Welcome to this special edition of Neurology News Network. I'm Marco Meglio.
In recent news, Bright Mind Biosciences announced positive topline results from its phase 2 BREAKTHROUGH trial (NCT06401538) assessing investigational BMB-101, a selective 5-HT2C biased agonist, in adults with drug-resistant absence seizures and developmental and epileptic encephalopathies (DEEs). Based on the positive data, which included BMB-101 meeting primary end point, the company is planning a global, registrational trial to further validate the agent’s efficacy and safety. The trial data featured 24 patients, 15 of whom had absence seizures and 9 who had DEEs. In the absence cohort (n = 11), investigators recorded a 73.1% median reduction in the number of absence seizures for at least 3 seconds (P = .012), and a 74.4% median reduction in total time in seizures lasting at least 3 seconds during the 24 hours (P = .012). Above all the drug was considered well-tolerated, and patients achieved robust reduction of absence seizures regardless of seizure duration.
A prospective, interventional, open-label, pilot cohort study (PMC12638507) evaluated the effectiveness of liraglutide (Victoza; Novo) as an add-on treatment of high-frequency or chronic migraine in patients with obesity, with data that showed a significant reduction in headache frequency. Investigators concluded that while more studies are needed to confirm these observations, the findings suggest that impaired increased intracranial pressure (ICP) regulation may contribute to migraine pathogenesis and represent a potential therapeutic target. Results from the pilot cohort demonstrated a significant reduction in mean monthly headache days, decreasing from 19.8 (SD, 6.7) at baseline to 10.7 (SD, 7.7) days following treatment. This represented a mean reduction of 9.1 days (95% confidence interval [CI], 5.41–12.84; P < 0.001; Cohen’s d = 0.90). Analysis of covariance showed that age, sex, and concomitant medications did not significantly influence the reduction in headache frequency (all P > 0.05).
According to a new announcement, the FDA has approved ScinoPharm Taiwan’s glatiramer acetate (GA) injection as a treatment for relapsing multiple sclerosis (MS), making it the first complex injectable generic approval for this therapy. GA, originally marketed as Copaxone in 1996, has been recognized as one of the most challenging complex synthetic polypeptides globally. This newly approved version is a non-biological complex drug (NBCD) generic, meaning it has the same active, route, and typical strengths of traditional GA, mirroring the Copaxone label. While Scino’s new GA formulation has the same active ingredient, indications, and route/dosing as Copaxone, some of the key differences are with the manufacturer and process. For context, ScinoPharm noted it uses its own proprietary synthesis and purification process for the GA polymer, further stressing their capabilities in complex peptide manufacture and stringent quality control.
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