PhaseBio recently received formal written
minutes from the FDA following its Pre-BLA Meeting held in early
April and is expecting to submit its Biologics License Application
(BLA) by early in the fourth quarter of 2022
The FDA indicated willingness to accept a BLA
with data from 25-30 uncontrolled bleeding patients, in addition to
surgical patients enrolled to date, to potentially support a label
that includes both surgical and uncontrolled bleeding
indications
To date, PhaseBio has enrolled 35 uncontrolled
bleeding patients and has completed enrolling surgical patients in
the Phase 3 REVERSE-IT trial
Conference call and webcast today at 8:30 a.m.
ET
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 completion of a successful Type B pre-biologics
license application (pre-BLA) meeting with the U.S. Food and Drug
Administration (FDA) for bentracimab, a 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. Based on this pre-BLA
meeting and the formal written minutes received from the FDA,
PhaseBio intends to submit the BLA for bentracimab by early in the
fourth quarter of 2022.
During the pre-BLA meeting, the FDA agreed that the company’s
plans to submit a BLA with data from 25-30 patients with
uncontrolled bleeding, together with data from the fully completed
surgical cohort, appeared reasonable to support a label with both
bleeding and surgical indications but would be a review issue based
on the data submitted. To date, and subject to final adjudication,
the REVERSE-IT trial has enrolled 35 patients taking ticagrelor who
experienced uncontrolled bleeding events. PhaseBio previously
intended to base its BLA submission on data from the interim
analysis of the Phase 3 REVERSE-IT trial published in December
2021, and the recently presented Phase 2b trial data. Based on the feedback received from the FDA
during the pre-BLA meeting, PhaseBio will include in the BLA
submission the additional bleeding patients who have enrolled in
the REVERSE-IT trial since the pre-specified interim analysis was
completed to support a potential bleeding indication.
"This meeting with the FDA marks a significant step forward for
the bentracimab development program and PhaseBio," said Jonathan
Mow, Chief Executive Officer of PhaseBio Pharmaceuticals. "This is
an important moment in the development of bentracimab and a
testament to the patients and the commitment and perseverance of
the physicians and employees who have worked so diligently on the
development of this potentially life-saving medicine. We are
rapidly moving ahead with our BLA submission and our pre-commercial
and manufacturing efforts to ensure that, if approved, bentracimab
will be widely available to patients and caregivers.”
John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio
Pharmaceuticals, stated, "We believe the data from our pivotal
clinical trials, including the interim analysis of the Phase 3
REVERSE-IT trial, will show that bentracimab can deliver immediate
and sustained restoration of platelet function in patients taking
ticagrelor who require surgery or experience an uncontrolled
bleeding event. We are confident that we have a robust data package
for this regulatory submission, and we look forward to continuing
to work collaboratively with the FDA to advance the bentracimab BLA
submission toward its review as soon as possible."
In addition to discussing the potential allowance of additional
bleeding patients into the BLA submission, the FDA also noted that,
if during the review process the application was deemed adequate to
support approval for only one of the two requested indications, the
agency would consider separating and allowing for possible
Accelerated Approval of only one of the two indications.
For post-marketing requirements, the FDA confirmed its prior
recommendation that the company complete enrollment in the Phase 3
REVERSE-IT trial and submit data from a total of at least 200
patients from this trial, and establish a post-approval registry
study that will be active ahead of a product launch following
potential Accelerated Approval. PhaseBio plans to continue to
enroll patients for the bleeding population to complete the
post-approval requirement of completing the REVERSE-IT trial.
Bentracimab has been studied in completed 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 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 early in the fourth
quarter of 2022.
Today’s Conference Call Information
PhaseBio will host a conference call and webcast today at 8:30
a.m. ET to discuss the Pre-BLA meeting. Analysts and investors can
participate in the conference call by dialing (866) 221-1776 for
domestic callers and (270) 215-9926 for international callers,
using the conference ID 7190686. The webcast can be accessed live
on the Events and Presentations page in the Investors section of
the PhaseBio website, www.phasebio.com. The webcast will be
archived on the company’s website for 90 days and will be available
for telephonic replay for 14 days following the call by dialing
(855) 859-2056 (Domestic) or (404) 537-3406 (International),
conference ID 7190686.
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, with complete results announced and presented in
April 2022. 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, including
enrollment, 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, EMA 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, and our ability to complete post-approval requirements.
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, 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/20220516005342/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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