- Data presented at the 2019 American Academy of Neurology (AAN) meeting demonstrate nearly 60% of patients reported very much or much improvement in most bothersome symptoms and in overall migraine status following two treatments with eptinezumab -
- Study represents first time most bothersome symptom data has been reported in a chronic migraine prevention study -
BOTHELL, Wash., May 08, 2019 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced a new analysis of patient-reported outcomes data from the PROMISE-2 Phase 3 clinical trial of eptinezumab for the prevention of chronic migraine. Eptinezumab is an investigational monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) administered by quarterly infusion for migraine prevention. The new analysis showed improvements in most bothersome migraine symptoms and patients’ global impression of change in their migraine status by Month 1 after treatment, with improvements sustained or increased through the first and second quarterly infusion. Detailed data will be presented today at the 71st AAN Annual Meeting in Philadelphia, PA.
“This innovative study and compelling outcomes is a reflection of the commitment Alder has made to advance our understanding of the experience and the areas of improvement that matter most to the millions of people living with migraine,” said Paul Streck, M.D., chief medical officer of Alder. “We know that migraine is not just a headache. It can bring disabling symptoms including those reported in the study, such as extreme pain, nausea, vomiting, sensitivities to light and sound, and mental cloudiness and fatigue. We are pleased that the benefits seen in these patient-reported outcomes build on the body of clinical data supporting the potential of eptinezumab as a meaningful treatment option, if approved.”
The analysis evaluated the impact of 100 mg and 300 mg doses of eptinezumab vs. placebo on measures of patient-reported most bothersome symptom (MBS) as well as patients’ global impression of change (PGIC) in their overall migraine status. This study represents the first time patient-reported MBS data has been reported in a chronic migraine prevention study.
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.
Highlights from the data analysis include1:
- At Month 1 after treatment:
- 45% of patients treated with 100 mg of eptinezumab and 57% of patients treated with 300 mg of eptinezumab indicated their MBS was much improved or very much improved vs. 29% of patients receiving placebo
- 45% of patients treated with 100 mg of eptinezumab and 59% of patients treated with 300 mg of eptinezumab indicated their PGIC was much improved or very much improved vs. 32% of patients receiving placebo
- At Month 6, three months after the second quarterly infusion:
- 57% of patients treated with 100 mg of eptinezumab and 57% of patients treated with 300 mg of eptinezumab indicated their MBS was much improved or very much improved vs. 42% of patients receiving placebo
- 60% of patients treated with 100 mg of eptinezumab and 60% of patients treated with 300 mg of eptinezumab indicated their PGIC was much improved or very much improved vs. 41% of patients receiving placebo
- Eptinezumab’s effect on a patient’s MBS was highly correlated with the patient’s impression of improvement in their overall migraine disease. The correlation was greater than what is observed with more standard measures such as mean monthly migraine days.
“Migraine is a highly symptomatic disease and my patients are seeking relief not just from the migraine pain itself, but also the many debilitating symptoms that can have a significant impact on their quality of life,” said Richard Lipton, M.D., director of the Montefiore Headache Center, Albert Einstein College of Medicine. “A treatment that can provide the rapid, robust and sustained suppression of CGRP for migraine prevention as demonstrated in eptinezumab studies, while also improving patient-reported outcomes including symptom control, has the potential to provide a beneficial new option for patients with migraine, if approved.”
The U.S. Food and Drug Administration accepted Alder’s Biologics License Application 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 infusion anti-CGRP 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 endpoints 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 the CGRP for the prevention of migraine. If approved by the U.S. Food and Drug Administration, it will be the first quarterly, anti-CGRP 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,” “compelling,” “benefits,” “build,” “potential,” “option,” “can,” 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 Lipton R, McGill L, Hirman J, Biondi D, Cady R; Patient Global Impression of Change Related to Improvement in Most Bothersome Symptom Following Treatment With Eptinezumab. Presented at the American Academy of Neurology (AAN) 2019 Annual Meeting.