Positive results from a Phase III HALO study of fremanezumab, an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody investigational treatment for the prevention of migraine, have been announced by Israel-based Teva Pharmaceutical Industries (NYSE: TEVA).
In the chronic migraine (CM) study, patients treated with fremanezumab experienced statistically-significant reduction in the number of monthly headache days of at least moderate severity versus placebo (-2.5 days) during the 12 week period after first dose, for both monthly (-4.6 days p<0.0001) and quarterly (-4.3 days p<0.0001) dosing regimens. Similar to the Phase II trials, both patients that were on monotherapy and stable doses of prophylactic medications were included in the trial.
In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both monthly and quarterly dosing regimens, including: response rate, onset of efficacy, efficacy as monotherapy, and disability.
The results were positive, and of 13 hierarchical comparisons, p was <0.0001 in 12 of them, being 0.0004 in the remaining. The most commonly-reported adverse event in the study was injection site pain, with similar rates in the placebo and active groups.
Fremanezumab came into Teva’s drug pipeline through its 2014 acquisition of Labrys Biologicals for $200 million up front, plus up to $625 million tied to milestones.
“Migraine is a serious, debilitating neurological condition that substantially impacts all aspects of a person’s life,” said Michael Hayden, president of global R&D and chief scientific officer at Teva. “Our Phase III clinical trial program has exhibited extremely encouraging results, including with a quarterly dosing regimen, for fremanezumab in chronic migraine.
We are grateful to the patients and clinical investigators who participated in this study and helped to advance our understanding of the potential of fremanezumab as a preventive treatment option for the millions of people suffering from migraine,” Dr Hayden noted.
“These top-line results reflect our differentiated clinical development program and add to a growing body of evidence that supports the development of CGRP targeted therapy in migraine, including patients with very severe forms of the disease, with flexible dosing regimens,” added Marcelo Bigal, chief medical officer and head of specialty clinical development at Teva.
Based on these results, Teva plans to submit a Biologics License Application to the U.S. Food and Drug Administration for fremanezumab later this year. Teva’s Phase III HALO study in episodic migraine will report top-line results in the coming weeks.
Assuming final commercialization by Teva, fremanezumab will face competition from Eli Lilly’s (NYSE: LLY) anti-CGRP candidate galcanezumab, for the same indications, for which the US pharma major recently announced positive data from Phase III studies and said it expects to submit a Biologics License Application (BLA) to the US Food and Drug Administration in the second half of 2017. Also under development in this indication is erenumab by Amgen (Nasdaq: AMGN) and Novartis (NOVN: VX), with the companies having said they expect to make regulatory filings this year.
The global market for migraine treatments is forecast to reach a value of $6 billion by 2022, according to a recent report from Market Research Future, growth driven by launch of new therapies and increasing rate of drug treatment due to growing female population and rising awareness among physicians and patients.
In a research note, Evercore ISI analyst Umer Raffat said that 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.