Positive Data on Dravet Therapy STK-001, FDA Clears Zoom 88 LDP Support, MS Diagnostic Guidelines Updated

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Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Stroke Therapeutics announced new positive findings from 2 ongoing phase 1/2a studies assessing its investigational antisense oligonucleotide STK-001 in children and adults with Dravet syndrome (DS). All told, data from both the MONARCH and ADMIRAL studies and the SWALLOWTAIL open-label extension showed clinical benefit with the agent, demonstrated by reductions in convulsive seizure frequency, as well as substantial improvements in cognitive and behavior. Combining available data from 45 patients who were treated with multiple doses (30 mg, 45 mg, 70 mg) in either MONARCH or ADMIRAL, findings showed that the greatest reduction in convulsive seizure frequency was among those (n = 11) treated with 2 or 3 doses of 70 mg in the ADMIRAL study. All told, investigators observed median reductions of 80% (n = 6) and 89% (n = 3) in the multiple-ascending dose (MAD) 70 mg cohort of ADMINIRAL at 3 and 6 months postdose, respectively.

The FDA has granted 510(k) clearance to Imperative Care’s Zoom 88 Large Distal Platform (LDP) Support, a catheter-based approach to improving reperfusion in poststroke patients, further expanding the company’s complete stroke system. Zoom 88 Support is a part of the company’s Zoom Stroke Solution, which includes the existing Zoom 88 LDP and the Zoom RDL Access Platform, as well as Zoom Aspiration Catheters and Zoom POD and Pump. The newly added feature is designed to maintain the capability of 0.88” intracranial access with added stability, giving clinicians even more control over their thrombectomy procedures. The Zoom Stroke Solution is comprised of 4 vessel-matching Zoom Aspiration Catheters with a unique angled tip for enhanced clot ingestion, and the Zoom Pump with Zoom POD for sterile-field clot capture. All Zoom catheters are designed with the TRX Tip, which provides 15% greater clot engagement area at the tip of the catheter and are designed to enable smooth tracking through challenging vasculature.

Recently, the International Advisory Committee on Clinical Trials in Multiple Sclerosis published an update to its 2008 guidelines on diagnosing suspected multiple sclerosis (MS), providing additional clarity on the key clinical and paraclinical red flags clinicians should be aware of. Led by senior investigator Jeffrey A. Cohen, MD, director of Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research, the updated guidelines describe approaches to the evaluation of common MS presentations, as well as clinical and paraclinical indicators of alternative diagnoses. Although the availability of aquaporin-4-immunoglobulin (AQP4-IgG) and MOG-IgG testing has improved the ability to diagnosis AQP4-IgG-positive neuromyelitis optica spectrum disorder (NMOSD) and myelin oligodendrocyte-associated disease (MOGAD) and differentiate them from MS, comparable diagnostic biomarkers for MS remain a major unmet, the study authors noted.

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