Immunic Sets Optimal Dose of Oral IMU-838 for Phase 3 Trials in RRMS 4.8 (5)
Interim data from a Phase 2 trial of Immunic Therapeutics’ investigational oral therapy IMU-838 (vidofludimus calcium) in relapsing-remitting multiple sclerosis (RRMS) patients has established a once-daily, 30 mg dose as the most appropriate for future Phase 3 trials.
The company is now in discussions with regulatory authorities, including those in the U.S. and Europe, regarding pivotal Phase 3 testing expected to start later this year.
At the request of the U.S. Food and Drug Administration (FDA), Immunic will directly submit an investigational new drug (IND) application for the right to open a Phase 3 trial, instead of waiting for an end-of-Phase 2 meeting, it reported in a press release.
Harvard Professor Wins Dystel Prize for Work on MS Immune Mechanisms
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Ocrevus Use Linked to PML in Man, 78, With PPMS, Case Report Says
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