Zilucoplan for Mysathenia Gravis, AXS-05 for Agitation in Alzheimer, and Chronic Migraine Management

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Neurology News Network for the week of December 15, 2018.

This week, Neurology News Network covered the positive top-line results from a phase 2 clinical trial evaluating zilucoplan for treatment of generalized myasthenia gravis, the interim analysis reporting positive outcomes from Axsome Therapeutic's phase 2/3 trial of AXS-05, an investigational agent for agitation associated with Alzheimer disease. Additionally, we spoke about NeurologyLive's newest Peer Exchange, "Chronic Migraine New Paradigms in Management," which provides peer-to-peer dialogue from several migraine experts. (Transcript below.)

Matt:

Welcome to Neurology News Network. I’m Matt Hoffman.

Jenna:

And I’m Jenna Payesko. Let’s get into the news from this week.

Zilucoplan has shown positive top-line results in a phase 2 clinical trial evaluating the therapy for the treatment of generalized myasthenia gravis, according to manufacturer Ra Pharmaceuticals. Compared to placebo at 12 weeks, the 0.3 mg/kg dose of the therapy achieved a mean reduction from baseline of 6 points in QMG score and 3.4 points in the MG-ADL score.

Additionally, no patients required rescue therapy when treated with the 0.3 mg/kg dose of zilucoplan. Comparatively, rescue therapy of intravenous immunoglobulin or plasma exchange was necessary for 20% of those in the placebo arm, and 7% in the 0.1 mg/kg arm.

Matt:

Positive outcomes have been reported in Axsome Therapeutic’s interim analysis of its phase 2/3 trial of AXS-05, the company’s investigational agent for agitation associated with Alzheimer disease. After an IDMC conducted its unblinded, prespecified interim analysis for the futility of the ADVANCE-1 trial, it found that the therapy has shown enough to continue the exploration of its safety and efficacy.

This first interim analysis was performed on approximately 30% of the target number of subjects to assess futility. The second interim analysis is anticipated by Axsome to be performed on approximately 60% of the target number of subjects to assess efficacy.

Jenna:

This week, NeurologyLive’s newest Peer Exchange, titled “Chronic Migraine New Paradigms in Management,” has premiered! Featuring migraine experts such as Stephen D. Silberstein, Peter Goadsby, Stewart Tepper, Jessica Ailani, and David Dodick, the series will provide peer-to-peer dialogue and their authoritative insights, opinions, and perspectives on important issues facing today’s healthcare professionals treating chronic migraine.

Let’s take a look.

Matt:

For more direct access to expert insight, head to neurologylive.com. This has been Neurology News Network. Thanks for watching.

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