AHS Meeting Release C2GRP

Promising Results for First-Ever Preventive Migraine Treatment Class Presented at American Headache Society’s 59th Annual Scientific Meeting

[MOUNT ROYAL, NJ, JUNE 7, 2017] – Clinical studies presented this week  at the 59th Annual Scientific Meeting The American Headache Society (AHS) support the efficacy and safety of antibodies targeting calcitonin gene-related peptide (CGRP) as a preventive therapy for both episodic and chronic migraine. The new class of treatment shows convincing data that blocking the CGRP pathway prevents migraine attacks.

We’re in a genuine watershed moment with the very first class of migraine treatments that can prevent the attacks from actually happening,” said Peter Goadsby, MD, PhD, FAHS, AHS Scientific Program Committee Chair, Professor of Neurology, King’s College London and University of California, San Francisco, and Director, NIHR-Wellcome Trust King’s Clinical Research Facility, King’s College Hospital, London. “The breadth of data highlighted at the AHS Annual Scientific Meeting supports the efficacy and tolerability of CGRP-based therapies – it’s incredibly encouraging and provides much needed hope to people who continue to struggle despite a range of currently available treatments.”

CGRP monoclonal antibodies are the first mechanism-based migraine preventive treatment developed specifically for the disease. CGRP levels are known to increase during episodic and chronic migraine, and cause pain and disability. Therapeutic treatment targeting the CGRP pathway improves patients by reducing migraine days. Depending on the drug, it is delivered either intravenously or subcutaneously.

Companies presenting clinical studies of anti-GCRP therapies at the AHS 59th Annual Scientific Meeting include Alder Pharmaceuticals, Amgen and Novartis, Eli Lilly and Company and Teva Pharmaceuticals. The meeting convenes more than 1,000 migraine and headache specialists from around the world.

The AHS 59th Annual Scientific Meeting accepted more than 20 abstracts on CGRPs, including pivotal Phase 3 trial results for several compounds. The following are highlighted studies on CGRPs that will be presented live (note that presenters are subject to change):

Saturday, June 10, 2017

  • 8:30 am – 8:40 am
    Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention: Primary Results of the STRIVE Trial
    Dan Mikol, MD, PhD (ID number: IOR04)
  • 8:40 am – 8:50 am
    Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine
    Ernesto Aycardi, MD (ID number: IOR05)
  • 8:50 am – 9:00 am
    Randomized, Double-blind, Placebo-controlled Trial of ALD403 (eptinezumab), an Anti-CGRP Monoclonal Antibody for the Prevention of Chronic Migraine
    Jeffrey T. Smith, MD (ID number: IOR06)
  • 9:00 am – 9:10 am
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention
    Stewart J. Tepper, MD, FAHS (ID number: IOR07)
  • 9:50 am – 10:00 am
    Phase 3 Study (EVOLVE-2) of Galcanezumab in Episodic Migraine
    Robert Conley, MD (ID number: IOR-12LB)

Additionally, the following select CGRP studies will be presented as posters:

Friday, June 9, 2017

  • Galcanezumab Administration Was Not Associated with Increase in Blood Pressure in Patients with Osteoarthritis
    Sheena Aurora, MD (ID number: PF08)
  • ALD403 (eptinezumab) Elicits Meaningful Reductions in Migraine Activity 24 Hours After a Single Intravenous Administration
    Jeffrey Smith, MD, FCRP (ID number: PF76)
  • Fremanezumab (formerly TEV-48125) Reduces Headache Pain Within the First Week of Beginning Treatment in the Phase 2 Episodic Migraine Study
    Ernesto Aycardi, MD (ID number: PF89)

Saturday, June 10, 2017

  • Hepatic Safety of Galcanezumab in Patients with Migraine: Results of Three Phase 2 Double-blind Placebo-controlled Trials
    Vladimir Skljarevski, MD (ID number: PS05)
  • Fremanezumab (formerly TEV-48125) Decreases Migraine Symptoms Such as Nausea, Vomiting, Photophobia and Phonophobia and Reduces the Need for Acute Medications in the First Week of Treatment in the HFEM Study
    Ernesto Aycardi, MD (ID number: PS09)
  • Fremanezumab Increases the Maximum Number of Consecutive Headache Free Days for Patients with High Frequency Episodic Migraine
    Robert Noble, PhD (ID number: PS10)
  • Sustained Migraine and Headache Day Improvement with Fremanezumab (TEV-48125)
    Rashmi Halker, MD (ID number: PS11)
  • Safety and Tolerability of Galcanezumab in a Phase 2 Migraine Prevention Study
    Tina Oakes, PhD (ID number: PS19)
  • A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention: Primary Results of the ARISE Trial
    David W. Dodick, MD, FAHS (ID number: PS21)
  • Early Onset of Efficacy in a Phase 2 Clinical Trial of Erenumab in Patients with Chronic Migraine
    Stewart Tepper, MD (ID number: PS24)
  • Efficacy of Erenumab for the Treatment of Patients with Chronic Migraine in Presence of Medication Overuse
    Stewart Tepper, MD (ID number: PS32)
  • Chronic Migraine Treatment with Erenumab: Responder Rates
    Jan Brandes, MD, FAAN (ID number: PS33)
  • Phase 3 Study (EVOLVE-1) of Galcanezumab in Episodic Migraine
    Ginny Stauffer, PharmD (ID number: PS-88LB)
  • A Phase 3 Placebo-Controlled Study of Galcanezumab in Patients with Chronic Migraine: Results from the 3-month Double-Blind Treatment Phase of the REGAIN study
    Holland Detke, PhD (ID number: PS-89LB)

About Migraine
Migraine is a major disabling neurological disease that affects more than 36 million men, women and children in the United States. The disease impacts one in four households, one in five women, one in 16 men and one in 11 children in the United States. Globally, migraine is the sixth highest cause of years of life lost due to disability. Individuals who experience migraine have symptoms that include nausea, sensitivity to light and/or odors, skin sensitivity, fatigue, mood change, dizziness, difficulty concentrating, neck pain and changes in vision, including seeing spots, stars, lines, flashing lights and zigzag lines. The risk of other serious diseases is significantly higher in those with migraine, including stroke, epilepsy, depression, anxiety and chronic pain. Despite this, only one of every three people talk with a doctor about their migraine attacks and of those, only half get the right diagnosis. There is also a massive shortage of specialists focusing on migraine, with one specialist for every 65,000 individuals living with migraine, which worsens the problem.

About the American Headache Society
The American Headache Society (AHS) is a professional society of health care providers dedicated to the study and treatment of headache and face pain. The Society’s objectives are to promote the exchange of information and ideas concerning the causes and treatments of headache and related painful disorders. Educating physicians, health professionals and the public and encouraging scientific research are the primary functions of this organization. AHS activities include an annual scientific meeting, a comprehensive headache symposium, regional symposia for neurologists and family practice physicians, and publication of the journal Headache. More information can be found at www.americanheadachesociety.org. In 2010 AHS founded the American Migraine Foundation (AMF) to provide access to information and resources for individuals living with migraine, as well as their loved ones. AMF is a non-profit organization dedicated to the advancement of research and awareness surrounding migraine. Patients can learn more, find help and get connected by visiting americanmigrainefoundation.org.

CONTACT: Amra Maynard, Amra.Maynard@inventivhealth.com, +1 212 845 5625 and +1 917 302 2702