Immunic, Inc. (IMUX), a biotechnology company developing orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, announced Tuesday new, positive long-term open-label extension or OLE data from Phase 2 EMPhASIS trial of vidofludimus calcium (IMU-838) in relapsing-remitting multiple sclerosis or RRMS.
In the pre-market activity on the Nasdaq, Immunic shares were gaining around 3 percent.
The company's lead asset, vidofludimus calcium, is an orally administered investigational small molecule drug being developed for chronic inflammatory and autoimmune diseases. It is currently in late-stage clinical trials for multiple sclerosis.
The phase 2 EMPhASIS trial was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group study, designed to assess the efficacy and safety of vidofludimus calcium in patients with RRMS.
The company noted that the data at week 144 showed that 92.3% of patients remained free of 12-week Confirmed Disability Worsening or CDW, and 92.7% free of 24-week CDW.
A total of 29 CDW events were confirmed at 12 weeks following the trigger event through week 144. Of these, 44.8% were associated with relapse-associated worsening, while only 13.8% were associated with progression independent of relapse activity.
Andreas Muehler, Chief Medical Officer of Immunic, said, "It is meaningful to see that patients treated with vidofludimus calcium during the OLE period of our phase 2 EMPhASIS trial in RRMS experienced a low rate of confirmed disability worsening (CDW) events, as measured by the Expanded Disability Status Scale (EDSS). This data, representing approximately 952 treatment years, 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."
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