Alder BioPharmaceuticals Initiates PROMISE 2 Pivotal Trial of Eptinezumab for the Prevention of Migraine
November 28 2016 - 8:00AM
Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a clinical-stage
biopharmaceutical company developing monoclonal antibody
therapeutics, today announced the initiation of PROMISE 2
(
PRevention
Of
Migraine via
Intravenous ALD403
Safety and
Efficacy 2), the
second pivotal Phase 3 clinical trial of eptinezumab (formerly
known as ALD403), its monoclonal antibody candidate inhibiting
calcitonin gene-related peptide (CGRP), for the prevention of
migraine. Alder also announced today that eptinezumab was selected
as the International Nonproprietary Name for ALD403.
“With the initiation of this second pivotal Phase 3 trial, we
are continuing to execute on our plan to advance eptinezumab toward
a planned BLA submission in 2018,” stated Randall C. Schatzman,
Ph.D., President and Chief Executive Officer of Alder. “Through our
development plan, including upcoming top-line data from PROMISE 1
during the first half of 2017, we expect to differentiate
eptinezumab as a unique and best-in-class therapeutic option for
physicians in the treatment of their patients living with
migraine.”
Key Points for PROMISE 2 and Eptinezumab Pivotal Clinical Trial
Program:
- The PROMISE 2 pivotal study will evaluate the safety and
efficacy of eptinezumab in patients with chronic migraine.
- The double-blind, randomized, placebo-controlled trial will
evaluate two dose levels of eptinezumab administered by infusion
once every 12 weeks in approximately 1,050 individuals with chronic
migraine.
- The primary endpoint of the trial is the mean reduction in
migraine days from baseline over weeks 1 to 12.
- Key secondary endpoints are the 75% responder rate over weeks 1
to 12 as determined by the change in migraine days between
eptinezumab and placebo, and the 75% responder rate over weeks 1 to
4 as determined by the change in migraine days between eptinezumab
and placebo.
- Top-line data from PROMISE 2 is expected in the first half of
2018.
- In addition to PROMISE 2, the eptinezumab pivotal trial program
consists of PROMISE 1 (PRevention
Of Migraine via
Intravenous ALD403 Safety and
Efficacy 1), Alder’s ongoing pivotal study
evaluating eptinezumab in approximately 800 patients with frequent
episodic migraine, and a planned open-label study. The open-label
study is intended to confirm the long-term safety and tolerability
of eptinezumab, as required by the U.S. Food and Drug
Administration (FDA). This study is expected to begin in the first
quarter of 2017 and will enroll approximately 120 patients that
will receive eptinezumab administered by infusion every 12 weeks
for one year.
- The results of PROMISE 1, PROMISE 2 and the open-label study
will support a Biologics License Application (BLA) submission to
the FDA for the infusion formulation of eptinezumab.
Eptinezumab is the International Nonproprietary Name (INN) and
official generic name given to the Alder drug candidate formerly
known as ALD403 being developed for the prevention of migraine. The
INN system is coordinated by the World Health Organization and is
intended to make communication more precise by providing a unique
standard name for each active ingredient.
About Alder BioPharmaceuticals,
Inc.
Alder BioPharmaceuticals, Inc., is a
clinical-stage biopharmaceutical company that discovers, develops
and seeks to commercialize genetically engineered therapeutic
antibodies with the potential to meaningfully transform current
treatment paradigms. Alder's lead pivotal-stage product candidate,
eptinezumab, is being evaluated for migraine prevention.
Eptinezumab is a monoclonal antibody that inhibits calcitonin
gene-related peptide (CGRP), a protein that is active in mediating
the initiation of migraine. Alder is additionally evaluating
ALD1910, a preclinical product candidate also in development as a
migraine prevention therapy. ALD1910 is a monoclonal antibody that
inhibits pituitary adenylate cyclase-activating polypeptide-38
(PACAP-38), another protein that is active in mediating the
initiation of migraine. Clazakizumab, Alder's third program, is a
monoclonal antibody candidate that inhibits interleukin-6 and is
licensed to Vitaeris, Inc. For more information, please visit
http://www.alderbio.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements relating to: the
continued development and clinical, therapeutic and commercial
potential of eptinezumab; the availability of results from clinical
trials; the initiation and enrollment of future clinical trials;
future regulatory filings and potential regulatory approval of
eptinezumab. Words such as “continuing,” “execute,”
“advance,” “planned,” “upcoming,” “expect,” “will,” “intended,”
"support," "potential," or other similar expressions,
identify forward-looking statements, but the absence of these words
does not necessarily mean that a statement is not forward-looking.
In addition, any statements that refer to expectations, projections
or other characterizations of future events or circumstances are
forward-looking statements. The forward-looking statements in this
press release are based upon Alder's current plans, assumptions,
beliefs, expectations, estimates and projections, and involve
substantial risks and uncertainties. Actual results and the
timing of events could differ materially from those anticipated in
the forward-looking statements due to these risks and uncertainties
as well as other factors, which include, without limitation: risks
related to the potential failure of eptinezumab to demonstrate
safety and efficacy in clinical testing; Alder's ability to conduct
clinical trials and studies of eptinezumab sufficient to achieve a
positive completion; the availability of data at the expected
times; the clinical, therapeutic and commercial value of
eptinezumab; risks and uncertainties related to regulatory
application, review and approval processes and Alder's compliance
with applicable legal and regulatory requirements; risks and
uncertainties relating to the manufacture of eptinezumab; Alder’s
ability to obtain and protect intellectual property rights, and
operate without infringing on the intellectual property rights of
others; the uncertain timing and level of expenses associated with
the development of eptinezumab; the sufficiency of Alder's capital
and other resources; market competition; changes in economic and
business conditions; and other factors discussed under the caption
"Risk Factors" in Alder's Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2016, which was filed with the
Securities and Exchange Commission (SEC) on October 27, 2016, and
is available on the SEC's website at www.sec.gov. Additional
information will also be set forth in Alder's other reports and
filings it will make with the SEC from time to time. The
forward-looking statements made in this press release speak only as
of the date of this press release. Alder expressly disclaims
any duty, obligation or undertaking to release publicly any updates
or revisions to any forward-looking statements contained herein to
reflect any change in Alder's expectations with regard thereto or
any change in events, conditions or circumstances on which any such
statements are based.
Media Contacts:
David Schull or Todd Davenport, Ph.D.
Russo Partners, LLC
(212) 845-4271
(212) 845-4235
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
Investor Relations Contact:
David Walsey
Alder Biopharmaceuticals
(425) 408-8032
ir@alderbio.com
Alder BioPharmaceuticals (NASDAQ:ALDR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Alder BioPharmaceuticals (NASDAQ:ALDR)
Historical Stock Chart
From Apr 2023 to Apr 2024