Vormatrigine Reduces Seizures in Phase 2 RADIANT Study, Postpartum Depression in MS Women, Ianalumab Produces Significant Phase 3 Data in Sjögren’s disease

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

Recently announced findings from the phase 2 RADIANT study (NCT06908356) showed that treatment with Praxis’ vormatrigine, a functionally selective small molecule, led to significant attenuation of seizures among those with focal onset seizures. Additional data from the study is expected to be presented at the upcoming International Epilepsy Congress (IEC), taking place August 31, in Lisbon, Portugal. The open-label trial featured patients with focal onset or primary generalized tonic-clonic seizures concurrently taking at least 1, but no more than 3 acceptable anti-seizure medications prior to entering. Over the 8-week treatment period, treatment with 30 mg/day of vormatrigine led to a 56.3% median reduction in seizure frequency, with 54% of patients achieving at least a 50% response in the first week.

A recently presented clinical study of women with multiple sclerosis (WwMS) identified some potential links to postpartum depression (PPD), as well as found an overall higher rate of PPD than reports in both general and MS populations. All told, these data underscored the importance of screening for PPD from late gestation until 12 months postpartum, while also suggesting that active management of MS inflammatory activity could reduce PPD burden. Part of a late-breaking abstract at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, the study featured 121 WwMS enrolled across 2 sites starting at gestational week 36 and followed serially until 12 months postpartum. At the conclusion of the study, PPD by any measure was associated with Black/Hispanic ancestry (OR, 1.24; 95% CI, 0.09-2.40; P = .03), pre-pregnancy depression/anxiety (OR, 2.15; 95% CI, 1.12-2.91; P = .000), and absence of exclusive breastfeeding (OR, 3.28; 95% CI, 0.19-2.18; P = .01).

New positive topline data from the phase 3 NEPTUNUS-1 (NCT05350072) and NEPTUNUS-2 trials (NCT05349214) revealed that investigational ianalumab (Novartis) was safe, met primary end point, and resulted in a statistically significant reduction in disease activity for Sjögren’s disease. According to the company, these data support the therapeutic potential and mechanism of ianalumab, a B-cell depleting agent with BAFF-R inhibition, as the first targeted treatment for Sjögren’s disease. The trials, which aim to assess safety and efficacy of ianalumab, differed slightly in design. NEPTUNUS-1, a randomized, double-blind, 2-arm trial, comprised 275 patients testing 300 mg of subcutaneous ianalumab vs placebo for a 52-week period. NEPTUNUS-2, also a randomized, double-blind study, included 504 patients testing 3 arms of either ianalumab 300 mg SC monthly or every 3 months compared with placebo for a 52-week period.

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