Teva has unveiled data showing that its experimental migraine drug fremanezumab hit key efficacy targets in a late stage trial, on the back of which it expects to submit regulatory filings later this year.
Patients treated with both monthly and quarterly dosing regimens of the drug experienced a statistically significant reduction in the number of monthly headache days of at least moderate severity versus placebo during the 12 week period after first dose.
Results from the HALO trial showed that monthly dosing of the CGRP inhibitor was linked with a 4.6-day reduction in monthly headache days and 4.3 days for the quarterly dose compared to 2.5 days for placebo.
Also, 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, Teva said, although numbers weren’t revealed at this time.
The most commonly-reported adverse event in the study was injection site pain, with similar rates in the placebo and active groups.
Teva’s chief scientific officer Michael Hayden said the results were “extremely encouraging”, while Marcelo Bigal, chief medical officer and head of specialty clinical development, said they “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.”
The firm said it plans to submit a Biologics License Application to US regulators for fremanezumab later this year, and also that data from the HALO study in Episodic Migraine will report topline results in the coming weeks.