Immunic Inc (NASDAQ:IMUX) released new long-term data from an ongoing study showing that its experimental drug, vidofludimus calcium, continues to help patients with relapsing-remitting multiple sclerosis (RRMS) over time.
The biotech company said 92.3% of patients remained free of 12-week confirmed disability worsening (CDW) and 92.7% free of 24-week CDW at week 144, based on data representing roughly 952 cumulative treatment years.
“It is meaningful to see that patients treated with vidofludimus calcium during the OLE period... experienced a low rate of confirmed disability worsening,” said Dr Andreas Muehler, chief medical officer of Immunic.
“This data... further underlines our belief that vidofludimus calcium holds great potential to effectively manage the disease, help preserve neurological function, allow patients to maintain independence and improve long-term quality of life.”
Of the 29 CDW events observed through week 144, 44.8% were associated with relapse activity, while only 13.8% were linked to disease progression independent of relapse, the company said.
Vidofludimus calcium, an oral Nurr1 activator, has also demonstrated a favorable safety profile over long-term use. No new safety signals emerged over treatment durations of up to 5.5 years, and discontinuation and adverse event rates remained low.
"This new data from the OLE period is very encouraging and continues to corroborate the prior strong results we observed in our phase 2 EMPhASIS trial in RRMS," said Immunic CEO Dr Daniel Vitt. “The ability to maintain remarkably low rates of disability progression is among the most important unmet needs in relapsing MS despite the availability of multiple anti-inflammatory drugs approved for the treatment of MS relapses.”
The EMPhASIS trial, which enrolled 268 RRMS patients, initially tested three doses of vidofludimus calcium against placebo over a 24-week double-blind period. The trial met its primary and key secondary endpoints with high statistical significance and demonstrated a safety profile comparable to placebo.
Immunic said the latest findings support vidofludimus calcium’s potential to address multiple sclerosis through a combination of neuroprotective, anti-inflammatory, and anti-viral mechanisms.
“Despite 30 years of commercially available MS treatments, slowing and preventing disease progression still remains a critical unmet need,” Vitt added. “We continue to believe that vidofludimus calcium... could represent a unique new oral therapy targeted to the complex pathophysiology of MS.”
Shares of Immunic traded higher following the update, adding almost 5% in early trade.