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Immunic, Inc. (NASDAQ:IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, announced the completion of enrollment for both phase 3 ENSURE trials of lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with relapsing multiple sclerosis and additional phase 2 CALLIPER trial data in patients with progressive multiple sclerosis underlining the recently released positive top-line results.
Additional Data Available from Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis (PMS)
Building on the recently released data showing reductions in the relative risk of 24-week confirmed disability worsening (24wCDW) events based on the Expanded Disability Status Scale (EDSS) at the end of the main treatment period, newly available data for the secondary endpoint of time to 24wCDW based on the EDSS further reinforces the neuroprotective potential of vidofludimus calcium. In the overall PMS patient population (n=467), vidofludimus calcium demonstrated a clinically meaningful reduction of the hazard ratio (HR) for 24wCDW by 24% compared to placebo (HR 0.76). Further analyses by disease subtype showed that vidofludimus calcium was associated with a 33% reduction in 24wCDW in the primary progressive multiple sclerosis (PPMS) study population (n=152) compared to placebo (HR 0.67), a 19% reduction in the non-active secondary progressive multiple sclerosis (naSPMS) study population (n=268) compared to placebo (HR 0.81), and a 34% reduction in the active secondary progressive multiple sclerosis (aSPMS) study population (n=47) compared to placebo (HR 0.66).
Similarly, consistent with the recent top-line data, further analyses of subpopulations – both with and without inflammatory gadolinium-enhanced lesion activity at baseline, who are largely shown to not benefit from current anti-inflammatory therapies – continued to demonstrate promising results. For the overall population, vidofludimus calcium reduced 24wCDW in patients without evidence of gadolinium-enhancing lesions at baseline by 34% compared to placebo (HR 0.66). Encouraging results were likewise observed for the PPMS (reduction in 24wCDW: 35%; HR 0.65) and naSPMS (reduction in 24wCDW: 30%; HR 0.70) study populations compared to placebo.
Posted In: IMUX
