Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical
company focused on developing novel therapeutic antibodies for the
treatment of migraine, today announced that it will present new
Phase 3 data for eptinezumab, Alder's lead investigational product
candidate for migraine prevention, at the 70th Annual American
Academy of Neurology Meeting (AAN) in Los Angeles being held April
21-27, 2018.
Eptinezumab will be the subject of eight scientific
presentations. These will include new data from Alder’s PROMISE 1
Phase 3 clinical trial in episodic migraine patients following the
third and fourth quarterly infusions (i.e., 12-month data) and
improvement in patients’ quality of life measures following a
single quarterly infusion. Data from the Company’s PROMISE 2 Phase
3 clinical trial in chronic migraine patients has also been
selected for one of AAN’s two plenary presentation sessions on
Emerging Science clinical trials.
“We are excited to present data from our PROMISE 1 and PROMISE 2
clinical studies at AAN, which further support eptinezumab’s
differentiated clinical profile and its rapid, effective and
sustained migraine prevention benefits,” said Roger K. Cady, M.D.,
Alder’s Vice President of Neurology. “There is a high unmet need
for new treatment options to treat the millions of patients that
continue to struggle with the burden of migraine. Eptinezumab’s
consistent and predictable results across both trials support its
potential to be a meaningful treatment option for the most severely
impacted of these patients and Alder’s goal to advance the
treatment paradigm for migraine prevention.”
Eptinezumab is an investigational monoclonal antibody targeting
calcitonin gene-related peptide (CGRP) for migraine prevention.
Eptinezumab’s mAb design, combined with delivery via quarterly
infusion, allows for strong and immediate inhibition of CGRP
biology.1 Eptinezumab has been studied in several global,
randomized, double-blind, placebo-controlled studies to assess its
safety and efficacy in migraine prevention.
Oral Presentations:
Clinical Trials Plenary Presentation
Session: Emerging ScienceTuesday, April 24, 2018, 11:00 a.m. –
11:15 a.m. PT, Concourse Hall 152-153
- A Phase 3, Randomized, Double-blind, Placebo-Controlled Study
to Evaluate the Efficacy and Safety of Eptinezumab for the
Preventive Treatment of Chronic Migraine: Results of the PROMISE 2
(PRevention Of Migraine via Intravenous eptinezumab Safety and
Efficacy-2) Trial.
- Presenter: Dr. Richard Lipton, Director of the Montefiore
Headache Center, Albert Einstein College of Medicine
Platform Presentations
Session S20: “Best of” Session: Headache Scientific Tuesday,
April 24, 2018, 8:00 a.m. – 8:08 a.m. PT, Convention Center – 515
B
- Primary Results of PROMISE 1 (Prevention Of Migraine via
Intravenous eptinezumab Safety and Efficacy-1) Trial: a Phase 3,
Randomized, Double-blind, Placebo-Controlled Study to Evaluate the
Efficacy and Safety of Eptinezumab for Prevention of Frequent
Episodic Migraines.
- Presenter: Dr. Stephen Silberstein, Professor of Neurology and
Director of the Jefferson Headache Center at Thomas Jefferson
University
Session
S32: Headache: Therapeutics ScientificWednesday, April 25, 2018,
1:12 p.m. – 1:24 p.m. PT, Convention Center – 402
AB
- Increased Migraine-Free Intervals With Eptinezumab Were
Associated With Improved Health-Related Quality-of-Life Outcomes
Through Week 12: Results From the Phase 3 PROMISE 1 Trial.
- Presenter: Dr. Richard Lipton, Director of the Montefiore
Headache Center, Albert Einstein College of Medicine
Poster Presentations:
Wednesday,
April 25, 2018 - 11:30 a.m. – 7:00 p.m. PT, Convention Center –
West Exhibit Hall
- P4 092: Eptinezumab Achieved Meaningful
Reductions in Migraine Activity Within 24 Hours That Were Sustained
Through Week 12: Results From PROMISE 1 (PRevention Of Migraine via
Intravenous eptinezumab Safety and Efficacy-1) Phase 3 Trial.
- Presenter: Dr. Timothy Smith, Medical Director of Mercy Health
Research, Mercy Medical Group
- P4 108: Repeat Infusions of Eptinezumab
Associated With Greater Migraine Reductions and Longer
Migraine-Free Intervals: Results From the Phase 3 PROMISE 1 Trial.
- Presenter: Dr. Egilius Spierings, Director and Principal
Investigator, MedVadis Research Corporation
- P4 091: Eptinezumab Reduced Migraine
Frequency, Duration, and Pain Intensity Through Week 24: Results
From the Phase 3 PROMISE 1 Trial.
- Presenter: Dr. Peter McAllister, Director of the New England
Center for Neurology and Headache
- P4 470 (Emerging Science): Eptinezumab
Achieved Meaningful Reductions in Migraine Activity As Early As Day
1 and Were Sustained Through Week 12: Results From PROMISE 2
(PRevention Of Migraine via Intravenous eptinezumab Safety and
Efficacy-2) Phase 3 Trial in Chronic Migraine.
- Presenter: Dr. David Kudrow, Director of the California Medical
Clinic for Headache
- P4 471 (Emerging Science): Eptinezumab Reduced
Migraine Frequency and Triptan/Ergotamine Use Over Weeks 1-12, and
Improved HIT-6 Scores at Months One and Three: Results From the
Phase 3 PROMISE 2 Trial in Chronic Migraine.
- Presenter: Dr. Stephen Silberstein, Professor of Neurology and
Director of the Jefferson Headache Center at Thomas Jefferson
University
About MigraineMigraine affects 36 million
Americans2 and, worldwide, is considered the sixth-leading cause of
days with disability3 and the third-leading cause of disability of
people under the age of 50.4 The occurrence of migraine can be
unpredictable with a profound impact on activities of daily living.
This disease can last decades, often during what should be the most
productive years of patients’ lives.2 Migraine can remit or
progress to chronic migraine over time and persist as chronic
migraine for years or decades, but it commonly oscillates between
periods of frequent episodic and chronic migraine. Current
preventive treatments for migraine fail to meet the needs of most
patients and most patients discontinue use within 6 months to 1
year due to lack of efficacy and/or side effects.5,6 There is a
significant need for new, effective, and well-tolerated treatment
options.
About Alder BioPharmaceuticals, Inc.Alder
BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical
company committed to transforming the treatment paradigm for
patients with migraine and other serious neurological or
inflammatory conditions. Leveraging its pioneering monoclonal
antibody technologies, Alder discovers and develops novel
therapeutic antibodies designed to deliver highly differentiated,
best-in-class clinical profiles. Alder's lead pivotal-stage product
candidate, eptinezumab, is being evaluated as potentially the
first-to-market migraine prevention infusion therapy. Eptinezumab
is a monoclonal antibody (mAb) inhibiting calcitonin gene-related
peptide (CGRP), which is believed to play a key role in mediating
and initiating 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; the unmet need
for treatment options; the belief that eptinezumab has the
potential to be a meaningful treatment option; and Alder’s goal to
advance the treatment paradigm for migraine prevention. Words such
as “will,” “support,” “need,” “potential,” “option,” “goal,” 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 Alder's development and
commercialization activities; 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 Annual Report on Form 10-K for the fiscal
year ended December 31, 2017, which was filed with the Securities
and Exchange Commission (SEC) on February 26, 2018,, 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.
References
- Baker B, Schaeffler B, Cady R, et al; Rational design of a
monoclonal antibody (mAb) inhibiting calcitonin gene-related
peptide, ALD403 (eptinezumab), intended for the prevention of
migraine. Poster presented at the American Academy of Neurology
(AAN) 2017 Annual Meeting.
- Lipton RB, Silberstein SD. Episodic and chronic migraine
headache: breaking down barriers to optimal treatment and
prevention. Headache. 2015; 55(S2):103-122.
- Migraine Research Foundation. Migraine Facts.
https://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed April 16, 2018.
- Steiner, TJ, Stovner, LJ, & Vos, T. GBD 2015: Migraine is
the third cause of disability in under 50s. The Journal of Headache
and Pain, 2016;17(1).
- Bigal ME, Krymchantowski AV, Lipton RB. Barriers to
satisfactory migraine outcomes. What have we learned, where do we
Stand? Headache. 2009;49(7):1028—1041.
- Hepp, Z, Dodick DW, Varon SF, et al. Adherence to oral
migraine-preventive medications among patients with chronic
migraine. Cephalalgia 2015;35(6):477-88.
Investor
Relations
Contact:
Ashwin
Agarwal
Vice President, Corporate
Strategy
Alder Biopharmaceuticals, Inc.425-408-8567aagarwal@alderbio.com
Michael SchaffzinStern Investor Relations,
Inc.212-362-1200michael@sternir.com
Media
Contact:
Andy Brimmer / Aura Reinhard / Trevor GibbonsJoele Frank, Wilkinson
Brimmer Katcher212-355-4449
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