An experimental Teva Pharmaceutical migraine drug has met the main goals of a late-stage clinical trial, keeping the drugmaker in the race to bring to the market a product that prevents migraine headaches instead of treating them after they start.
Teva (NYSE: TEVA) reported Wednesday that its drug fremanezumab reduced the number of days during which chronic migraine patients experienced moderate to severe headaches in a Phase 3 clinical trial. Based on those early results, Israel-based Teva, which operates a U.S. headquarters in North Wales, PA, says that it plans to file for FDA approval later this year.
More than 38 million people in the U.S. experience migraines, according to the Migraine Research Foundation. Worldwide, the condition affects more than 1 billion people. The injectible Teva drug is part of a new class of drugs that work by blocking a protein, calcitonin gene-related peptide (CGRP). Released by neurons, this protein is thought to have a role in the transmission of pain. Unlike triptans, the now-generic class of drugs that have become the standard migraines treatment, CGRP inhibitors aim to prevent migraine headaches from starting.
Teva’s Phase 3 clinical trial enrolled 1,130 patients who were randomly split into three groups. The group testing monthly dosing received an initial 675 mg injection when the trial started, which was followed by monthly 225 mg doses for two months. A second group testing quarterly dosing of the drug also started at 675 mg, followed by placebo for two months. The third group received three monthly doses of placebo. The main goal of the study was to measure a mean change in the monthly average number of days patients said they had headaches. The Migraine Trust defines chronic migraine as more than 15 headache days per month.
During the three month study, Teva said that patients who received its drug had 2.5 fewer days of moderate to severe migraine headaches per month compared to those who received a placebo after the initial dose. While that might seem like a small number, it’s enough to count as statistically significant, the company says. The most common side effect reported was pain at the site of the injection.
Those results come two weeks after Indianapolis-based Eli Lilly (NYSE: LLY) reported positive results for its CGRP inhibitor, galcanezumab. Both Lilly and Teva trail Amgen (NASDAQ: AMGN), which is readying its application for FDA approval after reporting positive results for its drug from two Phase 3 trials last year. Other companies in the CGRP migraine drug race include Bothell, WA-based Alder Biopharmaceuticals (NASDAQ: ALDR) and Allergan (NYSE: AGN).
Many analysts expect Amgen will be the first company to bring a CGRP inhibitor to the market. But if Teva’s drug is approved, it might have a dosing advantage. In a research note, Evercore ISI analyst Umer Raffat wrote Teva’s most important data point is the success in the quarterly dosing group. Neither Amgen nor Lilly have developed their migraine drugs for quarterly dosing, and if the drugs work comparably well, the ability to offer patients fewer needle sticks could be a competitive advantage, he said.
Teva brought fremanezumab into its drug pipeline through its 2014 acquisition of San Mateo, CA-based Labrys Biologics for $200 million up front, plus up to $625 million tied to milestones. The Teva drug is now starting to hit those milestones. The company says it will report in coming weeks initial results from a Phase 3 trial testing the drug as a treatment for episodic migraine.