Starstim Device Granted Breakthrough Designation, Natalizumab Reduces Postpartum Relapse Risk, EFRONT Dementia Study Announced

This week Neurology News Network covered the FDA decision to grant breakthrough device designation for Neuroelectrics' Starstim device, the effect of natalizumab and other DMTs on postpartum relapse risk, and the recently announced EFRONT study evaluating frontotemporal dementia.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

Neuroelectrics’ Starstim device has been granted FDA breakthrough device designation to treat refractory focal epilepsy, following pilot study results that showed a significant reduction in seizure frequency with its use. The neuromodulation platform was used to treat 20 patients with transcranial electrical stimulation. The FDA’s decision follows results from the company’s latest nonrandomized, open-label, feasibility study, which included both adult and pediatric patients (over the age of 9 years) with medically refractory focal epilepsy. Investigators found that patients experienced 44% less seizures when following up after 8 weeks of treatment with the neuromodulation platform. Additionally, relative to baseline, 4 patients saw greater than 75% reduction in seizure frequency after being treated with the Starstim device. The treatment was administered to participants over 10 sessions for a 2-week period. Evaluations were given at baseline and at the 8-week mark, as well as during the stimulation sessions. The device employs a cloud-based mechanism, allowing treatment to occur anywhere, and treatment protocols are created thanks to personalized brain models.

Natalizumab (Tysabri; Biogen) may offer an effective treatment option to minimize the risk of postpartum relapses in pregnant women with multiple sclerosis (MS) who pause treatment with disease-modifying therapy (DMT) during pregnancy, according to study findings published in Neurology. This is particularly true for those who are at low risk of progressive multifocal leukoencephalopathy, or PML. DMT reinitiation with natalizumab protected against postpartum relapse, while continuation of natalizumab use into pregnancy reduced the odds of relapse during pregnancy. Overall, reinitiation with high-efficacy DMT was independently protective against postpartum relapse and reduced the hazard of relapse by 88.9% compared to no treatment reinitiation. Additionally, those who breastfeed were also less likely to experience disease relapse.

Centogene, in partnership with Alector, has announced an observational study, named EFRONT, that will investigate the genetic mutations in patients with frontotemporal dementia (FTD). Announced in June 2021, the study anticipates genetically testing 3000 patients with FTD in Belgium, Germany, Greece, Italy, Portugal, Spain, and Turkey. Centogene’s Bio/Databank will assist in identifying candidates. As of December 2020, the company’s real-world repository has logged over 3.9 billion weighted data points from 600,000 patients in 120 different countries. Alector, a clinical-stage biotechnology company, continues to pursue immunoneurology therapies and is developing a humanized recombinant monoclonal antibody, AL001, as a potential product candidate to treat FTD.

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