- Data analyses from clinical trials to highlight eptinezumab’s efficacy and early, sustained quality of life improvements in the prevention of chronic migraine -
- Preclinical data also to be presented for ALD1910, Alder’s second candidate for migraine, demonstrating its binding and selectivity to pituitary adenylate cyclase-activating peptide -
“We continue to be encouraged by the positive data for both eptinezumab and ALD1910, representing two encouraging approaches to migraine prevention and reflecting progress in Alder’s dedication to forever transform migraine treatment,” said
Eptinezumab is an investigational molecule under evaluation for the preventive treatment of migraine in adults.
Eptinezumab was designed for 100% bioavailability with high specificity and strong binding for targeted suppression of calcitonin gene-related peptide (CGRP). In a late-breaking poster presentation, an analysis will demonstrate eptinezumab’s deliberate design and engineering. Additionally, an oral presentation will demonstrate that a single IV administration of eptinezumab (100 mg or 300 mg)1 provided meaningful reductions in headache impact for chronic migraine patients measured at Month 1 and Month 3 compared to placebo, per the HIT-6 patient-reported measure of headache impact on daily life. A second oral presentation will cover a population pharmacokinetics analysis supporting IV administration of eptinezumab every 12 weeks, with 100 mg as the minimal clinically meaningful effective dose for migraine prevention.
Additionally, four posters will be presented featuring efficacy and quality of life improvements with eptinezumab demonstrated in various data analyses, and a fifth poster will include a post-hoc analysis supporting the conclusion that response to treatment with eptinezumab is not dependent on a patient’s genetic constitution.
Alder’s second candidate in development for migraine prevention, ALD1910, is designed to inhibit pituitary adenylate cyclase-activating peptide (PACAP), which has emerged as an important target for the treatment of migraine. It is being studied as a potential preventive treatment for those who have an inadequate response to other therapies and could provide another mechanism-specific therapeutic option for people with migraine and their physicians. A late-breaking presentation will feature a preclinical analysis validating that ALD1910 is a selective, high-affinity antibody that demonstrated in vivo functionality and engagement of PACAP.
Overview of Presentations
- Late-Breaker Poster Number LB065: Anti-CGRP Monoclonal Antibody Eptinezumab Does Not Engage Fcy Receptors Involved in ADCC and ADCP, nor Does It Activate the Complement Cascade
- Presenter: Carol J. Rapport, principal scientist,
- Late-Breaker Poster Number LB075: In Vivo Antagonistic Activity and Endogenous Target Engagement of an Anti-PACAP Monoclonal Antibody
Cristina Moldovan Loomis, senior scientist, Alder BioPharmaceuticals
- Oral Presentation Number OR18: HIT-6 Responder Rates After 1 and 3 Months of Eptinezumab Treatment
- Presenter: Dr.
Roger Cady, vice president of neurology, Alder BioPharmaceuticalsand fellow, American Headache Society
- Oral Comms 3 Session:
Saturday, September 7, 10:40-10:50 a.m. GMT, Wicklow Hall 2
- Digital Poster Number DPO32: Population Pharmacokinetics of Eptinezumab for the Preventive Treatment of Migraine
Brian Baker, senior director toxicology and clinical pharmacology, Alder BioPharmaceuticals
- Digital Session:
Saturday, September 7, 3:02-3:08 p.m. GMT, Exhibition Hall Booth 3
- Poster Number PO165: Eptinezumab Increases Days Free from Canonical Migraine-Associated Symptoms Within 1 Month of Treatment in Patients with Chronic Migraine
Peter Goadsby, professor of neurology, King’s College London and University of California, San Francisco
- Poster Number PO167: Patient Global Impression of Change Related to Improvement in Most Bothersome Symptom Following Treatment with Eptinezumab
- Presenter: Dr.
Richard Lipton, director, Montefiore Headache Center, Albert Einstein College of Medicine
- Poster Number PO183: Item Response Theory Analysis of the HIT-6 in Chronic Migraine Population
- Presenter: RJ Wirth, president and managing partner,
Vector Psychometric Group
- Poster Number PO184: Validity Evidence of the HIT-6 Total Score in Sample of Patients with Chronic Migraine
Carrie R. Houts, director of psychometrics, Vector Psychometric Group
- Poster Number PO155: Genetic Assessment of Eptinezumab Response in the Prevention of Migraine
Kira Misura, vice president R&D, Alder BioPharmaceuticals
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 targeted 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
Investor Relations Contact:
Stern Investor Relations, Inc.
1 Neither dose (100 mg or 300 mg of eptinezumab) was found to be statistically superior to the other.
Source: Alder BioPharmaceuticals, Inc.