New Diagnostic Criteria Established for MOGAD, FDA Approves Proclaim XR SCS System, Clinical Hold on IKT-148009 Lifted

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Neurology News Network for the week ending February 4, 2023. [WATCH TIME: 4 minutes]

WATCH TIME: 4 minutes

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

Published in The Lancet Neurology, a convened panel of pediatric and adult neurologists, neuroimmunologists, and researchers have proposed a new diagnostic criteria for myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOGAD) that includes the presence of MOG-IgG as a core criterion. Although the availability of cell-based assays to detect serum antibodies has expanded in recent years, there have been several patients who have been previously classified as having aquaporin-4 (AQP4)-seronegative neuromyelitis optica spectrum disorder (NMOSD). While the diseases may present similarly, patients with MOGAD can have either a monophasic or relapsing course, contrary to those with multiple sclerosis (MS) or AQP4-IgG-seronegative NMOSD. The proposed criteria, which the authors noted will require validation, may have the potential to improve identification of individuals with MOGAD, thus improving the definition of long-term clinical outcomes, refining inclusion criteria for clinical trials, and identifying predictors of a relapsing vs monophasic disease course.

The FDA has approved the Proclaim XR spinal cord stimulation (SCS) system for the treatment of painful diabetic peripheral neuropathy (DPN), according to an announcement from Abbott. The company noted the system offers alternative options for those patients receiving other medications. The system was previously approved in 2019 for the treatment of chronic pain. After a minimally invasive trial and the device implantation, patients can then control their therapy via an Apple device. Abbott also noted in its announcement that individuals who receive therapy from the Proclaim XR SCS system will have access to the company’s NeuroSphere Virtual Clinic, a connected care app that allows for patient-physician communication and remote treatment adjustments via cellular or Wi-Fi connection. Notably, the list of available disease-modifying therapeutics for DPN is blank. With only symptomatic and behavioral avenues for disease management, there is great need for more treatment approaches to improve patient care.

The FDA has lifted a full clinical hold on Inhibikase Therapeutics’ phase 2 trial 201 assessing its lead product candidate IKT-148009, an Abelson Tyrosine Kinase (Abl) inhibitor for patients with Parkinson disease (PD). Those in the 50- and 100-mg groups will resume dosing immediately, with ongoing safety observations for the 200 mg group. In early December 2022, the FDA placed the hold on the company’s PD and multiple system atrophy (MSA) programs for the agent, citing several points. The agency requested further evaluation of the existing safety and pharmacokinetic (PK) data of the 200 mg dose, a better understanding of how the trial will monitor the potential for detecting adverse events (AEs) that could affect vision in trial participants, and the need for material additions to the disclosures made to investigators and patients related to the clinical and safety measures completed to that point, including the potential vision risks.

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