PhaseBio Announces Positive Preliminary Results from Phase 2a Clinical Trial of PB2452 for the Reversal of the Antiplatelet A...
June 17 2019 - 4:01PM
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for orphan diseases, today
announced preliminary data from its Phase 2a clinical trial of
PB2452, which is the first trial of PB2452 to include older (ages
50-64) and elderly (ages 65-80) subjects on dual antiplatelet
therapy of ticagrelor and low-dose aspirin. Subjects in the trial
resemble the patient population most likely to be treated with
ticagrelor and potentially benefit from PB2452, if approved. In the
trial, statistically significant reversal of ticagrelor was
achieved within 5 minutes of initiation of PB2452 infusion and
sustained for over 20 hours. Platelet function was normalized by 15
minutes following initiation of PB2452 infusion and remained normal
for over 20 hours. To date, PB2452 has been generally well
tolerated in the Phase 2a trial, with only minor adverse events
reported. These new data are consistent with results from
PhaseBio’s previously published Phase 1 trial conducted in healthy
younger volunteers treated with ticagrelor alone and not aspirin.
Efficacy of PB2452 in the Phase 2a trial is measured using the same
three assays that were utilized in the Phase 1 trial, with results
from all three assays showing a high degree of correlation in both
trials.
“For patients taking antiplatelet therapies such
as ticagrelor, it is currently recommended that they stop their
antiplatelet regimen for at least five days prior to undergoing
surgery to reduce the risk of major bleeding,” said John Lee, M.D.,
Ph.D., Chief Medical Officer of PhaseBio. “This isn’t an option for
patients requiring urgent or emergency surgery. For patients
experiencing major bleeding, there are currently no proven methods
to reverse the effects of antiplatelet agents. If approved, PB2452
could help address these critical unmet medical needs by enhancing
the safety profile of ticagrelor, which has the potential to become
the only antiplatelet therapy on the market with a specific
reversal agent. We look forward to reporting full results from the
Phase 2a trial at an upcoming medical congress.”
Additional information on the trial can be found
on www.ClinicalTrials.gov using the identifier
NCT03928353.
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 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 selected as a
late-breaking, oral presentation at The American College of
Cardiology’s Annual Scientific Session1 and published
simultaneously in the New England Journal of Medicine in March
2019.2 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. 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
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 March
31, 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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https://www.acc.org/latest-in-cardiology/clinical-trials/2019/03/15/21/37/ticagrelor-reversal-agent
- 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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