Full Results from PhaseBio Phase 1 Clinical Trial of PB2452 Published in the New England Journal of Medicine and Presented at...
March 17 2019 - 3:00PM
PB2452 achieved immediate and sustained reversal
of ticagrelor antiplatelet effects
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a
clinical-stage biopharmaceutical company focused on the development
and commercialization of novel therapies for orphan diseases, today
announced that results from the Phase 1 clinical trial of PB2452, a
novel reversal agent for the antiplatelet drug ticagrelor,
demonstrated that PB2452 provided immediate and sustained reversal
of ticagrelor antiplatelet effects without report of drug-related
serious adverse events. The results were published online today in
the New England Journal of Medicine (NEJM) in a paper titled, “An
Antibody-Based Ticagrelor Reversal Agent in Normal Volunteers” and
were presented by Deepak Bhatt, M.D., M.P.H., executive director of
Interventional Cardiovascular Programs at Brigham and Women’s
Hospital and professor at Harvard Medical School, in a featured
clinical research session at the American College of Cardiology’s
68th Annual Scientific Session (ACC.19) in New Orleans.
“Patients taking ticagrelor to reduce the risk
of a cardiac event are currently without an effective method to
reverse its antiplatelet effects, which increases the risk of
spontaneous major bleeding and can quickly produce life-threatening
bleeding should they require emergency surgery,” said Dr. Bhatt.
“The results from the Phase 1 trial demonstrate that intravenous
PB2452 provided immediate and sustained reversal of ticagrelor
antiplatelet activity, thereby potentially reducing the bleeding
risk associated with ticagrelor. The data support further
evaluation of PB2452 for the reversal of the antiplatelet effects
of ticagrelor in emergency situations involving major bleeding and
to enable emergent or urgent surgery in patients.”
The first-in-human, randomized, double-blind,
placebo-controlled Phase 1 clinical trial evaluated the safety,
efficacy and pharmacokinetics of intravenous PB2452 as a ticagrelor
reversal agent in healthy volunteers. Sixty-four volunteers aged 18
to 50 years received either PB2452 or placebo. Ten sequential
cohorts evaluated doses of PB2452 ranging from 0.1 to 18 grams (g)
of PB2452. Cohorts one to three assessed doses of 0.1, 0.3 and 1.0
g of PB2452 infused for 30 minutes in the absence of ticagrelor
pretreatment to assess initial safety. Cohorts four to six received
30-minute infusions of 1.0, 3.0 and 9.0 g of PB2452 or placebo
following ticagrelor pretreatment for 48 hours. Cohorts seven to
ten received an 18 g fixed dose of PB2452 or placebo through
various infusion regimens. PB2452 demonstrated dose-linear
increases in mean exposure across the dose range. Platelet function
was assessed using light transmission aggregometry, a point-of-care
P2Y12 platelet-reactivity test, and vasodilator stimulated
phosphoprotein (VASP) assays.
The results demonstrated that PB2452 reversed
the antiplatelet effects of ticagrelor without report of any
drug-related serious adverse events, dose-limiting toxicities or
infusion-related reactions. The most frequently reported
treatment-emergent adverse event was infusion site bruising (8.3
percent). There were no adverse events leading to study drug
discontinuation or hospitalization.
“We are encouraged by the clinically meaningful
results from the Phase 1 trial, which demonstrate the potential of
PB2452 to provide immediate and sustained reversal of ticagrelor
antiplatelet activity,” said John Lee, M.D., Ph.D., Chief Medical
Officer of PhaseBio. “Furthermore, PB2452 exhibited a very
favorable safety profile in healthy volunteers. Today’s oral
presentation at ACC.19 and simultaneous publication in the New
England Journal of Medicine highlight the strength of the data and
the potential for PB2452 to address significant unmet medical need.
We look forward to initiating a Phase 2a trial of PB2452 in the
first half of this year and continuing to evaluate PB2452 as the
first reversal agent for ticagrelor.”
The abstract is available on the Publications
page of the PhaseBio website: www.phasebio.com.
About PB2452
PB2452 is a novel, recombinant, human monoclonal
antibody antigen-binding fragment, or Fab fragment, designed to
reverse the antiplatelet activity of ticagrelor in major bleeding
and urgent surgery situations. In Phase 1 clinical and preclinical
studies, PB2452 achieved immediate and complete reversal of
ticagrelor’s antiplatelet activity, which has the potential to
bring life-saving therapeutic benefit by increasing the safety of
ticagrelor and mitigating concerns regarding the bleeding risk
associated with antiplatelet drugs. There are currently no approved
reversal agents for ticagrelor or any other antiplatelet drugs.
About PhaseBio
PhaseBio Pharmaceuticals, Inc. is a
clinical-stage biopharmaceutical company focused on the development
and commercialization of novel therapies to treat orphan diseases,
with an initial focus on cardiopulmonary disorders. The company’s
lead development candidate is PB2452, a novel reversal agent for
the antiplatelet therapy ticagrelor. PhaseBio is also leveraging
its proprietary elastin-like polypeptide (“ELP”) technology
platform to develop therapies with the potential for less-frequent
dosing and improved pharmacokinetics. PhaseBio’s second product
candidate PB1046, which is based on ELP, is a once-weekly
vasoactive intestinal peptide receptor agonist for the treatment of
pulmonary arterial hypertension.
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,” “anticipates,” and “future” or similar
expressions are intended to identify forward-looking
statements.
Forward-looking statements include statements concerning our
clinical trials and our research, development and regulatory plans
for PB2452, PB1046 and our ELP research programs. 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, 2018. 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:Annie Starr6 Degrees(973)
415-8838astarr@6degreespr.com
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