Pharmacodynamics Evaluation of PhaseBio’s Novel Ticagrelor Reversal Agent Presented at ESC Congress 2019
September 03 2019 - 8:00AM
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 data from an evaluation of the pharmacodynamics of
PB2452, a novel reversal agent for the antiplatelet drug
ticagrelor, were presented by Lisa K. Jennings, Ph.D., Professor of
Medicine, University of Tennessee Health Science Center, at ESC
Congress 2019 in Paris on September 1.
“Utilizing multiple assays of platelet function
provided a wider range of understanding of the pharmacodynamics of
PB2452 in the first-in-human clinical trial,” said Dr. Jennings.
“PB2452 provided immediate and sustained reversal of ticagrelor
antiplatelet activity, which could reduce the bleeding risk
associated with ticagrelor. The Phase 1 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 64 healthy volunteers aged 18 to 50 years.
Platelet function was assessed using light transmission
aggregometry, VerifyNow PRUTest and vasodilator stimulated
phosphoprotein (VASP) assays. VerifyNow PRUTest is considered to be
the gold standard for point-of-care assessments of platelet
function. The data demonstrated that complete reversal by all
measurements occurred within 15 minutes of administration and was
sustained for over 20 hours.
PhaseBio has continued to use the same three
assays to demonstrate the efficacy of PB2452 in a Phase 2a trial
and has continued to see a high degree of correlation among the
assays in both trials.
“These primary measures of efficacy in our
clinical trials are a key feature of the Accelerated Approval
program that will help streamline the defined regulatory path for
PB2452, coupled with its Breakthrough Therapy designation,” said
John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio. “The U.S.
Food and Drug Administration recently acknowledged that there is a
clear unmet need for reversal of bleeding events related to P2Y12
inhibitors, including ticagrelor. As we move PB2452 into Phase 2b
development by year’s end and initiate our Phase 3 trial in the
first quarter of 2020, we believe that we are well-positioned to
execute on our strategy to deliver this potentially life-saving
therapy to patients in need.”
Additional information including the abstract
can be found on the ESC Congress website here.
About PB2452
PB2452 is a novel, recombinant, human monoclonal
antibody antigen-binding fragment, or Fab, designed to reverse the
antiplatelet activity of ticagrelor in major bleeding and urgent
surgery situations. In a Phase 1 clinical trial, PB2452
demonstrated the potential to bring life-saving therapeutic benefit
through immediate and sustained reversal of ticagrelor’s
antiplatelet activity, mitigating concerns regarding bleeding risks
associated with the use of antiplatelet drugs. The Phase 1 clinical
trial of PB2452 in healthy volunteers was published in the New
England Journal of Medicine in March 2019.1 In April
2019, PB2452 received Breakthrough Therapy designation from
the U.S. Food and Drug Administration (“FDA”).
Breakthrough Designation may be granted by FDA when
preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over existing therapy. In the
first quarter of 2020, PhaseBio plans to initiate a single pivotal
Phase 3 clinical trial of PB2452 which will support a Biologics
License Application for both major bleeding and surgery
indications. 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.
Investor Contact:John SharpPhaseBio
Pharmaceuticals, Inc. Chief Financial Officer(610)
981-6506john.sharp@phasebio.com
Media Contact: Gina Cestari 6 Degrees (917)
797-7904 gcestari@6degreespr.com
1 Bhatt DL, Pollack CV, Weitz JI, et al. Antibody-Based
Ticagrelor Reversal Agent in Healthy Volunteers. N Engl J
Med 2019;Mar 17.
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