Strong clinical data with single dose rimegepant in acute treatment of migraine announced by Biohaven

– Broad and clinically important benefits beyond the initial registrational endpoints are now reported.

– Durability of clinical effect was seen across multiple outcome measures and findings were consistent across both pivotal Phase 3 trials.

– A single dose of rimegepant, without any rescue medications, was superior to placebo for pain freedom and pain relief at 2 hours post-dosing, and showed a profile of increasing improvement throughout the first eight hours that was sustained compared to placebo out to 24 and 48 hours.

– The vast majority of rimegepant treated patients did not take rescue medications during the 24 hour period after dosing.

– Rimegepant-treated patients showed improvement on measures of functional disability with a greater proportion of patients achieving normal function.

– Rimegepant demonstrated a safety profile similar to placebo including liver function tests.

– Tolerability profile with rimegepant was similar to placebo and favorable compared to historical triptan experience.

– More than 3x the number of subjects who responded to treatment preferred rimegepant over their previous therapy.

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced the results of key secondary outcome measures from Phase 3 clinical trials (BHV3000-301 and BHV3000-302) of rimegepant, the first oral CGRP receptor antagonist to deliver positive data on pain freedom and most bothersome symptom in two pivotal Phase 3 trials in acute treatment of migraine. As previously reported, rimegepant met the co-primary efficacy endpoints with significant superiority to placebo, at two hours post-dose, on pain freedom and freedom from the most bothersome symptom (MBS); endpoints which, according to FDA guidance, are needed for registrational filing. These clinical trials showed an early separation from placebo and a profile of continued improvement after a single dose of rimegepant in patients who did not take any rescue medications.

A durable effect with rimegepant was achieved with pain freedom lasting up to 48 hours following a single dose. The percent of patients experiencing pain freedom between 0 to 8 hours after dosing is depicted in the Kaplan-Meier curves in Figure 1. The percent of patients experiencing sustained pain freedom from 2 to 24 hours and through 2 to 48 hours is shown in the accompanying table. Increasing benefit is evident from 2 to 4 hours with durability of these effects lasting through 48 hours.

Figure 1:Durable Treatment Effects on Pain Freedom¹

Approximately 90% of patients who took rimegepant and no rescue medications achieved the clinically important endpoint of pain relief within 8 hours, which signifies an important return to daily function (Figure 2). Onset of pain relief was observed early with numerical separation evident approximately 30-45 minutes post-dosing. By 90 minutes statistical significance was achieved in both studies. Pain relief was sustained throughout 48 hours (Figure 2). The sustained pain relief profile was similar to that observed for sustained pain freedom.

Figure 2:Durable Treatment Effects on Pain Relief²

Pain relief is associated with reduced disability and function as shown in these studies (Figure 3). Rimegepant-treated patients showed improvement on functional disability at 2 hours post-dosing in both pivotal trals. This outcome is clinically important because it indicates the patient’s recovery and ability to resume daily activities.

Figure 3:Freedom from Functional Disability (Patients Achieving Normal Function)³

Vlad Coric, M.D., Chief Executive Officer of Biohaven, commented, “We are proud to be the first to deliver a positive dataset from two Phase 3 pivotal trials meeting current FDA guidance that shows robust and durable clinical benefit from a single dose of an oral CGRP receptor antagonist in the acute treatment of migraine. The strength of these data are highlighted by rimegepant showing benefits over placebo in 11 out of 13 prespecified primary and secondary outcome measures in both trials. Our observations in both trials of comprehensive and durable efficacy, a favorable safety and tolerability profile, and the ease of oral dosing, together represent an attractive profile to submit to regulatory authorities with the goal of ultimately bringing relief to patients suffering from migraine.”

Richard B. Lipton, M.D., Vice Chair of Neurology, Professor of Epidemiology and Population Health and Director of the Montefiore Headache Center, at the Albert Einstein College of Medicine, and Chair of Biohaven’s CGRP Scientific Advisory Board added, “The single dose data from these two clinical trials are very exciting as rimegepant brings forward a novel mechanism of action that has demonstrated important clinical benefit to patients. Most of the patients I see with migraine are actively working and raising children, and relieving pain and restoring function means they can once again take care of their families and return to work. The new data reviewed today encourages me that rimegepant, if approved, can meet their needs for an acute treatment with lasting clinical benefit.”

Over 36 million Americans suffer from migraine. Acute attacks of migraine can differ in intensity and frequency, with many being highly disabling. More than 90% of migraine sufferers are unable to work or function normally during an attack. CGRP receptor antagonists represent a novel class of drug candidates for the treatment of migraine and are the first new class specific to the acute treatment of migraine in over 25 years. This unique and specific mode of action potentially offers an alternative to current agents, particularly for those who have contraindications to the use of triptans, such as patients with underlying cardiovascular diseases, or for patients who do not respond to triptans.

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News Source: Biohaven Website

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