Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical
company focused on developing novel therapeutic antibodies for the
treatment of migraine, today announced new efficacy data
highlighting consistency of early migraine prevention benefit
across four clinical trials with eptinezumab. Eptinezumab is an
investigational monoclonal antibody (mAb) targeting the calcitonin
gene-related peptide (CGRP) and is administered by quarterly
infusion for migraine prevention. Detailed data will be presented
today at the 71st AAN Annual Meeting in Philadelphia, PA.
Across the Phase 2 and Phase 3 clinical trials, it was observed
that eptinezumab, facilitated by its 100% bioavailability at the
end of infusion, showed a rapid onset of migraine prevention. The
rapid response observed within Day 1 and Month 1 was sustained
through the first quarter following infusion, maintained or further
increased through subsequent infusions and consistent across four
clinical trials. Safety and tolerability were evaluated in
the eptinezumab clinical trials. No serious adverse drug reactions
related to eptinezumab were identified within the clinical trial
program.
“I’m excited to see the early onset migraine prevention that
eptinezumab can potentially bring to millions of people who are
impacted by this debilitating disease,” said Roger K. Cady, M.D.,
vice president, neurology of Alder BioPharmaceuticals. “During my
time in clinical practice, my patients with migraine were
consistently looking for new treatment options. These data continue
to support the potential of eptinezumab to be a meaningful
treatment option for those impacted with the burden of migraine, if
approved.”
Highlights from the Phase 3 Early Relief Data
include1:
- Episodic Migraine:
- 52.3% reduction in the percentage of patients with a migraine
on Day 1 in those treated with 100 mg eptinezumab and 54.9% in
those treated with 300 mg eptinezumab compared to 24.5% for
placebo
- Chronic Migraine:
- 50.3% reduction in the percentage of patients with a migraine
on Day 1 in those treated with 100 mg eptinezumab and 51.6% in
those treated with 300 mg eptinezumab compared to 27.1% for
placebo
The U.S. Food and Drug Administration (FDA) accepted Alder’s
Biologics License Application (BLA) for eptinezumab in April 2019,
with a Prescription Drug User Fee Act (PDUFA) target action date of
February 21, 2020. If approved, it will be the first quarterly,
anti-CGRP infusion therapy for migraine prevention.
About the Eptinezumab PROMISE Clinical Trial
ProgramPROMISE-1 (PRevention Of Migraine via Intravenous
eptinezumab Safety and Efficacy-1) was a Phase 3 randomized,
double-blind, placebo-controlled global trial evaluating the safety
and efficacy of eptinezumab for episodic migraine prevention. In
the study, patients were randomized and 888 received eptinezumab
(30 mg, 100 mg or 300 mg) or placebo, administered by infusion once
every 12 weeks. To be eligible for the trial, patients must have
experienced at most 14 headache days per month, of which at least
four met the criteria for migraine. The primary endpoint was the
mean change from baseline in monthly migraine days over the 12-week
treatment period. Secondary study endpoints include at least 75%
and at least 50% responder rates assessed through 12 weeks, and
percentage of patients experiencing migraine on the day following
administration. In June 2017, Alder announced that
eptinezumab met the primary endpoint and key secondary endpoints in
PROMISE-1.
PROMISE-2 (PRevention Of Migraine via Intravenous ALD403 Safety
and Efficacy-2) was a Phase 3, randomized, double-blind,
placebo-controlled global trial evaluating the safety and efficacy
of eptinezumab for chronic migraine prevention. In the study,
patients were randomized and 1,072 received eptinezumab (100 mg or
300 mg) or placebo, administered by infusion once every 12 weeks.
To be eligible for the trial, patients must have experienced at
least 15 headache days per month, of which at least eight met the
criteria for migraine. Patients that participated in the trial had
an average of 16.1 migraine days per month at baseline. The primary
endpoint was the mean change from baseline in monthly migraine days
over the 12-week, double-blind treatment period. Secondary study
endpoints included percentage of patients experiencing migraine on
the day following administration and reduction of migraine
prevalence days 1-28, reduction of at least 50%, 75%, and 100% from
baseline in mean monthly migraine days assessed through 12 weeks,
change from baseline in mean monthly acute migraine-specific
medication days, and reductions from baseline in patient-reported
impact scores on the Headache Impact Test (HIT-6). In January 2018,
Alder announced that eptinezumab met the primary endpoint and key
secondary endpoints in PROMISE-2.
Safety and tolerability were evaluated in the eptinezumab
clinical trials. The most common adverse reaction in the
clinical trials for the preventive treatment of migraine (those
with incidence at least 2% and at least 2% greater than placebo)
was nasopharyngitis (swelling of the nasal passages and the back of
the throat). No serious adverse drug reactions related to
eptinezumab were identified within the clinical trial program.
About Eptinezumab Eptinezumab is an
investigational monoclonal antibody (mAb) discovered and developed
by Alder BioPharmaceuticals for migraine prevention. Eptinezumab
was designed for 100% bioavailability delivered via quarterly
infusion with high specificity and strong binding for rapid,
robust, and sustained suppression of CGRP.
About Alder BioPharmaceuticals, Inc. Alder
BioPharmaceuticals is a clinical-stage biopharmaceutical
company focused on transforming migraine treatment through the
discovery, development and commercialization of novel therapeutic
antibodies. Alder’s lead product candidate, eptinezumab, is an
investigational monoclonal antibody (mAb) delivered by infusion
that inhibits CGRP for the prevention of migraine. If approved by
the U.S. Food and Drug Administration, it will be the first
quarterly infusion therapy for migraine prevention. Alder is
also developing ALD1910, a preclinical mAb that inhibits pituitary
adenylate cyclase-activating polypeptide-38 (PACAP-38) for migraine
prevention. For more information, please
visit 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 need for
new treatment options; the belief that eptinezumab has the
potential to be a meaningful treatment option; the potential
approval by the FDA of the BLA for eptinezumab; Alder’s focus on
transforming migraine treatment; and the development of ALD1910.
Words such as “will,” “can,” “potentially,” “continue,” “support,”
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: 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 the build of Alder’s commercialization
infrastructure; risks and uncertainties relating to the manufacture
and supply of eptinezumab; Alder's ability to obtain and protect
intellectual property rights, and operate without infringing on the
intellectual property rights of others; risks and uncertainties
relating to ongoing and potential future legal proceedings; 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 Quarterly Report on Form 10-Q
for the quarterly period ended March 31, 2019, which was filed with
the Securities and Exchange Commission (SEC) on May 2, 2019, 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.
Investor Relations Contact: Michael Schaffzin
Stern Investor Relations, Inc. 212-362-1200
michael@sternir.com
Media Contact: Ashley Cadle TogoRun
310-463-0143 a.cadle@togorun.com
1 Dodick D, Smith T, Cady R, et al; Eptinezumab Demonstrates
Early Relief from Episodic and Chronic Migraine: Consistency of
Effect Across 4 Clinical Trials. Presented at the American Academy
of Neurology (AAN) 2019 Annual Meeting.
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