The drug met all 23 primary endpoints in its phase III trial and is expected to be submitted to the FDA by year's end.
Fremanezumab, an investigational migraine treatment, met all 25 endpoints across both monthly and quarterly dosing regimens in its Phase III study, HALO, according to results presented at the International Headache Conference (IHC) in Vancouver, Canada.
The injection, produced by Teva Pharmaceuticals, targets the calcitonin gene-related peptide (CGRP) ligand, a common migraine treatment target. The drug’s results were examined for the treatment of episodic and chronic migraine.
The HALO episodic migraine (EM) and chronic migraine (CM) phase III trials were 16 weeks, both examining 2-dose regimens — quarterly and monthly. The EM arm had 875 patients assigned either placebo (294), quarterly (291), and monthly (290) regimens, while the CM arm had 1130 patients randomized to either monthly, quarterly, or placebo (376 each).
“If you have chronic migraine, you want to bring them down to episodic, and once they are episodic, the goal is to get you to a lower frequency and prevent them from becoming chronic again,” Marcelo Bigal (pictured), MD, PhD, chief medical officer & head of specialty clinical development at Teva Pharmaceuticals, told MD Magazine. “The results, by default, need to be seen together. Having the full gamut [to treat both CM and EM] is what is important about this treatment.”
For chronic migraine, fremanezumab showed a significant reduction in monthly headache days for both monthly dosing (-4.6 days), and quarterly dosing (-4.3 days) against placebo (-2.5 days; p<0.0001) during the 12-week period after the first dose.
Similar results were seen in the reduction of weekly headache days for week 1 (-1.1 days; p<0.0001) against placebo (-0.5 days), and in the number of monthly days of acute headache medication use in both monthly (-4.2 days) and quarterly (-3.7 days) versus placebo (-1.9 days; p<0.0001).
The chronic migraine study additionally saw improvements in overall health status, as measured by the EuroQol 5-dimensions 5-response level questionnaire, as well as in overall work productivity loss, as measured by a composite of absenteeism and impairment while working.
In the episodic portion of the study, monthly migraine days during the 12-week period after the first dose were reduced by 3.7 days (monthly regimen, baseline 9.2 days) and 3.4 days (quarterly regimen, baseline 9.1 days), compared to a 2.2-day reduction with placebo (baseline 9.1 days).
Both the episodic (monthly 47.7%, quarterly 44.4%, placebo 27.9%; p<0.0001) and chronic (monthly 40.8%, quarterly 37.6%, placebo 18.1%; p<0.0001) migraine groups saw a >50% reduction in monthly average number of migraine days of least moderate severity for both dosing regimens.
The trial separated itself by focusing on the patient — roughly half of the study’s endpoints were aimed at improvement of the quality of life for those suffering from migraines. According to Bigal, the goal was to map out what mattered for the patients to see.
“The ability to be given quarterly without compromising efficacy is important,” Bigal said. “It doesn’t require infusion or IV. Patients only have to get it 4 times a year, not twice a day. This will help alleviate both patient burden and clinician burden because when done in the clinic, we can schedule visits for them every 3 months, which is their normal standard of care.”
Teva plans to move forward with the drug by submitting a new biologics license application to the US Food and Drug Administration by the end of 2017.
“We developed a clinical program for fremanezumab that was patient-centered, and closely mimicked the real-world experience of people living with the debilitating effects of migraine,” Michael Hayden, MD, PhD, the president of Global R&D and chief scientific officer at Teva, said in a statement. “We are very proud to be a leader in the development of this new type of preventive treatment for migraine which we believe holds tremendous potential to make a meaningful difference in the lives of the millions of people around the world suffering from migraine.”