Alder BioPharmaceuticals Presents Positive Phase 2b Study Data for Eptinezumab at 69th Annual American Academy of Neurology M...
April 28 2017 - 1:24PM
- Eptinezumab emerging clinical profile
suggests migraine preventative benefit achieved as soon as 24 to 48
hours after a single infusion -
Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a
clinical-stage biopharmaceutical company developing monoclonal
antibody therapeutics, today announced the presentation of positive
data from its Phase 2b clinical trial evaluating eptinezumab
(formerly ALD403) for the prevention of migraine.
Key findings from the study showed that chronic migraine
patients treated with a single infusion of eptinezumab (ALD403)
experienced a significant reduction in migraine days as measured by
75% responder rates, with maximum efficacy in 1 to 4 weeks that was
maintained through 12-weeks. Post hoc analysis of the trial data
also suggested that a single administration led to a clinically
meaningful reduction in the percentage of patients experiencing
migraine within 24 to 48 hours post infusion. These data and
additional study results are the topic of a podium presentation
titled “Randomized, Double-Blind, Placebo-Controlled Trial of
ALD403 (Eptinezumab), an Anti-CGRP Peptide Antibody, in the
Prevention of Chronic Migraine” presented at the 69th Annual
American Academy of Neurology (AAN) meeting in Boston.
“Eptinezumab has demonstrated its potential as a preventative
treatment for migraine in clinical trials to date. The data from
these trials, and the fact that it’s the only anti-CGRP monoclonal
antibody being developed for administration via infusion, suggest
that, if approved, eptinezumab may be an important therapeutic
option for patients needing fast onset to migraine prevention that
is sustained for 12 weeks for the treatment of their migraines,”
said Jeffrey Smith, M.D., FRCP, a founder of Alder and managing
director of Alder’s Irish subsidiary, Alder BioPharmaceuticals
Limited.
Randall C. Schatzman, Ph.D., president and chief executive
officer of Alder, added, "These new data further demonstrate the
differentiated delivery and clinical profile of eptinezumab for
migraine prevention. We are on track to report top-line results
from our first Phase 3 pivotal trial of eptinezumab later this
quarter. Our focus is on moving through the clinical development
program toward a BLA filing next year so that eptinezumab, if
approved, can meet patient needs as a potentially transformative
migraine prevention therapy.”
The study was a parallel group, double-blind, randomized,
placebo controlled, dose-ranging Phase 2b trial to evaluate the
efficacy, safety and pharmacokinetics of eptinezumab (ALD403)
administered intravenously in patients with chronic migraine. The
study enrolled 616 patients across 90 sites, stratified into four
experimental dose groups: 10 mg ALD403, 30mg ALD403, 100 mg ALD403,
300 mg ALD403, and a placebo group. The primary endpoint was the
reduction in migraine days as measured by the 75% responder rates
from baseline to week 12, and secondary endpoints included the
evaluation of safety and pharmacokinetics.
Key Points:
A single administration of eptinezumab
(ALD403):
- Significantly reduced migraine days in patients with chronic
migraine as measured by 75% responder rates
- Produced a reduction in the number of patients experiencing
migraine within 24 to 48 hours post infusion*
- Resulted in 1/3 of patients achieving a 75% reduction in their
migraine days in Weeks 1-4 that was maintained through Week 12
- Significantly reduced the percentage of migraine attacks that
patients reported as severe
- Demonstrated a tolerability and safety profile similar to
placebo, with no serious adverse events deemed treatment related or
infusion reactions observed
*post hoc analysis
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: Alder’s belief that
eptinezumab is a unique and potentially transformative migraine
prevention therapy; the continued development and clinical,
therapeutic and commercial potential of eptinezumab (formerly
ALD403); the availability of results from clinical trials; the
potential regulatory approval of eptinezumab; the emerging
differentiated delivery and clinical profile of eptinezumab; and
the high unmet need for preventative migraine treatments.
Words such as “emerging,” “potential,” “suggest,” “may,” “option,”
“on track,” “focus,” “toward,” “can,” “meet,” 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 Inc.
(425) 408-8032
ir@alderbio.com
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