PhaseBio Announces First Patient Dosed in Phase 2b Clinical Trial of PB2452 for Reversal of the Antiplatelet Activity of Tica...
October 15 2019 - 8:00AM
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 first patient has been dosed in a Phase 2b
clinical trial of PB2452, a novel, recombinant, human monoclonal
antibody antigen-binding fragment designed to reverse the
antiplatelet activity of ticagrelor in major bleeding and urgent
surgery situations.
The Phase 2b multi-center, randomized,
double-blind, placebo-controlled trial is designed to evaluate the
safety and efficacy of PB2452 in reversing the antiplatelet effects
of ticagrelor as part of a dual antiplatelet regimen including
low-dose aspirin. Additionally, the Phase 2b trial marks the
beginning of United States Food and Drug Administration
(“FDA”)-aligned registrational trials to support the submission of
a Biologics License Application (“BLA”) for potential accelerated
approval of PB2452. Approximately 200 older and elderly (ages
50-80) subjects are expected to be enrolled, resembling the patient
population most likely to be treated with ticagrelor and
potentially benefit from PB2452, if approved. Subjects will be
randomized in a ratio of 3:1 and will receive either PB2452 or
placebo, with approximately 150 subjects receiving PB2452. The
primary endpoint of the trial is reversal of the antiplatelet
effects of ticagrelor with intravenous infusion of PB2452 or
placebo, as measured by the VerifyNow® PRUTest® biomarker.
“We are pleased that the first patient has been
dosed in the registrational Phase 2b clinical trial of PB2452, as
it signifies continued progress on our Accelerated Approval pathway
discussed with the FDA at our End-of-Phase 1 meeting,” said John
Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio. “We continue
to be encouraged by the potential of PB2452 to address a
significant unmet need for patients by reversing the antiplatelet
activity of ticagrelor in major bleeding and urgent surgery
situations. Our plans to initiate our Phase 3 trial in the first
quarter of 2020 and potentially submit a BLA for PB2452 in the
second half of 2022 remain on track.”
PhaseBio recently completed a Phase 2a trial in
which PB2452 achieved immediate and sustained reversal of the
antiplatelet effects of ticagrelor in older and elderly subjects on
dual antiplatelet therapy of ticagrelor and low-dose aspirin.
PB2452 was generally well tolerated, with only minor adverse events
reported. These results are consistent with the results observed in
healthy younger subjects treated with ticagrelor in the previously
published Phase 1 trial. Additionally, the Phase 2a trial
investigated a PB2452 regimen for the reversal of supratherapeutic
doses of ticagrelor in healthy younger subjects, which demonstrated
immediate and sustained reversal of the antiplatelet effects of
ticagrelor and was well tolerated, consistent with the earlier
cohorts in the Phase 2a trial and the Phase 1 trial.
Additional information on the trial can be found
on https://clinicaltrials.gov/ using the identifier
NCT04122170.
About PB2452
PB2452 is a novel, recombinant, human monoclonal
antibody antigen-binding fragment 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 FDA.
Breakthrough Therapy designation may be granted by FDA when
preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over existing therapy. PhaseBio
plans to initiate a single pivotal Phase 3 clinical trial of PB2452
in the first quarter of 2020 to support a Biologics License
Application for PB2452 in both major bleeding and urgent 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.
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, timelines for regulatory submissions 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 June 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
1. Bhatt
DL, Pollack CV, Weitz JI, et al. Antibody-Based Ticagrelor Reversal
Agent in Healthy Volunteers. N Engl J Med 2019; 380:1825-1833
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