At one year, patients receiving AMG 334 70 mg experienced an average of a -4.9-day reduction from a baseline of 8.7 mean monthly migraine days, regardless of treatment received during the blinded phase. The 50 percent responder rate (greater than 50 percent reduction in monthly migraine days) was 62 percent at 52 weeks. Additional responder rates were reported for the first time: at 52 weeks the 75 percent responder rate was 38 percent and the 100 percent responder rate was 19 percent.
"These long-term data further demonstrate that AMG 334 provided meaningful benefit to these patients with fewer migraine days and more days with the ability to participate in work and social activities each month," said
The open-label portion of the Phase 2 study included 383 patients. All patients received AMG 334 70 mg starting at week 12 for up to 256 weeks. Safety and tolerability were evaluated monthly and this interim analysis includes data up to week 52. Additional efficacy endpoints included the change in monthly migraine-specific medication use days and patient-reported outcomes using the Migraine Disability Assessment (MIDAS) questionnaire.
Patients reported a nearly 50 percent reduction of monthly migraine-specific medication use days of -2 at 52 weeks, from a baseline of 4.3 days per month. In addition to clinical measures, patients self-reported the impact of headache and migraine on their daily activities. At one year, using the MIDAS tool, patients reported an improvement of approximately 12 days over the previous three months in their ability to function in work, home and social situations. According to the
The safety and tolerability profile during the open-label phase was similar to that observed in the blinded phase of the study. The most commonly reported adverse events included fatigue, influenza, nasopharyngitis, arthralgia and back pain. No Grade 4 or 5 adverse events were reported. Serious adverse events were reported in 13 patients, one of which was deemed treatment-related. Less than 5 percent of patients discontinued the study during the open-label phase due to adverse events.
Migraine has been declared one of the top 10 most disabling conditions in the world, with more than 10 percent of the worldwide population suffering from the condition.1 More complex than just a headache, migraines involve incapacitating head pain and physical impairment, frequently accompanied by nausea, vomiting, and aura-related sound or other sensory disturbances.2 Migraine poses a significant burden to society, costing American employers more than
About AMG 334
AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine. AMG 334 targets the calcitonin gene-related peptide (CGRP) receptor, which is believed to transmit signals that can cause incapacitating pain.
AMG 334 is currently under evaluation in several large global, randomized, double-blind, placebo-controlled studies to evaluate its safety and efficacy in migraine prevention.
This news release contains forward-looking statements that are based on the current expectations and beliefs of
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
1 Vos et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. The Lancet. 2012 Dec-2013 Jan;30(9859):2163-2196.
4 Scher Al, Stewart WF, Ricci JA, Lipton RB. Factors associated with the onset and remission of chronic daily headache in a population-based study. Pain. 2003 Nov: 106(102:81-9).
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