Teva’s novel migraine drug TEV-48125 should start phase III trials shortly, after showing ‘unprecedented’ activity in a mid-stage study, says the company.
The company is vying with rivals such as Amgen, Eli Lilly and Alder Biopharmaceuticals to bring an anti-calcitonin gene-related peptide (CGRP) targeting antibody onto the market, to provide the first completely new class of migraine drug in decades.
Migraine sufferers – and particularly those with chronic migraine defined as more than 15 headaches a month – are eagerly awaiting the results of trials of the CGRP inhibitors as they could become the first drug class to prevent attacks via a monthly subcutaneous injection.
At the moment patients must try to spot the early signs of a migraine and interrupt it with acute medications such as triptans and analgesics. Given the lack of effective preventive treatments for chronic migraine, analysts have suggested the drug which wins out in the CGRP inhibitor race could achieve sales upwards of $1.25bn a year.
The efficacy shown by TEV-48125 “has not previously been achieved at any phase in chronic migraine,” according to Teva’s chief scientific officer Michael Hayden. “Patients who have suffered from chronic migraine for many years now have a very good reason for hope,” he added.
Phase IIb trial data due to be reported at the International Headache Society in Valencia, Spain, later today reveal that two doses of TEV-48125 achieved a significant reduction in the number of headache hours after one week, with more than half of patients in each arm experiencing a 50% or greater reduction in headache frequency.
Around 15% of patients treated with TEV-48125 in the 264-subject study were totally free of headaches after three months, and a third exhibited a 75% reduction in headache frequency. Use of the drug also led to a significant reduction in on-demand migraine medications.
Meanwhile, Amgen also reported the first data from the phase II programme for its CGRP inhibitor AMG-334, showing that the drug reduced the number of migraine days in a month by 3.4 days at the highest dose tested, compared to a reduction of 2.28 days with placebo, after 12 weeks’ treatment.
AMG 334 also demonstrated a statistically significant increase in the 50% responder rate compared with placebo, with 47% of patients hitting that objective compared to 30% of the control group.
Data on another CGRP inhibitor – Alder’s ALD-403 – are also scheduled to be presented at the HIS meeting this week, while Lilly is developing another anti-CGRP antibody called tanezumab. Lilly is however focusing on episodic migraine (less than 15 headaches per month) rather than the chronic form of the condition.