Results of VISIONARY-MS Study Released, Analysis Complete for Concussion Therapy OXE103, Chronic Kidney Disease Associated With Intracerebral Hemorrhage

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CNM-Au8, an investigational treatment for relapsing multiple sclerosis (MS) consisting of a gold nanocrystal suspension, has shown positive topline results in the phase 2 VISIONARY-MS clinical trial (NCT03536559), meeting its primary and secondary end points without significant safety signals being reported.All told, on Low Contrast Letter Acuity (LCLA) measures—the primary end point—the least squares (LS) mean difference was 3.13 compared with the placebo group in the clinically affected eye over 48 weeks of treatment. Analysis of the secondary end point of mean change in modified Multiple Sclerosis Functional Composite (mMSFC) scores showed an LS mean difference of 0.28 compared with placebo. Clene noted in its announcement that the full dataset from VISIONARY-MS will be reported on at an upcoming scientific congress. ISIONARY-MS was a randomized, double-blind, placebo-controlled trial that randomly assigned patients with stable MS with a history of chronic visual impairment (who are allowed disease-modifying therapy) in a 1:1:1 fashion to CNM-Au8 in doses of 15 mg/day or 30 mg/day, or placebo.

Oxeia Biopharmaceuticals has announced that it has completed an interim analysis of its ongoing phase 2 trial of the investigational therapy OXE103, a potential pharmaceutical treatment for concussion.1 No specific data were released in this announcement, but the company noted that once the full topline dataset is available, the results will be presented at an upcoming medical conference. The trial is being conducted at the University of Kansas Medical Center and is seeking to enroll 40 participants within 28 days of concussive injury who are highly symptomatic at screening, with a primary outcome measure of symptom management changes as measured by the Post Concussion Symptoms Scalequestionnaire during the intervention period, done at days 1 and 15, and the post-treatment period, done at days 21 and 44. Secondary outcomes include the Quality of Life after Brain Injury–Overall Scale questionnaire and the Patient Global Assessment Scale, and Oxiea noted that measures of cognition and balance will also be tracked to provide objective assessment of recovery. The study is 2-part in nature: part A, consisting of the postacute phase—within 28 days of injury—which does not include randomization but will feature an option for patients to forego treatment and enter the control group; and part B, consisting of the acute phase—within 24 hours of injury—that will include double-blind randomization to either OXE103 or placebo.

According to a data from a 3-stage study that combined epidemiologic and genetic analyses, chronic kidney disease (CKD) was independently associated with a higher risk of intracerebral hemorrhage (ICH), regardless of race or ethnicity. In addition, CKD was associated with poor functional outcome following ICH. The first of the studies, titled ERICH, included 2914 participants with ICH and 2954 controls, with a similar mix of races and ethnicities across the cohort. CKD, present in 4.3% of ICH cases vs 1.3% of controls, was associated with an increased odds of ICH in unadjusted and adjusted analyses. In patients with CKD, the risk of ICH was not modified by race and ethnicity or hemorrhage location. Senior author Guido Falcone, MD, ScD, MPH, assistant professor of neurology, Yale School of Medicine, and colleagues concluded, "Future research is needed to elucidate the biologic mechanisms responsible for the associations of CKD with the risk and severity of ICH and to study the genetic associations reported here in Asian, Black, and Hispanic or Latino populations.”

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