- Posters presented at the 2019
- New data show no migraine days experienced for six months or more in 18.1% of episodic migraine patients treated with 100 mg of eptinezumab (over a 12-month period) -
- Over 50% of chronic migraine patients treated with 100 mg of eptinezumab experienced meaningful improvements in the frequency of severe headaches by Month 1 -
“These new data analyses further validate our belief that, if approved, eptinezumab can provide clinically meaningful improvements for people living with migraine, which is considered the most disabling disease of people in the most productive years of their lives,” said
The 100% responder rate analyses evaluated the efficacy of eptinezumab in terms of the number of months a patient experienced no migraine days, i.e., the number of migraine-free months, during the one-year study period in the PROMISE-1 trial (four doses of eptinezumab, one every 12 weeks) and the six-month study period in the PROMISE-2 trial (two doses of eptinezumab, one every 12 weeks). At baseline, patients enrolled in PROMISE-1 were experiencing 8.6 mean monthly migraine days per month and patients in PROMISE-2 were experiencing 16.1 mean monthly migraine days per month. Post-hoc analyses were conducted that quantified the number of patients who experienced no migraine days during each month (i.e., a consecutive 28-day period) in the trial study period.
- 18.1% of episodic migraine patients treated with 100 mg of eptinezumab and 25.2% of those treated with 300 mg of eptinezumab experienced no migraine days for at least half of the study period (≥six months) compared with 12.6% of placebo-treated patients
- 63.3% of episodic migraine patients treated with 100 mg of eptinezumab and 64.4% of those treated with 300 mg achieved at least one migraine-free month (over the entire one-year study period) compared to 47.7% of those on placebo
- 14.0% of chronic migraine patients treated with 100 mg of eptinezumab and 19.1% of those treated with 300 mg of eptinezumab experienced no migraine days for at least half of the study period (≥three months) compared with 4.9% of placebo-treated patients
- 34.6 % of chronic migraine patients treated with 100 mg of eptinezumab and 39.7% of those treated with 300 mg achieved at least one migraine-free month (over the entire six-month study period) compared to 22.4% of those on placebo
- About twice as many patients with chronic migraine were 100% responders with eptinezumab than with placebo during any given month of the trial
A second post-hoc analysis examined eptinezumab’s efficacy in reducing migraine severity, which is a significant contributor to reduced quality of life and increased burden of disease.3 In the PROMISE-2 trial for chronic migraine, impact scores as measured by the Headache Impact Test (HIT-6) were significantly elevated at baseline. The analysis, conducted within PROMISE-2, evaluated the efficacy and related functional and health-related quality of life outcomes of eptinezumab in those patients enrolled in the trial who, during a screening, reported very often or always experiencing severe headaches (64.7%) per HIT-6.
Efficacy endpoints that were evaluated included: change from baseline in HIT-6 total score and frequency of severe pain during headaches, as well as change from baseline in the 36-item
- Over half of eptinezumab-treated patients experienced ≥one-category decrease in the frequency of severe headaches by Month 1, compared to 43.7% for placebo. The decrease for patients treated with eptinezumab or placebo remained relatively consistent through the six-month study period.
- Eptinezumab treatment resulted in clinically meaningful improvements in HIT-6 scores as early as Month 1 after treatment, which were maintained or further improved throughout the six-month study period, compared to placebo, which did not achieve a clinically meaningful improvement until Month 6. In addition, eptinezumab treatment resulted in clinically meaningful improvements greater than placebo in SF-36 scores as early as Month 1 after treatment and through the six-month study period.
Additionally, Alder will unveil a visual representation of eptinezumab that enriches the understanding of how the molecule was designed to interact with high specificity and strong binding to the CGRP ligand, which may contribute to the rapid onset of efficacy and sustained prevention observed in the clinical trials. Other key posters to be presented at the meeting include additional quality of life data showing early and sustained improvements in the HIT-6 impact rating total score in patients with chronic migraine in the PROMISE-2 trial, as well as data from the open-label Phase 3 PREVAIL trial showing reduction of migraine disability for patients with chronic migraine treated with eptinezumab.
Safety and tolerability were evaluated in all the eptinezumab clinical trials with no serious adverse drug reactions related to eptinezumab identified within the clinical trial program.
Eptinezumab, Alder’s lead product candidate for migraine prevention, is an investigational monoclonal antibody (mAb) that is delivered via IV and designed for 100% bioavailability with high specificity and strong binding for suppression of calcitonin gene-related peptide (CGRP). If approved by the
This press release contains forward-looking statements, including, without limitation, statements relating to: the potential approval by the
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1 Winner P, McGill L, McAllister P, Cady R, Snapinn S, Hirman J, Kassel E; Migraine-Free Months in Patients With Episodic or Chronic Migraine Treated With Eptinezumab: Results From the PROMISE-1 and PROMISE-2 Trials. Presented at the American Headache Society (AHS) 2019 Annual Meeting.
2 Neither dose (100 mg or 300 mg of eptinezumab) was found to be statistically superior to the other.
3 Dowson AJ. Curr Med Res Opin. 2001. doi: 10.1185/0300799019117017
4 Jim Nagy A, Silberstein S, Cady R, Kassel E, Hirman J, Smith J; Treatment With Eptinezumab Demonstrated Meaningful Improvements in Patients With Chronic Migraine Experiencing a High Frequency of Severe Migraines. Presented at the American Headache Society (AHS) 2019 Annual Meeting.
Source: Alder BioPharmaceuticals, Inc.