By Jasmine Li
Shares of Immunic rose after the biopharmaceutical company reported a positive outcome in its interim analysis of a treatment for relapsing multiple sclerosis.
The New York-based company's stock price climbed 12% to $1.74 in premarket trading. Shares had reached a 52-week high of $2.11 last month.
The oral treatment, vidofludimus calcium (IMU-838), had a positive outcome in the non-binding, interim futility analysis of its Phase 3 ENSURE program, Immunic said. An unblinded Independent Data Monitoring Committee recommended that the trials should continue as planned.
"The ongoing ENSURE program comprises two identical multicenter, randomized, double-blind Phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients," Immunic said.
Chief Executive Officer Daniel Vitt said the Phase 3 program provides a clear and straightforward path toward seeking potential regulatory approval. The trials, which are expected to enroll about 2,100 adult patients with active RMS, are on track to be completed in 2026.
"Our next clinical milestone for vidofludimus calcium is the top-line readout of our Phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS), which we expect to release in April of next year," Vitt said.
Write to Jasmine Li at jasmine.li@wsj.com
(END) Dow Jones Newswires
October 22, 2024 09:07 ET (13:07 GMT)
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