Results previously presented in a Late-Breaking
Science Session at the American Heart Association’s 2021 Scientific
Sessions
Global Phase 3 trial of bentracimab achieved
both primary reversal endpoint and co-primary endpoint of clinical
hemostasis
Bentracimab had no drug-related serious adverse
events
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiopulmonary diseases,
today announced the publication of the interim results from
REVERSE-IT (Rapid and
SustainEd ReVERSal of TicagrElor – Intervention Trial) in the New England Journal of Medicine
Evidence, a new digital journal from the NEJM (New England Journal
of Medicine) Group. REVERSE-IT is PhaseBio’s ongoing pivotal Phase
3 trial of its lead product bentracimab, which is designed to study
the reversal of the antiplatelet effects of ticagrelor in patients
who present either (i) with a need for urgent surgery or an
invasive procedure or (ii) who are experiencing uncontrolled major
or life-threatening bleeding.
The results of the prespecified interim analysis were previously
presented on November 15, 2021, by Deepak L. Bhatt, M.D., M.P.H.,
Executive Director of Interventional Cardiovascular Programs at
Brigham and Women’s Hospital and professor at Harvard Medical
School, during a Late-Breaking Science Session at the 2021 American
Heart Association Scientific Sessions.
“We are pleased to see the publication of these highly positive
interim Phase 3 results in a leading peer-reviewed scientific
publication like NEJM Evidence,” said John Lee, M.D., Ph.D., Chief
Medical Officer of PhaseBio. “This first analysis of bentracimab in
patients demonstrated a remarkable safety profile with no
drug-related serious adverse events reported and a low thrombotic
event rate. Importantly, the highly significant clinical efficacy
demonstrated in the surgical patients suggests strongly that we
will see similar efficacy in bleeding patients upon completion of
the study. Both urgent surgery and major, uncontrolled bleeding
represent clear unmet needs for patients on ticagrelor worldwide
who lack an effective reversal agent. We remain on track to submit
our planned Biologics License Application (BLA) to the U.S. Food
and Drug Administration (FDA) in mid-2022 and intend to seek
approval for both urgent surgery and major bleeding
indications.”
REVERSE-IT Clinical Program
The REVERSE-IT trial is expected to enroll approximately 200
major bleeding or urgent surgery patients at sites in the United
States, Canada, the European Union and China. Based on prior
guidance from the FDA, to balance the two patient populations, the
REVERSE-IT trial does not allow enrollment of more than
approximately two-thirds of either the uncontrolled major or
life-threatening bleeding population or urgent surgery or invasive
procedure population. Because the total number of patients enrolled
in the prespecified interim analysis included 142 patients who
required urgent surgery or an invasive procedure, PhaseBio has
determined that the surgery cohort of the trial has been fully
enrolled. With the successful completion of enrollment in this
surgery cohort, REVERSE-IT trial sites have shifted focus to
enrolling patients with uncontrolled major or life-threatening
bleeding events. PhaseBio is seeking to accelerate enrollment of
patients with uncontrolled major or life-threatening bleeding,
including by working to increase the number of enrolling clinical
trial sites as it believes that a broader site footprint will
increase the probability of enrolling these patients.
The FDA also previously indicated that an interim analysis of
the first approximately 100 patients enrolled in the REVERSE-IT
trial would be sufficient to support the submission of a BLA for
accelerated approval of bentracimab. The FDA recommended that the
100 patients comprising the interim analysis include approximately
50 patients from each of the major or life-threatening bleeding
population and urgent surgery or invasive procedure population,
although the FDA noted that whether there are an adequate number of
patients from either cohort would be a review issue and considered
in the context of other data submitted with the BLA. PhaseBio is
commencing preparation of the BLA and is targeting a BLA submission
to the FDA in mid-2022.
Bentracimab has been studied in Phase 1 and Phase 2 clinical
trials and demonstrated immediate and sustained reversal of the
antiplatelet activity of ticagrelor. If these data are reproduced
in the final results from the Phase 3 study, bentracimab may have
the potential to bring life-saving therapeutic benefit to patients
by potentially mitigating concerns regarding bleeding risks
associated with the use of ticagrelor. 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 and elderly
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 and elderly 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.
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/20211201006179/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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