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BOTHELL, Wash., May 06, 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 efficacy data highlighting consistency of early migraine prevention benefit across four clinical trials with eptinezumab. Eptinezumab is an investigational monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) and is administered by quarterly infusion for migraine prevention. Detailed data will be presented today at the 71st AAN Annual Meeting in Philadelphia, PA.
Across the Phase 2 and Phase 3 clinical trials, it was observed that eptinezumab, facilitated by its 100% bioavailability at the end of infusion, showed a rapid onset of migraine prevention. The rapid response observed within Day 1 and Month 1 was sustained through the first quarter following infusion, maintained or further increased through subsequent infusions and consistent across four clinical trials. 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.
“I’m excited to see the early onset migraine prevention that eptinezumab can potentially bring to millions of people who are impacted by this debilitating disease,” said Roger K. Cady, M.D., vice president, neurology of Alder BioPharmaceuticals. “During my time in clinical practice, my patients with migraine were consistently looking for new treatment options. These data continue to support the potential of eptinezumab to be a meaningful treatment option for those impacted with the burden of migraine, if approved.”
Highlights from the Phase 3 Early Relief Data include 1 :
The U.S. Food and Drug Administration (FDA) accepted Alder’s Biologics License Application (BLA) 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, anti-CGRP infusion therapy for migraine prevention.
About the 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 (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 endpoint 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.
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 CGRP for the prevention of migraine. If approved by the U.S. Food and Drug Administration, it will be the first quarterly 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.
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,” “can,” “potentially,” “continue,” “support,” 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.
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1 Dodick D, Smith T, Cady R, et al; Eptinezumab Demonstrates Early Relief from Episodic and Chronic Migraine: Consistency of Effect Across 4 Clinical Trials. Presented at the American Academy of Neurology (AAN) 2019 Annual Meeting.