IND Cleared for Cell Therapy in Progressive MS, FDA Approves IPX203, Migraine Treatment Nerivio Safe in Pediatric Populations

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

According to a new announcement, the FDA has cleared the investigational new drug (IND) application for Indapta Therapeutics’ g-natural killer (g-NK) cell therapy IDP-023 to be assessed in a phase 1 clinical trial for the treatment of patients living with progressive multiple sclerosis. In the trial, investigators from Stanford University and the University of California, San Francisco (UCSF), will examine the biologic effects of IDP-023 using a translational program developed in collaboration by both universities. During the study, the participants with progressive MS will be given IDP-023 in combination with the FDA approved anti-CD20 monoclonal antibody, ocrelizumab. For context, ocrelizumab remains the only approved therapy for the treatment of progressive MS.

The FDA has approved Amneal Pharmaceuticals’ investigational agent IPX203, an oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules, as a treatment for patients with Parkinson disease (PD), according to an announcement from the company. Marketed as Crexont, the therapy is an oral formulation CD/LD which includes immediate-release (IR) granules as well as extended-release (ER) pellets. The treatment is indicated for PD, PD caused by infection or inflammation of the brain, or PD-like symptoms that may result from carbon monoxide or manganese poisoning in adults. It is not recommended in combination with nonselective monoamine oxidase inhibitors, nor with other CD/LD preparations without consultation with a healthcare provider. Amneal noted its expectation is for the oral formulation to become available to patients in the United States in September 2024.

A recently published study (NCT06138756) of children ages 6-11 years showed that treatment with Theranica’s Nerivio remote electrical neuromodulation (REN) wearable device was safe and effective as an acute migraine treatment in this age population. Based on these data, providers and families seeking an effective, alternative, pill- and needle-free option for children dealing with migraine may consider REN. Nerivio, a non-drug option for both acute migraine attacks and prevention of migraine with or without aura, has been FDA-approved for several years in adolescents and adults aged 12 and older. It currently remains under FDA review to possibly expand its indication to include those aged 8 years and older. To date, the treatment landscape acute migraine in children aged 6-12 is extremely limited, as rizatriptan is the only cleared pharmacologic treatment available in this age group.

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