PhaseBio Announces Bentracimab Phase 2b Trial Data Accepted for Late Breaking Clinical Research Presentation at the 2022 American College of Cardiology (ACC.22) Annual Scientific Session
10 Février 2022 - 2:00PM
Business Wire
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 Phase 2b trial of bentracimab, which was
conducted in healthy, older volunteers 50-80 years old, has been
accepted for presentation in a Late Breaking Clinical Research
session at the American College of Cardiology Annual Scientific
Session & Expo being held in Washington, D.C., April 2-4, 2022.
The Phase 2b trial is a multi-center, randomized, double-blind,
placebo-controlled study with 150 subjects receiving bentracimab
and 50 subjects receiving placebo after all were pretreated with
dual antiplatelet therapy composed of ticagrelor and low-dose
aspirin. Top-line results from the Phase 2b trial were previously
announced in November 2021.
Presentation Information
- Title: Bentracimab Immediately and Significantly
Reverses the Antiplatelet Effects of Ticagrelor in Older
People
- Presenting Author: Deepak L. Bhatt, M.D., MPH, Executive
Director of Interventional Cardiovascular Programs, Brigham and
Women's Hospital and Professor of Medicine at Harvard Medical
School
- Session Title: Featured Clinical Research I
- Session Number: 403-10
- Date: April 2, 2022
- Session Time: 12:00 pm – 1:15 pm ET
- Presentation Time: 12:15 pm – 12:25 pm ET
“As part of the pivotal development program for bentracimab,
which also includes the Phase 3 REVERSE-IT trial, the Phase 2b
trial was designed to help answer important safety and efficacy
questions related to bentracimab use in older subjects pre-treated
with ticagrelor and aspirin therapy,” said John Lee, M.D., Ph.D.,
Chief Medical Officer of PhaseBio. “We are pleased to have the
opportunity to present the results from this trial to key
stakeholders in the cardiology community at a high-profile medical
congress like ACC.22.”
REVERSE-IT is a Phase 3, multi-center, open-label, prospective
single-arm trial designed to study reversal of the antiplatelet
effects of ticagrelor with bentracimab in patients who present with
uncontrolled major or life-threatening bleeding or who require
surgery or invasive procedure. Approximately 200 patients are being
targeted to be enrolled from major health centers worldwide. In
November 2021, PhaseBio presented interim results from the
REVERSE-IT trial during a Late-Breaking Science Session at the 2021
American Heart Association Scientific Sessions. In December 2021,
the REVERSE-IT interim results were subsequently published in NEJM
Evidence, a new digital journal from the NEJM (New England Journal
of Medicine) Group. The Company is commencing preparation of the
BLA and targeting a BLA submission to the U.S. Food and Drug
Administration (FDA) in mid-2022.
Bentracimab has been studied in Phase 1 and Phase 2 clinical
trials and has demonstrated the potential to bring life-saving
therapeutic benefit through immediate and sustained reversal of the
antiplatelet activity of ticagrelor, potentially mitigating
concerns regarding bleeding risks associated with the use of this
antiplatelet drug. Additionally, in a translational study,
bentracimab achieved equivalent reversal of branded ticagrelor and
multiple ticagrelor generics.
About Bentracimab (PB2452)
Bentracimab 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, bentracimab 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 this antiplatelet drug. Data from the Phase 1
clinical trial of bentracimab in healthy volunteers was published
in the New England Journal of Medicine in March 2019. In April
2019, bentracimab received Breakthrough Therapy Designation from
the FDA. In September 2019, PhaseBio completed a Phase 2a trial in
which bentracimab was investigated in healthy, older subjects on
dual antiplatelet therapy of ticagrelor and low-dose aspirin.
Additionally, the Phase 2a trial investigated a bentracimab regimen
for the reversal of supratherapeutic doses of ticagrelor in healthy
younger subjects. In November 2021, PhaseBio completed a Phase 2b
trial in which bentracimab was investigated in healthy, older
subjects on dual antiplatelet therapy of ticagrelor and low-dose
aspirin. In all active treatment arms in both the Phase 2a and
Phase 2b trials, bentracimab achieved immediate and sustained
reversal of the antiplatelet effects of ticagrelor and 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. PhaseBio initiated REVERSE-IT, a pivotal
Phase 3 clinical trial of bentracimab, in March 2020 to support a
potential Biologics License Application for bentracimab in both
major bleeding and urgent surgery indications. Interim results from
the Phase 3 REVERSE-IT trial were presented in November 2021 and
subsequently published in NEJM Evidence in December 2021.
About PhaseBio
PhaseBio Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiovascular and
cardiopulmonary diseases. PhaseBio’s pipeline includes: bentracimab
(PB2452), a novel reversal agent for the antiplatelet therapy
ticagrelor; pemziviptadil (PB1046), a once-weekly vasoactive
intestinal peptide (VIP) receptor agonist for the treatment of
pulmonary arterial hypertension; and PB6440, an oral agent for the
treatment of resistant hypertension. PhaseBio’s proprietary
elastin-like polypeptide technology platform enables the
development of therapies with potential for less-frequent dosing
and improved pharmacokinetics, including pemziviptadil, 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, and follow us on
Twitter @PhaseBio and LinkedIn.
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,” “potential,” “projects,” “target,” “will,” “would” 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 our product
candidates, the timing of availability or disclosure of data from
those clinical trials and the timing of planned regulatory
submissions, the potential for these product candidates to receive
regulatory approval from the FDA or equivalent foreign regulatory
agencies, and whether, if approved, these product candidates will
be successfully distributed, marketed and commercialized.
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,
2021. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220210005430/en/
Investor Contact: John Sharp PhaseBio Pharmaceuticals,
Inc. Chief Financial Officer (610) 981-6506
john.sharp@phasebio.com
Media Contact: Will Zasadny Canale Communications, Inc.
(619) 961-8848 will.zasadny@canalecomm.com
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