- Posters presented at the 2019 American Headache Society meeting highlight eptinezumab’s safety profile and suppression of calcitonin gene-related peptide (CGRP) -
- New data show no migraine days experienced for six months or more in 18.1% of episodic migraine patients treated with 100 mg of eptinezumab (over a 12-month period) -
- Over 50% of chronic migraine patients treated with 100 mg of eptinezumab experienced meaningful improvements in the frequency of severe headaches by Month 1 -
BOTHELL, Wash., July 11, 2019 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced new data from post-hoc analyses of its PROMISE-1 and PROMISE-2 Phase 3 clinical trials for eptinezumab, an investigational monoclonal antibody developed for the prevention of migraine. Detailed data will be shared at the American Headache Society’s (AHS) 61st Annual Scientific Meeting in Philadelphia that further support eptinezumab’s clinical profile, including data on migraine-free months, migraine severity and quality of life.
“These new data analyses further validate our belief that, if approved, eptinezumab can provide clinically meaningful improvements for people living with migraine, which is considered the most disabling disease of people in the most productive years of their lives,” said Roger K. Cady, M.D., vice president, neurology of Alder BioPharmaceuticals. “With these new data showing the clinical effects of rapid, robust and sustained suppression of CGRP, we are excited about the potential of eptinezumab to be a compelling new treatment option for migraine prevention.”
The 100% responder rate analyses evaluated the efficacy of eptinezumab in terms of the number of months a patient experienced no migraine days, i.e., the number of migraine-free months, during the one-year study period in the PROMISE-1 trial (four doses of eptinezumab, one every 12 weeks) and the six-month study period in the PROMISE-2 trial (two doses of eptinezumab, one every 12 weeks). At baseline, patients enrolled in PROMISE-1 were experiencing 8.6 mean monthly migraine days per month and patients in PROMISE-2 were experiencing 16.1 mean monthly migraine days per month. Post-hoc analyses were conducted that quantified the number of patients who experienced no migraine days during each month (i.e., a consecutive 28-day period) in the trial study period.
Highlights include:1,[2]
PROMISE-1
- 18.1% of episodic migraine patients treated with 100 mg of eptinezumab and 25.2% of those treated with 300 mg of eptinezumab experienced no migraine days for at least half of the study period (≥six months) compared with 12.6% of placebo-treated patients
- 63.3% of episodic migraine patients treated with 100 mg of eptinezumab and 64.4% of those treated with 300 mg achieved at least one migraine-free month (over the entire one-year study period) compared to 47.7% of those on placebo
PROMISE-2
- 14.0% of chronic migraine patients treated with 100 mg of eptinezumab and 19.1% of those treated with 300 mg of eptinezumab experienced no migraine days for at least half of the study period (≥three months) compared with 4.9% of placebo-treated patients
- 34.6 % of chronic migraine patients treated with 100 mg of eptinezumab and 39.7% of those treated with 300 mg achieved at least one migraine-free month (over the entire six-month study period) compared to 22.4% of those on placebo
- About twice as many patients with chronic migraine were 100% responders with eptinezumab than with placebo during any given month of the trial
A second post-hoc analysis examined eptinezumab’s efficacy in reducing migraine severity, which is a significant contributor to reduced quality of life and increased burden of disease.3 In the PROMISE-2 trial for chronic migraine, impact scores as measured by the Headache Impact Test (HIT-6) were significantly elevated at baseline. The analysis, conducted within PROMISE-2, evaluated the efficacy and related functional and health-related quality of life outcomes of eptinezumab in those patients enrolled in the trial who, during a screening, reported very often or always experiencing severe headaches (64.7%) per HIT-6.
Efficacy endpoints that were evaluated included: change from baseline in HIT-6 total score and frequency of severe pain during headaches, as well as change from baseline in the 36-item Short-Form Health Survey (SF-36), which is a general measure of health-related quality of life.
Highlights include:2,[4]
- Over half of eptinezumab-treated patients experienced ≥one-category decrease in the frequency of severe headaches by Month 1, compared to 43.7% for placebo. The decrease for patients treated with eptinezumab or placebo remained relatively consistent through the six-month study period.
- Eptinezumab treatment resulted in clinically meaningful improvements in HIT-6 scores as early as Month 1 after treatment, which were maintained or further improved throughout the six-month study period, compared to placebo, which did not achieve a clinically meaningful improvement until Month 6. In addition, eptinezumab treatment resulted in clinically meaningful improvements greater than placebo in SF-36 scores as early as Month 1 after treatment and through the six-month study period.
Additionally, Alder will unveil a visual representation of eptinezumab that enriches the understanding of how the molecule was designed to interact with high specificity and strong binding to the CGRP ligand, which may contribute to the rapid onset of efficacy and sustained prevention observed in the clinical trials. Other key posters to be presented at the meeting include additional quality of life data showing early and sustained improvements in the HIT-6 impact rating total score in patients with chronic migraine in the PROMISE-2 trial, as well as data from the open-label Phase 3 PREVAIL trial showing reduction of migraine disability for patients with chronic migraine treated with eptinezumab.
Safety and tolerability were evaluated in all the eptinezumab clinical trials with no serious adverse drug reactions related to eptinezumab identified within the clinical trial program. The U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for eptinezumab in April 2019 and set a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2020. If approved, eptinezumab will be the first-to-market intravenous (IV) therapy for migraine prevention.
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. The company’s mission is to forever change migraine treatment and give people with migraine their lives back. In 2019, Alder was ranked 19th among the top 100 fastest growing companies in Seattle by Growjo.
Eptinezumab, Alder’s lead product candidate for migraine prevention, is an investigational monoclonal antibody (mAb) that is delivered via IV and designed for 100% bioavailability with high specificity and strong binding for suppression of calcitonin gene-related peptide (CGRP). If approved by the U.S. Food and Drug Administration, it will be the first IV therapy for migraine prevention. Alder is also developing ALD1910, a preclinical mAb designed to inhibit 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 potential approval by the FDA of the BLA for eptinezumab; the continued development of eptinezumab and the development of ALD1910; the clinical, therapeutic and commercial potential of eptinezumab; the belief that eptinezumab has the potential to be a compelling treatment option; and Alder’s mission to forever change migraine treatment and give people with migraine their lives back. Words such as “will,” “support,” “belief,” “excited,” “potential,” “option,” “may,” 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 and ALD1910; 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 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; 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.
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1 Winner P, McGill L, McAllister P, Cady R, Snapinn S, Hirman J, Kassel E; Migraine-Free Months in Patients With Episodic or Chronic Migraine Treated With Eptinezumab: Results From the PROMISE-1 and PROMISE-2 Trials. Presented at the American Headache Society (AHS) 2019 Annual Meeting.
2 Neither dose (100 mg or 300 mg of eptinezumab) was found to be statistically superior to the other.
3 Dowson AJ. Curr Med Res Opin. 2001. doi: 10.1185/0300799019117017
4 Jim Nagy A, Silberstein S, Cady R, Kassel E, Hirman J, Smith J; Treatment With Eptinezumab Demonstrated Meaningful Improvements in Patients With Chronic Migraine Experiencing a High Frequency of Severe Migraines. Presented at the American Headache Society (AHS) 2019 Annual Meeting.