Immunic Gets FDA Clearance for IND Application for Multiple Sclerosis Treatment
July 01 2021 - 8:45AM
Dow Jones News
By Chris Wack
Immunic Inc. said it received U.S. Food and Drug Administration
clearance of its investigational new drug application for the Phase
3 program of lead asset IMU-838.
IMU-838 is a selective oral DHODH inhibitor in patients with
relapsing-remitting multiple sclerosis, the biopharmaceutical
company said.
The FDA also cleared the company's separate investigational new
drug application for the supportive Phase 2 trial of IMU-838 in
patients with progressive multiple sclerosis.
The Phase 3 trials were designed to evaluate the efficacy,
safety, and tolerability of IMU-838 versus placebo in
relapsing-remitting multiple sclerosis patients. Immunic said it
believes that the Phase 3 program provides a path towards potential
regulatory approval of IMU-838 in relapsing-remitting multiple
sclerosis.
The next identical twin Phase 3 trials are expected to enroll
1,050 adult patients with active relapsing-remitting multiple
sclerosis at more than 100 sites in 14 countries. Key secondary
endpoints include volume of new T2-lesions, time to confirmed
disability progression, time to sustained clinically relevant
changes in cognition, and percentage of whole brain volume change,
grey matter volume, and white matter volume.
Immunic shares were up 5% to $12.80 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 01, 2021 08:32 ET (12:32 GMT)
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