Immunic announces topline data from Phase 2 EMPhASIS, IMU-838 trial
Category: #health  By Saipriya Iyer  Date: 2020-08-03
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Immunic announces topline data from Phase 2 EMPhASIS, IMU-838 trial

Immunic, Inc. has recently announced positive topline results from the Phase 2 EMPhASIS trial of IMU-838, in patients with RRMS (relapsing-remitting multiple sclerosis). IMU-838 is a next-generation, orally available selective immune modulator. It inhibits the intracellular metabolism of the activated immune cells by preventing the enzyme DHODH (dihydroorotate dehydrogenase).

MS (multiple sclerosis) is an autoimmune disease that adversely affects the optic nerve, spinal cord, and brain. In patients with MS, myelin, which protects the nerves, is damaged and attacked by the immune system. The disease mainly occurs among the adults at the prime working age. It is also 2 or 3 times more common in women as compared to men.

The trail has achieved both the primary and secondary endpoints. The primary endpoint is the statistically significant reduction in the total number of CUA (combined unique active) MRI (magnetic resonance imaging) lesions up to 24 weeks in patients that received 45mg of IMU-838 once per day by 62%, as compared to the placebo. The secondary endpoint is the significant reduction in the total number of CUA MRI lesions by 70% as compared to the placebo. Other secondary endpoints have provided a prominent numerical and signal benefit for the treatment groups.

As per the trial, the treatment-emergent adverse event rate was 42.9% as compared to 43.5% among patients on placebo. Additionally, serious adverse events were only observed in 3 out of 140 patients treated with IMU-838, and only 1 out of the 69 patients on placebo. The treatment withdrawal rate in the 24-week trial period was only 5% in the IMU-838 treatment arms as compared to 7.2% in the placebo group. Moreover, the discontinuation rates due to adverse events were equivalent between the IMU-838 treatment arms & placebo. There was also no rise in the liver or renal events.

The recent Phase 2, double-blind, randomized, placebo-controlled study also includes an extended and optional treatment period for over 9.5 years to examine the tolerability and safety of IMU-838.

Source credit:

https://www.pharmiweb.com/press-release/2020-08-02/immunic-inc-reports-positive-top-line-data-from-phase-2-emphasis-trial-of-imu-838-in-patients-with



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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