Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical
company focused on developing novel therapeutic antibodies for the
treatment of migraine, today announced a new analysis of
patient-reported outcomes data from the PROMISE-2 Phase 3 clinical
trial of eptinezumab for the prevention of chronic migraine.
Eptinezumab is an investigational monoclonal antibody (mAb)
targeting the calcitonin gene-related peptide (CGRP) administered
by quarterly infusion for migraine prevention. The new analysis
showed improvements in most bothersome migraine symptoms and
patients’ global impression of change in their migraine status by
Month 1 after treatment, with improvements sustained or increased
through the first and second quarterly infusion. Detailed data will
be presented today at the 71st AAN Annual Meeting in Philadelphia,
PA.
“This innovative study and compelling outcomes is a reflection
of the commitment Alder has made to advance our understanding of
the experience and the areas of improvement that matter most to the
millions of people living with migraine,” said Paul Streck, M.D.,
chief medical officer of Alder. “We know that migraine is not just
a headache. It can bring disabling symptoms including those
reported in the study, such as extreme pain, nausea, vomiting,
sensitivities to light and sound, and mental cloudiness and
fatigue. We are pleased that the benefits seen in these
patient-reported outcomes build on the body of clinical data
supporting the potential of eptinezumab as a meaningful treatment
option, if approved.”
The analysis evaluated the impact of 100 mg and 300 mg doses of
eptinezumab vs. placebo on measures of patient-reported most
bothersome symptom (MBS) as well as patients’ global impression of
change (PGIC) in their overall migraine status. This study
represents the first time patient-reported MBS data has been
reported in a chronic migraine prevention study.
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.
Highlights from the data analysis include1:
- At Month 1 after treatment:
- 45% of patients treated with 100 mg of eptinezumab and 57% of
patients treated with 300 mg of eptinezumab indicated their MBS was
much improved or very much improved vs. 29% of patients receiving
placebo
- 45% of patients treated with 100 mg of eptinezumab and 59% of
patients treated with 300 mg of eptinezumab indicated their PGIC
was much improved or very much improved vs. 32% of patients
receiving placebo
- At Month 6, three months after the second quarterly infusion:
- 57% of patients treated with 100 mg of eptinezumab and 57% of
patients treated with 300 mg of eptinezumab indicated their MBS was
much improved or very much improved vs. 42% of patients receiving
placebo
- 60% of patients treated with 100 mg of eptinezumab and 60% of
patients treated with 300 mg of eptinezumab indicated their PGIC
was much improved or very much improved vs. 41% of patients
receiving placebo
- Eptinezumab’s effect on a patient’s MBS was highly correlated
with the patient’s impression of improvement in their overall
migraine disease. The correlation was greater than what is observed
with more standard measures such as mean monthly migraine
days.
“Migraine is a highly symptomatic disease and my patients are
seeking relief not just from the migraine pain itself, but also the
many debilitating symptoms that can have a significant impact on
their quality of life,” said Richard Lipton, M.D., director of the
Montefiore Headache Center, Albert Einstein College of Medicine. “A
treatment that can provide the rapid, robust and sustained
suppression of CGRP for migraine prevention as demonstrated in
eptinezumab studies, while also improving patient-reported outcomes
including symptom control, has the potential to provide a
beneficial new option for patients with migraine, if approved.”
The U.S. Food and Drug Administration accepted Alder’s Biologics
License Application 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
infusion anti-CGRP 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 endpoints 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 the CGRP for the prevention of migraine. If approved
by the U.S. Food and Drug Administration, it will be the first
quarterly, anti-CGRP 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,” “compelling,” “benefits,” “build,”
“potential,” “option,” “can,” 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 Lipton R, McGill L, Hirman J, Biondi D, Cady R; Patient Global
Impression of Change Related to Improvement in Most Bothersome
Symptom Following Treatment With Eptinezumab. Presented at the
American Academy of Neurology (AAN) 2019 Annual Meeting.
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