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Migraine Game-Changers Announce Latest Data, Research Efforts at AHS

Biohaven, Lilly, Allergan, and Alder Report Positive Findings
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The group of companies developing calcitonin gene-related peptide (CGRP) antagonists for the prevention of migraine and to treat certain types of headache released new research data at the American Headache Society’s 60th annual meeting taking place this week in San Francisco. Below is a summary. See also Practical Pain Management’s exclusive roundtable on this new medication class, featuring briefs from Amgen/Novartis, Teva, Lilly and Allergan.

First a little background: the four companies that have developed large molecule monoclonal antibody CGRP antagonists include:

  • Amgen/Novartis: erenumab-aooe (Aimovig), a receptor antagonist with a 28-day half-life; to be administered monthly at-home via subcutaneous injection; FDA approved Aimovig in May, making it the first US-approved CGRP inhibitor for adult migraine prevention
  • Alder Pharmaceuticals: eptinezumab (ALD403), a ligand antagonist with a 32-day half-life; to be administered quarterly via intravenous infusion
  • Eli Lilly: galcanezumab-gnlm (now conditionally trademarked by FDA as Emgality), a ligand antagonist with a 25- to 30-day half-life; to be administered monthly via subcutaneous injection.
  • Teva Pharmaceuticals: fremanezumab (TEV-48125), a ligand antagonist with an estimated 31- to 39-day half-life; to be administered monthly or quarterly via subcutaneous injection.

Additional gepant molecules under development include: Biohaven Pharma’s rimegepant/BHV-3000 for acute migraine and BHV-3500 for migraine prevention, and Allergan’s ubrogepant for acute migraine and atogepant for migraine prevention. These investigative products are expected to be orally administered. Below are a few company updates as reported at the American Headache Society (AHS) meeting.

Biohaven Pharmaceutical

Biohaven Pharmaceutical shared expanded data from two randomized, pivotal Phase 3 clinical trials of rimegepant that support the drug’s potential “to provide patients with pain freedom and freedom from the most bothersome migraine-associated symptom in the acute treatment of migraine using a single dose,” according to a company release.

“The two acute treatment Phase 3 clinical trials demonstrate that a single dose of rimegepant can relieve pain and restore function for people with migraine," said Richard B. Lipton, MD, chair of Biohaven’s CGRP Scientific Advisory Board.  Dr. Lipton also serves as a professor and vice chair of neurology at the Albert Einstein College of Medicine and Montefiore Health System.

In the two completed 3 trials of rimegepant, 1,162 and 1,186 patients, respectively, were randomized to receive a single dose of either rimegepant or placebo. “A full spectrum of clinically meaningful benefit compared to placebo was seen across multiple outcome measures,” including the co-primary endpoints of pain freedom and freedom from the most bothersome symptom at two hours post-dosing, stated the release. Rimegepant outperformed placebo in sustained pain freedom and sustained freedom from the most bothersome symptom from 2 to 24 hours, and from 2 to 48 hours. In terms of function, rimegepant-treated patients also reported meaningful gains over placebo in both pain relief and freedom from functional disability at 2 hours post-dose, according to the release.

Results overall demonstrated relief from migraine-associated symptoms after dosing, with a greater proportion of the rimegepant group achieving freedom from light sensitivity, sound sensitivity, and nausea over eight hours as compared to placebo. The medication was generally well tolerated, with the most frequent adverse event, nausea, occurring in only 1.4% of rimegepant patients, as compared to 1.1% of patients on placebo. Additionally, rimegepant demonstrated a liver safety profile similar to placebo; liver toxicity had previously been a concern with the small molecule migraine abortives, which are metabolized in the liver.

The company also released data from a preclinical study BHV-3500, aimed at migraine prevention, in which no active vasoconstrictive properties have been observed. This differentiates the two CGRP receptor antagonists from the current standard of care for the acute treatment of migraine (ie, triptans), which have contraindications for use by patients with cardiovascular conditions, stated the company release.

Eli Lilly and Company

Eli Lilly and Company shared positive results from its two Phase 3 studies on the effectiveness of galcanezumab-gnlm (Emgality) in patients who had previously failed treatment with Botox. Specifically, the company’s EVOLVE 1, 2 and REGAIN trials reportedly demonstrated the drug’s efficacy via two doses (120 mg and 240 mg) in patients with both episodic and chronic migraine who had previously not had relief with Botox. Subjects “experienced a statistically significant reduction in the average number of monthly migraine headache days, and at least a 50% reduction in the number of migraine headache days compared to placebo,” according to the release.

Lilly’s study of Emgality in patients with episodic cluster headache met its primary and secondary endpoints, demonstrating statistically significant differences in reduction of weekly cluster headache attacks when using the medication compared to placebo.

Finally, Lilly announced its new OVERCOME study (ObserVational Survey of the Epidemiology, tReatment and Care Of MigrainE), “which aims to be the largest study of its kind in the field of migraine, engaging 40,000 people with migraine throughout the US.” Launching off of the company’s recent Migraine Impact Report, which focused on understanding the gaps around patients living with migraine, the OVERCOME study aims to “further understand the burden of migraine and the stigma experienced by people living with migraine, identify barriers to the use of preventive and acute treatments for migraine and to assess how the introduction of novel preventive and acute treatment options may influence delivery of migraine care and costs of care in real-world settings,” according to the company’s release.

The OVERCOME study will be a two-year, multi-wave prospective, web-based patient survey that leverages learnings from the 2004 American Migraine Prevalence and Prevention Study. Conducted by Kantar Health on behalf of Eli Lilly, the study will seek to enroll two 20,000-person population samples to be followed longitudinally for two years, beginning in August 2018. Baseline data is expected in 2019, with data collection to end in 2022.

Last updated on: July 2, 2018
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