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.
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LRP2 gene were linked with a greater relapse risk.
To identify additional genetic risk factors, researchers at KU Leuven in Belgium and colleagues conducted a genome-wide association study (GWAS) involving 506 MS patients, who had a median duration of disease of four years.
A GWAS looks for genetic variants that might serve as markers predicting the presence of a certain trait in this case, a greater rate of relapses.
Relapse was defined according to patient-reported symptoms or signs of acute inflammation due to loss of myelin in the central nervous system a hallmark of MS lasting for at least 24 hours, in the absence of fever or infection.