Benzinga - by Vandana Singh, Benzinga Editor.
Immunic Inc (NASDAQ: IMUX) announced interim data from its phase 2 CALLIPER trial of nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS).
According to a study funded by the National Multiple Sclerosis Society, nearly one million people are living with Multiple Sclerosis (MS) in the U.S.
The predefined interim analysis examined the change from baseline to 24 weeks in serum neurofilament light chain (NfL) and glial fibrillar acidic protein (GFAP) levels among approximately the first half of patients.
Serum NfL responses were consistently observed for vidofludimus calcium across progressive MS disease and all subpopulations.
In the overall PMS population at 24 weeks (N=203), vidofludimus calcium was associated with a 6.7% reduction from baseline in serum NfL, compared to a 15.8% increase over baseline in placebo (p=0.01, post hoc).
At 48 weeks (N=79), vidofludimus calcium reduced serum NfL by 10.4% from baseline, compared to a 6.4% increase in placebo.
Substantial reductions were also seen across all PMS subtypes and in patients that show or do not show disease and/or magnetic resonance imaging (MRI) activity.
Although early, interim GFAP data also showed a promising signal: at 24 weeks (N=203), GFAP increased by 3.7% for vidofludimus calcium, and 4.4% for placebo.
At 48 weeks (N=79), the change was only 2.7% for vidofludimus calcium, with a 6.4% increase for placebo.
Progression of GFAP response is generally thought to evolve more slowly than NfL, and the company believes that a longer follow-up may further strengthen this signal.
The company believes that these results corroborate separate findings from its phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis, where vidofludimus calcium was associated with a decrease in serum NfL at 24 weeks (-17.0% for 30 mg and -20.5% for 45 mg) as compared to baseline values, as contrasted with a 6.5% increase in serum NfL over baseline among placebo patients.
Price Action: IMUX shares are up 13.20% at $1.80 during the premarket session on the last check Tuesday.
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