Results presented on April 2nd during a Late
Breaking Featured Clinical Research Presentation at the American
College of Cardiology’s 71st Annual Scientific Session (ACC.22)
Trial achieved primary reversal endpoint in
older volunteers
Bentracimab was well tolerated in the Phase 2b
trial, with no drug-related serious adverse events or thrombotic
events reported
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiovascular diseases,
today announced the complete results from its Phase 2b clinical
trial of bentracimab that were presented on April 2nd during a Late
Breaking Featured Clinical Research Presentation at the American
College of Cardiology’s 71st Annual Scientific Session (ACC.22).
The Phase 2b trial was a multi-center, randomized, double-blind,
placebo-controlled study, which enrolled a total of 205 older
volunteers (50-80 years old), with 154 subjects receiving
bentracimab and 51 subjects receiving placebo, after all were
pretreated with dual antiplatelet therapy composed of ticagrelor
and low-dose aspirin. The Phase 2b pivotal trial was conducted
concurrently with the company’s ongoing REVERSE-IT Phase 3 pivotal
trial of bentracimab, as agreed upon with the U.S. Food and Drug
Administration (FDA) following an End-of-Phase 1 meeting in July
2019. Bentracimab is a novel, recombinant, human monoclonal
antibody antigen-binding fragment designed to reverse the
antiplatelet activity of ticagrelor in patients presenting with
uncontrolled bleeding or in need of surgery.
The primary efficacy endpoint for the Phase 2b trial was
reversal of ticagrelor’s inhibition of platelet function in
actively treated subjects versus placebo as measured using the
point-of-care VerifyNow® PRUTest® platelet function assay
(VerifyNow). In the Phase 2b trial, bentracimab significantly
restored platelet function within five minutes of administration
(p<0.001), as measured by multiple assays including VerifyNow.
The reversal results were tightly correlated across all assays used
in the study to measure platelet function. VerifyNow is also the
primary measurement used to evaluate efficacy in the ongoing
REVERSE-IT Phase 3 trial.
There were no drug-related serious adverse events or thrombotic
events reported in the Phase 2b trial. Overall, bentracimab
appeared well tolerated, with subjects reporting only non-serious
adverse events. The most-commonly reported adverse events were
injection site bruising and headache, with similar rates seen in
both the placebo and active-treatment arms. There was no
significant difference between bentracimab and placebo for any of
the adverse events reported.
“The positive data from this Phase 2b trial of bentracimab build
on the prior results that have already been published in the New
England Journal of Medicine and NEJM Evidence,” said 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. “Based on these data, and
the other clinical results we have seen to date, bentracimab
appears to be a promising option for ticagrelor reversal once it is
hopefully approved.”
These complete safety and efficacy data from the Phase 2b trial
are consistent with results from PhaseBio’s previously completed
Phase 1 trial, conducted in healthy younger volunteers treated with
ticagrelor alone and not aspirin, and its Phase 2a trial, conducted
in healthy, older (ages 50-80) subjects on dual antiplatelet
therapy of ticagrelor and low-dose aspirin and with topline results
previously announced for the Phase 2b trial on November 3, 2021.
More than 300 subjects have been treated with bentracimab across
the Phase 1, 2, and 3 clinical trials that comprise the bentracimab
development program. Additional information on the Phase 2b trial
can be found on www.ClinicalTrials.gov using the identifier
NCT04122170.
“The Phase 2b trial of bentracimab is a key component of our
pivotal development program and we are pleased with the results
presented by Dr. Bhatt at ACC.22," said John Lee, M.D., Ph.D.,
Chief Medical Officer of PhaseBio. “The trial results provide
support for the safety and efficacy profile of bentracimab, and
also provide key safety data that will be included as part of our
planned Biologics License Application (BLA) submission to the FDA,
which remains on track for 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.
Bentracimab is currently being evaluated in the REVERSE-IT
study, a global 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
urgent surgery or invasive procedure. Approximately 200 patients
are being targeted for enrollment in the REVERSE-IT study at major
health centers worldwide. Patients with reported use of ticagrelor
within the prior three days who require urgent ticagrelor reversal
are eligible for enrollment. A prespecified interim analysis from
the REVERSE-IT trial was presented on Monday, November 15, 2021,
during a late-breaking science session at the American Heart
Association’s Scientific Sessions 2021. The Company is commencing
preparation of a BLA and targeting submission to the FDA in
mid-2022.
About Bentracimab (PB2452)
Bentracimab is a novel, recombinant, human monoclonal antibody
antigen-binding fragment designed to reverse the antiplatelet
activity of ticagrelor in patients who present with uncontrolled
bleeding or require surgery. 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
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 to treat
patients with uncontrolled bleeding or requiring surgery. 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 diseases.
The Company’s pipeline includes: bentracimab (PB2452), a novel
reversal agent for the antiplatelet therapy ticagrelor; 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, 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, CDE or equivalent foreign
regulatory agencies, and whether, if approved, these product
candidates will be successfully distributed, marketed and
commercialized, including having sufficient product supply at
launch. 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 Annual
Report on Form 10-K for the year ended December 31, 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/20220404005386/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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