-- Pivotal PROMISE 1 top-line results
show eptinezumab met primary and key secondary endpoints
--
Alder BioPharmaceuticals, Inc., (NASDAQ:ALDR) today announced that
eptinezumab, its lead product candidate for migraine prevention,
met the primary and key secondary endpoints in PROMISE 1, a Phase 3
pivotal clinical trial evaluating patients with frequent episodic
migraine.
PROMISE 1 Highlights
- PROMISE 1 met the primary endpoint: highly statistically
significant reductions in monthly migraine days;
- Significant Day 1 clinical benefit: ≥50% reduction in the
proportion of patients experiencing a migraine on Day 1
post-dose;
- Significant 75% responses at all key time points: ~1/3 of
patients achieved a ≥75% reduction in migraine days through 4 and
12 weeks;
- Average of 1 in 5 patients had 100% response: no migraines in
any given month, months 1 through 6; and
- The safety profile was similar to placebo: consistent with
previously reported eptinezumab studies.
“Approximately 13 million people suffer from the pain and
debilitation of migraines that occur four or more days a month, yet
nine out of 10 individuals don’t utilize preventive therapy due to
limitations in efficacy, safety and tolerability,” said Roger Cady,
MD, Alder Vice President of Neurology and Fellow of the American
Headache Society. “Patients deserve more from their treatments, and
these data show eptinezumab could be a major advance in meeting the
significant unmet need for patients to regain control of their
lives.”
PROMISE 1 Top-Line ResultsThe primary endpoint, demonstrating
statistically significant reductions in monthly migraine days from
baseline (average of 8.6 days) over weeks 1 through 12 was 4.3
monthly migraine days for 300mg (p=0.0001) and 3.9 days for 100mg
(p=0.0179) compared to an average 3.2 days for placebo. A 30mg dose
level evaluated in the study was not tested as per the statistical
analysis plan.
Secondary endpoints evaluating time points through the first
quarterly dose include:
- ≥75% reduction in monthly migraine days achieved over weeks 1
through 4 of 31.5% for 300mg and (p=0.0066), and 30.8% for 100mg
(p=0.0112) compared to 20.3% for placebo.
- ≥75% reduction in monthly migraine days achieved over weeks 1
through 12 of 29.7% for 300mg (p=0.0007), and 22.2% for 100mg (not
statistically significant) compared to 16.2% for placebo.
- ≥50% reduction in monthly migraine days achieved by 56.3% of
patients over weeks 1 through 12 for 300mg (p=0.0001) and 49.8% for
100mg (p=0.0085, unadjusted) compared to 37.4% for placebo.
- 53.6% reduction in the proportion of patients experiencing
migraine on the day following administration at 300mg (p=0.0087,
unadjusted), and 51.3% at 100mg (p=0.0167, unadjusted), compared to
20.7% for placebo
Secondary endpoints demonstrated responses that were improved
through the second quarterly dose period, and include:
- ≥75% reduction in monthly migraine days achieved over weeks 13
through 24 of 40.1% for 300mg (p=0.0006, unadjusted), and 33.5% for
100mg (p=0.0434, unadjusted) compared to 24.8% for placebo.
- Average of one in five patients receiving 300mg (20.6%) had
100% responses with no migraines in any given month (months 1
through 6).
The observed safety profile in this study to date was similar to
placebo. Both the safety profile and the placebo rates were
consistent with previously reported eptinezumab studies. Full
safety data will be available at the end of the study.
“Alder’s goal is to discover and develop best-in-class therapies
that have the potential to transform the lives of the millions of
underserved patients who are seeking long-term freedom from their
migraines,” said Alder President and Chief Executive Officer Randy
Schatzman, Ph.D. “These positive results, consistent with
previously reported eptinezumab studies, support the unique
clinical profile of eptinezumab as a potential first-of-its-kind
infusion therapy to prevent migraines. Enrollment is on track for
PROMISE 2, our second pivotal Phase 3 study that focuses on chronic
migraine, and we remain on track to submit our BLA with the U.S.
Food and Drug Administration (FDA) in the second half of 2018.”
Migraine is a disabling neurological disease.1 Current
preventive treatments for migraine are challenged by safety,
efficacy, and tolerability limitations and fail to meet the needs
of most patients.2,3 Migraine preventive treatments can take
weeks to months to achieve meaningful clinical benefit and,
subsequently, most patients discontinue within 6 months to 1 year
due to lack of efficacy and/or side effects.3,4 The eptinezumab
development program was designed to redefine physician and patient
expectations for migraine prevention. This includes early,
meaningful, sustained migraine prevention including the opportunity
for patients to experience long periods of migraine
freedom.
About PROMISE 1 and 2 PROMISE 1
(PRevention Of
Migraine via Intravenous
eptinezumab Safety and Efficacy
1) is a double-blind, randomized, placebo-controlled Phase 3 study
evaluating the efficacy and safety of eptinezumab (300mg, 100mg or
30mg) administered by intravenous infusion once every 12 weeks
through week 24. The study continues for an additional 2 doses
every 12 weeks with follow up through week 56. The study enrolled
888 patients diagnosed with frequent episodic migraine. The primary
endpoint for PROMISE 1 was the mean change in monthly migraine days
from baseline (28-day run-in period) for weeks 1 through 12. Key
secondary endpoints included the percent of patients who achieved
≥75% reduction in monthly migraine days from baseline over weeks 1
through 4 and weeks 1 through 12. Patients enrolled in the
study experienced, on average, 8.6 migraines days per month.
Alder expects to complete enrollment in PROMISE 2, which is
being conducted in patients with chronic migraine, later this year.
Top-line data for that study are expected in the first half of
2018. Together, the results of PROMISE 1, PROMISE 2, and an
open-label safety study will support a Biologics License
Application (BLA) submission to the FDA for eptinezumab, which
Alder plans to file in the second half of 2018.
About Eptinezumab Eptinezumab is an
investigational monoclonal antibody discovered and developed by
Alder BioPharmaceuticals for migraine prevention. Eptinezumab is
administered quarterly via infusion that allows for 100% of the
dose available to selectively and potently inhibit CGRP.5
Eptinezumab is currently in multiple global, randomized
pivotal, Phase 3 studies to assess its efficacy and safety in
migraine prevention.
About Migraine1,2,3 Migraine affects 36 million
Americans and is considered the 6th most disabling disease in the
world. It is a disabling neurological disease characterized by
recurrent episodes of moderate to severe headache accompanied by
nausea, vomiting, and sensitivities to light and sound. 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.
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 there is a significant need for new,
effective, and well-tolerated treatment options.
Conference Call and WebcastAlder will host a
conference call and live audio webcast today at 8:00 a.m. ET to
discuss PROMISE 1 top-line data. The live call may be accessed by
dialing (877) 430-4657 for domestic callers or (484) 756 4339 for
international callers, and providing conference ID number 46152061.
The webcast and accompanying slides may be accessed from the Events
& Presentations page in the Investors section of Alder’s
website at www.alderbio.com and will be available for replay
following the call for 30 days.
About Alder BioPharmaceuticalsAlder
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 for migraine prevention.
Eptinezumab is a monoclonal antibody administered quarterly via
infusion that allows for 100% of the dose available to selectively
and potently inhibit the 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; the
availability of results from clinical trials; the potential
regulatory submission for eptinezumab; the high unmet need for
preventative migraine treatments; and Alder’s goals and
objectives. Words such as “will,” “could,” “advance,” “goal,”
“potential,” “support,” “unique,” “first-of-its-kind,” “on track,”
“expects,” “plans,” 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
quarter 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.
References
- Migraine Research Foundation. Migraine
Facts. http://www.migraineresearchfoundation.org/fact-sheet.html.
Accessed June 17, 2017.
- Lipton RB, Silberstein SD. Episodic and chronic migraine
headache: breaking down barriers to optimal treatment and
prevention. Headache. 2015; 55(S2):103-122.
- 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.
- 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.
Media Contacts:
Tony Russo
Russo Partners, LLC
(212) 845-4251
tony.russo@russopartnersllc.com
Investor Relations Contact:
David Walsey
Alder Biopharmaceuticals
(425) 408-8032
ir@alderbio.com
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