PhaseBio Announces Completion of Phase 2a Clinical Trial of PB2452 for the Reversal of the Antiplatelet Activity of Ticagrelo...
September 24 2019 - 4:01PM
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiopulmonary orphan
diseases, today announced the completion of its Phase 2a clinical
trial of PB2452. Full data from the trial are planned to be
presented at an upcoming medical congress.
In the trial, PB2452 achieved immediate and
sustained reversal of ticagrelor in older (ages 50-64) and elderly
(ages 65-80) subjects on dual antiplatelet therapy of ticagrelor
and low-dose aspirin. PB2452 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. The older and
elderly subjects in the Phase 2a trial resemble the patient
population most likely to be treated with ticagrelor and to
potentially benefit from PB2452, if approved.
Based on guidance provided by the U.S. Food and
Drug Administration (“FDA”) during the PB2452 End-of-Phase 1
meeting in July of this year, the Phase 2a trial also investigated
a PB2452 regimen for the reversal of supratherapeutic doses of
ticagrelor in healthy younger subjects. In the
supratherapeutic-dose cohort, PB2452 demonstrated immediate and
sustained reversal of ticagrelor and was well tolerated, consistent
with the earlier cohorts in the Phase 2a and Phase 1 trials.
Statistically significant reversal of the antiplatelet activity of
supratherapeutic blood levels of ticagrelor was achieved within 5
minutes of initiation of PB2452 infusion and sustained for 24
hours. Platelet function was normalized by 30 minutes following
initiation of PB2452 infusion and remained normal for 24 hours.
Based on the preliminary results from this cohort, PhaseBio
believes that it has identified an appropriate PB2452 regimen for
use in patients who may have supratherapeutic blood levels of
ticagrelor as a result of ticagrelor drug-drug interactions or
overdosage.
“With the successful completion of our Phase 1
and 2a studies, we are excited to be moving forward into our
registrational studies for PB2452,” said John Lee, M.D., Ph.D.,
Chief Medical Officer of PhaseBio. “Our defined regulatory path for
PB2452 remains on track as we prepare to advance the program into a
Phase 2b trial in the fourth quarter of this year and a pivotal
Phase 3 trial in the first quarter of 2020. We continue to be
encouraged about the potential of PB2452 to address a significant
unmet need for patients by reversing the antiplatelet activity of
ticagrelor in major bleeding and urgent surgery situations.”
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, 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 published in the New
England Journal of Medicine in March 2019.1 In April 2019, PB2452
received Breakthrough Therapy designation from the FDA.
Breakthrough Designation may be granted by FDA when preliminary
clinical evidence indicates that the drug may demonstrate
substantial improvement over existing therapy. PhaseBio plans to
initiate a single pivotal Phase 3 clinical trial of PB2452 in the
first quarter of 2020 to support a Biologics License Application
for PB2452 in both major bleeding and surgery indications. 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 June 30,
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
_______________________________________
- 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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