New eptinezumab data at two late-breaking sessions demonstrate efficacy that is sustained and further improved after repeat treatments

BOTHELL, Wash., June 20, 2018 (GLOBE NEWSWIRE) -- 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 updated data from the PROMISE 1 and PROMISE 2 phase 3 clinical trials for eptinezumab, Alder's lead investigational product candidate for migraine prevention, at the upcoming American Headache Society (AHS) annual scientific meeting at the Marriott Marquis in San Francisco, CA (June 28 – July 1, 2018).

Eptinezumab data will be presented in multiple late-breaking sessions, platform presentations and poster presentations, and will debut efficacy data from PROMISE 2 for chronic migraine patients who received two quarterly infusions of eptinezumab. Key outcomes from PROMISE 2 will include monthly migraine days, early onset of activity and responder rates (≥50, ≥75 and 100 percent) after two quarterly infusions. The presentations also will include new year-long data from PROMISE 1 evaluating eptinezumab in episodic migraine patients, as well as outcomes of the Short-Form Health Survey Scores in PROMISE 2, which assess quality of life.

“At Alder, we are committed to advancing the treatment paradigm for migraine prevention for patients whose quality-of-life is severely impacted by this debilitating condition,” said Robert Azelby, chief executive officer of Alder. “Our new and compelling efficacy and outcomes data showing a large percentage of patients achieving Day One reductions in migraine risk that is sustained through 12 weeks and also further improves after two or more quarterly infusions, continues to support eptinezumab’s potential to be a meaningful, new treatment option for migraine patients.”

Late-Breaking Studies, Friday, June 29:

Session PF110LB: Display: 6:30 am – 5:00 pm PT; Presentation: 1:15 pm – 2:15 pm PT, Yerba Buena Ballroom

• Eptinezumab for Prevention of Chronic Migraine (CM): Results of 2 Quarterly Intravenous Infusions in the Phase 3 PROMISE-2 (Prevention Of Migraine via Intravenous eptinezumab Safety and Efficacy‒2) Trial
  • Presenter: Dr. Richard Lipton, director, Montefiore Headache Center, Albert Einstein College of Medicine

Session PF108LB: Display: 6:30 am – 5:00 pm PT; Presentation: 1:15 pm – 2:15 pm PT, Yerba Buena Ballroom

• Eptinezumab Results for the Prevention of Episodic Migraine Over One Year in the PROMISE-1 (Prevention Of Migraine via Intravenous eptinezumab Safety and Efficacy‒1) Trial
  • Presenter: Dr. Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center, Thomas Jefferson University

Platform Presentations, Saturday, June 30:

Session IOR03: 8:20 am – 8:30 am PT, Yerba Buena Ballroom

• Eptinezumab Reduced Migraine Activity and Achieved High Migraine Responder Rates over Weeks 1‒12: Results from the Phase 3 PROMISE-2 Trial in Chronic Migraine
  • Presenter: Dr. Paul Winner, director of both the Premiere Research Institute and the Palm Beach Headache Center in West Palm Beach, FL

Session IOR04: 8:30 am – 8:40 am PT, Yerba Buena Ballroom

• Eptinezumab Achieved Meaningful Reductions in Migraine Activity as Early as Day 1: PROMISE-2 (PRevention of Migraine via Intravenous Eptinezumab Safety and Efficacy-2) Phase 3 Trial in Chronic Migraine
  • Presenter: Dr. Roger Cady, vice president of neurology, Alder BioPharmaceuticals and fellow, American Headache Society

                   
Poster Presentations:
All posters displayed Friday, June 29, 6:30 am – 5:00 pm PT; Presentations: 1:15 pm – 2:15 pm PT, Yerba Buena Ballroom

• PF06: Migraine Activity Reductions with Eptinezumab Were Associated with Improvements in Short-Form Health Survey Scores Most Affected by Migraine: Results from Phase 3 PROMISE-2 Trial in Chronic Migraine
  • Presenter: Dr. Joel Saper, founder and director, Michigan Headache and Neurology Institute
     
• PF34: Baseline Population Characteristics of PROMISE-2: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Eptinezumab for Prevention of Chronic Migraine
  • Presenter: Dr. Egilius Spierings, director and principal investigator, MedVadis Research Corporation
     
• PF10: Eptinezumab Reduced Migraine Hours and Severity, Which Were Accompanied by Improved HIT-6 Scores, over Weeks 1‒12: Results from the Phase 3 PROMISE-2 Trial in Chronic Migraine
  • Presenter: Dr. Timothy Smith, medical director, Mercy Health Research, Mercy Medical Group
     
• PF02: A Phase 3 Study to Evaluate 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, Montefiore Headache Center, Albert Einstein College of Medicine
     
• PF20: 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, Jefferson Headache Center, Thomas Jefferson University

E-Poster Presentations:
All e-posters displayed Friday, June 29, 1:55 pm – 2:00 pm PT; Exhibit Hall

• Room 3: Eptinezumab Reduced Migraine Hours and Severity, Which Were Accompanied by Improved HIT-6 Scores, over Weeks 1‒12: Results from the Phase 3 PROMISE-2 Trial in Chronic Migraine
  • Presenter: Dr. Timothy Smith, medical director, Mercy Health Research, Mercy Medical Group
     
• Room 2: A Phase 3 Study to Evaluate 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, Montefiore Headache Center, Albert Einstein College of Medicine

About Eptinezumab
Eptinezumab is an investigational monoclonal antibody discovered and developed by Alder BioPharmaceuticals for migraine prevention. Eptinezumab is the only potent and selective anti-CGRP mAb administered by quarterly infusion for migraine prevention, delivering 100% bioavailability to immediately inhibit CGRP.¹ Eptinezumab has been studied in several global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention.

About Eptinezumab PROMISE Clinical Trial Program
PROMISE 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, 888 patients were randomized to receive eptinezumab (300 mg, 100 mg or 30mg), 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 assessed through 12 weeks include 75 percent and 50 percent responder rates over weeks 1-12, reduction in the proportion of patients experiencing migraine on the day following administration, and those assessed through week 24 include 75 percent and 100 percent responder rates. In June 2017, Alder announced that eptinezumab met the primary endpoint and key secondary endpoints in PROMISE 1 with very high statistical significance. See the press release for more information.

PROMISE 2 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2) is a Phase 3, randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for chronic migraine prevention. In the study, 1,072 patients were randomized to receive eptinezumab (300 mg or 100 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 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 assessed through 12 weeks included patients with migraine prevalence on day 1² and days 1-28, reduction of at least 50%, 75%, and 100% from baseline in mean monthly migraine days, 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 with very high statistical significance. See the press release for more information.

About Migraine
Migraine affects 36 million Americans³ and, worldwide, is considered the sixth-leading cause of days with disability⁴ and the third-leading cause of disability of people under the age of 50.⁵ 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.^6,7 There is a significant need for new, effective, and well-tolerated treatment options.

About Alder BioPharmaceuticals, Inc.
Alder BioPharmaceuticals is a clinical-stage biopharmaceutical company focused on transforming the migraine treatment paradigm through the discovery, development and commercialization of novel therapeutic antibodies. Alder’s lead product candidate, eptinezumab, is a pivotal-stage monoclonal antibody (mAb) that inhibits calcitonin gene-related peptide (CGRP). Eptinezumab is currently in late-stage clinical development and, if approved, will be the first-to-market 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, 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; and Alder’s commitment to transform the treatment paradigm for migraine prevention. Words such as “demonstrate,” “will,” “compelling,” “continues,” “support,” “potential,” “option,” 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 Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2018, which was filed with the Securities and Exchange Commission (SEC) on May 8, 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.

Investor Relations Contact:                                        
Ashwin Agarwal               
Vice President, Corporate Strategy                                                                                                         
Alder Biopharmaceuticals, Inc.
425-408-8567
aagarwal@alderbio.com  

Michael Schaffzin
Stern Investor Relations, Inc.
212-362-1200
michael@sternir.com  

Media Contact:                                                                
Ashley Cadle
TogoRun
310-463-0143
a.cadle@togorun.com

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¹ 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.
² Day One prevalence rate comparison between eptinezumab vs. placebo
³ Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015; 55(S2):103-122.
⁴ Migraine Research Foundation. Migraine Facts. https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed April 16, 2018.
⁵ 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).
⁶ 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.
⁷ 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.