressure and total
pulmonary resistance and increases in stroke volume and cardiac
output without an increase in heart rate with PB1046.
“We were pleased to see sustained positive
long-term effects in an adult patient with PAH who had been treated
with PB1046,” said Raymond Benza, MD, cardiologist at the Allegheny
Health Network in Pittsburgh, Pennsylvania. “We believe these data
validate the continued evaluation of PB1046 in the ongoing Phase 2b
clinical trial and underscore its potential to be a once-weekly
treatment for PAH, a progressive and life-threatening orphan
disease with no known cure.”
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. In addition to VIP-mediated
vasodilation, PB1046 may suppress the adverse remodeling of blood
vessels and increase cardiac contractility and relaxation. 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 to date.
The U.S. Food and Drug Administration has
granted PB1046 orphan drug designation for the treatment of PAH
(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: 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 PB6440, an oral
agent for the treatment of resistant hypertension. PhaseBio’s
proprietary 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 clinical trials
and our research, development and regulatory plans for PB1046
and the potential for PB1046 to be disease-modifying.
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 September 30, 2019. 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.
Investor Contact:John SharpPhaseBio
Pharmaceuticals, Inc. Chief Financial Officer(610)
981-6506john.sharp@phasebio.com
Media Contact:Gina Cestari6 Degrees(917)
797-7904gcestari@6degreespr.com
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