Alder BioPharmaceuticals® Presents New Six-Month Data for Eptinezumab Demonstrating Improvement in Efficacy in PROMISE 2 Phase 3 Trial for Chronic Migraine
- Data presented today at the American Headache Society (AHS) Annual Scientific Meeting demonstrate43% of patients receiving 300 mg of eptinezumab achieved a 75% or greater reduction of monthly migraine days
- 1 in 5 patients were migraine free (achieved 100% response) on average per month following the second infusion of eptinezumab
BOTHELL, Wash., June 29, 2018 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, announced today new six-month data from its PROMISE 2 Phase 3 clinical trial in patients with chronic migraine following a second quarterly infusion of eptinezumab. The data show that patients experienced a reduction of 8.8 monthly migraine days (MMDs) from baseline following the second quarterly infusion of 300 mg of eptinezumab. These results demonstrate a further numerical improvement in efficacy over the first infusion which resulted in a reduction from baseline of 8.2 MMDs in this trial. Eptinezumab is Alder’s lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide (CGRP). Detailed results will be presented today at the 60th AHS Annual Scientific Meeting in San Francisco, CA.
“These data further add to the significant body of clinical evidence supporting eptinezumab’s encouraging clinical profile and reinforce our belief in the value it may provide to patients, if approved” said Robert Azelby, chief executive officer of Alder. “The robust efficacy shown over the two quarterly infusions of eptinezumab in chronic migraine patients continues to support eptinezumab’s potential as an important treatment option for patients living with this debilitating condition.”
Highlights from PROMISE 2 Trial Following First and Second Infusions:
- After the first quarterly infusion, patients dosed with 300 mg of eptinezumab experienced 8.2 fewer MMDs, from a baseline of 16 MMDs, compared to 5.6 fewer MMDs for placebo from baseline (p value <.0001). A further reduction in MMDs was seen following a second infusion; 8.8 fewer MMDs for patients dosed with 300 mg compared to 6.2 fewer MMDs for those with placebo.*
- Approximately 21 percent of patients achieved, on average, 100 percent reduction of MMDs from baseline compared to 9 percent for placebo after two quarterly infusions of 300 mg of eptinezumab.
- 64 percent of patients achieved 50 percent or greater reduction of MMDs from baseline, compared to 44 percent for placebo; and 43 percent of patients achieved 75 percent or greater reduction of MMDs from baseline, compared to 24 percent for placebo after two quarterly infusions.
- There were no new safety findings observed with the second quarterly infusion.
“The efficacy data following two quarterly infusions from the PROMISE 2 trial demonstrate eptinezumab’s potential to offer both rapid and sustained suppression of migraine that is further improved for patients whose quality of life is severely impacted by this condition,” said Richard Lipton, M.D., Director of the Montefiore Headache Center, Albert Einstein College of Medicine. “My patients could potentially see great benefit from a treatment that can provide the level of efficacy seen with eptinezumab in the clinical studies.”
The observed safety profile for PROMISE 2, to date, is consistent with previously reported eptinezumab studies. Adverse event rates among eptinezumab-treated subjects were similar to placebo-treated subjects. The most commonly reported adverse events for eptinezumab, occurring at an incidence of 2.0 percent or greater and greater than placebo were: nasopharyngitis (common cold) (7.4 percent), urinary tract infection (2.8 percent), nausea (2.5 percent), arthralgia (2.3 percent), dizziness (2.0 percent), and fatigue (2.0 percent).
Migraine is a highly symptomatic and debilitating disease affecting a large patient population.1 Preventative treatments, if effective, may take weeks to months to achieve meaningful clinical benefits, and fail to meet the needs of most patients.2 Further, up to 80 percent of patients discontinue use within six months to a year due to lack of efficacy and/or side effects.3,4
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 percent bioavailability to immediately inhibit CGRP.5 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, patients were randomized and 888 received eptinezumab (300 mg, 100 mg or 30mg), 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 at least 75 percent and at least 50 percent responder rates, proportion of patients experiencing migraine on the day following administration, and those assessed through week 24 include at least 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, patients were randomized and 1,072 received eptinezumab (300 mg or 100 mg), 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 proportion of patients experiencing migraine on the day following administration 6 and reduction of migraine prevalence 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.
Migraine affects 36 million Americans1 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 50.7 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.3,4,8 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.
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 “demonstrate,” “show,” “encouraging,” “reinforce,” “belief,” “value,” “may,” “continue,” “potential,” “option,” “need,” “can,” “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 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.
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* Eptinezumab’s efficacy was not statistically compared against Placebo.
1 Migraine Research Foundation. Migraine Facts. https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed April 16, 2018.
2 Parsekyan D. Migraine prophylaxis in adult patients. West J Med. 2000;173(5):341-345.
3 Hepp Z, Dodick DW, Varon SF, et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015;35(6):477-488.
4 Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015;55(S2):103-122.
5 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.
6 Day One prevalence rate comparison between eptinezumab vs. placebo.
7 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).
8 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.
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