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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