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Press Release

Alder BioPharmaceuticals® Presents New 12-Month Data of Eptinezumab in PROMISE 1 Phase 3 Trial Showing Long-Term Reduction in Episodic Migraine


Posted on: 24 Apr 18

- Data presented at AAN Annual Meeting demonstrate eptinezumab further reduces migraine risk following the third and fourth quarterly infusions

- More than 50% of patients achieved a 75% reduction or greater of migraine days

BOTHELL, Wash., April 24, 2018 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced new twelve-month data from its PROMISE 1 Phase 3 clinical trial in episodic migraine patients. The data demonstrated that patients experienced even further reductions in migraine following the third and fourth quarterly infusions at both dose levels (100mg and 300mg) of eptinezumab, Alder’s lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide (CGRP). Detailed results will be presented today at the 70th Annual American Academy of Neurology Meeting in Los Angeles.

“These results show eptinezumab’s potential to further reduce migraine risk after 12 months and reinforces the demonstrated clinical profile for migraine prevention from our earlier PROMISE 1, 6-month data,” said Roger K. Cady, M.D., Alder Vice President of Neurology. “The strength of the data supports our belief that eptinezumab, if approved, has the potential to be an important treatment option for the millions of patients living with the debilitating effects of migraine.”

PROMISE 1 Results Following Third and Fourth Eptinezumab Infusions

Key points:

Responder rates for month six through month twelve:

  • 70.7 percent of patients achieved on average a 50 percent reduction or greater of monthly migraine days from baseline compared to 58.7 percent for placebo. This represents an 8.9% improvement from the reductions experienced during the first two quarterly doses of eptinezumab;
  • 51.5 percent of patients achieved on average a 75 percent reduction or greater of monthly migraine days from baseline compared to 38.7 percent for placebo. This represents a 12.8% improvement from the reductions experienced during the first two quarterly doses of eptinezumab

“I am very excited to see the encouraging results in migraine prevention shown in the PROMISE 1 long-term data,” said Stephen D. Silberstein, M.D., Professor of Neurology and Director of the Jefferson Headache Center, Thomas Jefferson University. “I see a significant need for my patients for a treatment that provides rapid, effective, well-tolerated and long-term results and I’m looking forward to the FDA’s review of these data.”

The observed safety profile for PROMISE 1, to date, is consistent with previously reported eptinezumab studies. The most commonly reported adverse events occurring at an incidence of 5 percent or greater across all eptinezumab treatment groups were upper respiratory infection (10.5 percent), nasopharyngitis (common cold) (6.8 percent) and sinusitis (3.6 percent).

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 £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, double-blind treatment period. 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 OMigraine 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 reduction in migraine prevalence day 11 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 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.2 Eptinezumab has been studied in several global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention.

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.3 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 monoclonal antibody (mAb) that inhibits calcitonin gene-related peptide (CGRP) and is currently in late-stage clinical development for the prevention of migraine. Unlike other CGRP inhibitors, eptinezumab was specifically designed as an infusion therapy to address significant patient need. 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; eptinezumab’s potential to be an important treatment option in migraine prevention; the impact of the referenced data and results presented; and the significant need for new treatment options. Words such as “will,” “potential,” “reinforces,” “supports,” “option,” “encouraging,” “need,” “looking forward,” 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 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.

References

  1. Day One prevalence rate comparison between eptinezumab vs. placebo
  2. 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: American Academy of Neurology (AAN) 2017 Annual Meeting. April 22-28, 2017; Boston, MA.
  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.

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:
Andy Brimmer / Aura Reinhard / Trevor Gibbons
Joele Frank, Wilkinson Brimmer Katcher
212-355-4449
areinhard@joelefrank.com
tgibbons@joelefrank.com

GlobeNewswire
globenewswire.com

Last updated on: 24/04/2018

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