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Immunic announces vidofludimus calcium trial data

Building on the recently released data showing reductions in the relative risk of 24-week confirmed disability worsening events based on the Expanded Disability Status Scale 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, vidofludimus calcium demonstrated a clinically meaningful reduction of the hazard ratio for 24wCDW by 24% compared to placebo. Further analyses by disease subtype showed that vidofludimus calcium was associated with a 33% reduction in 24wCDW in the primary progressive multiple sclerosis study population compared to placebo, a 19% reduction in the non-active secondary progressive multiple sclerosis study population compared to placebo and a 34% reduction in the active secondary progressive multiple sclerosis study population compared to placebo. 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. Encouraging results were likewise observed for the PPMS and naSPMS study populations compared to placebo.

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