Alder to Present Migraine Prevention Data for Eptinezumab at 59th Annual Scientific Meeting of the American Headache Society...
June 07 2017 - 12:00PM
Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), today announced four
data presentations at the 59th Annual Scientific Meeting of the
American Headache Society in Boston from June 8-11, 2017. The
presentations will highlight Phase 2b clinical data and analyses
for eptinezumab (formerly ALD403), Alder’s investigational
monoclonal antibody currently in Phase 3 clinical trials for
migraine prevention.
“Alder is excited to present some of the encouraging eptinezumab
clinical data observed to date, which we believe continues to
support eptinezumab as a potential therapy for migraine prevention,
including meaningful migraine prevention activity within 24 to 48
hours following a single administration,” said Randall C.
Schatzman, Ph.D., president and chief executive officer of Alder.
“We expect to announce top-line results from PROMISE 1, our pivotal
Phase 3 trial evaluating eptinezumab in patients living with
frequent episodic migraine, before the end of the month. We are
focused on moving efficiently through our second Phase 3 pivotal
trial, PROMISE 2, and toward a BLA submission in the second half of
2018.”
Presentation Details:
Oral presentation on Saturday, June 10, 2017 from 8:50 am – 9:00
am ET by Jeffrey T.L. Smith, M.D., FRCP, Senior Vice President,
Translational Medicine at Alder: “Randomized, Double-blind,
Placebo-controlled Trial of ALD403 (eptinezumab), an Anti-CGRP
Monoclonal Antibody for the Prevention of Chronic Migraine”
Poster presentation on Friday, June 9, 2017: “ALD403
(eptinezumab) Elicits Meaningful Reductions in Migraine Activity 24
Hours After a Single Intravenous Administration”
Poster presentation on Friday, June 9, 2017: “Responders to
ALD403 (eptinezumab) Show Significant Reduction in Headache Impact
at Weeks 4 through 12 Following a Single Infusion in Chronic
Migraine”
Poster presentation on Friday, June 9, 2017: “Rational Design of
a Monoclonal Antibody Inhibiting Calcitonin Gene-Related Peptide,
ALD403 (eptinezumab), for the Prevention of Migraine”
About EptinezumabEptinezumab, formerly ALD403,
is Alder’s lead pivotal-stage investigational product candidate in
development as a migraine prevention treatment for patients with
chronic and frequent episodic migraine. Eptinezumab is a novel
monoclonal antibody that inhibits the calcitonin gene-related
peptide, or CGRP, a small protein involved in the transmission of,
and heightened sensitivity to, pain experienced in migraine.
About Alder BioPharmaceuticals 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 StatementsThis
press release contains forward-looking statements, including,
without limitation, statements relating to: the continued
development and clinical, therapeutic and commercial potential of
eptinezumab (formerly ALD403); the availability of results from
clinical trials; and the potential regulatory submission for
eptinezumab. Words such as "will," “support,” "potential,"
"expect," "focused," "toward," 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
year ended March 31, 2017, which was filed with the Securities and
Exchange Commission (SEC) on April 27, 2017, 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
Russo Partners, LLC
(212) 845-4271
david.schull@russopartnersllc.com
Investor Relations Contact:
David Walsey
Alder Biopharmaceuticals
(425) 408-8032
ir@alderbio.com
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