IMU-838 could be alternative treatment option for RRMS patients who are ineligible with mAbs, says GlobalData

Following the publication of positive top-line data from the Phase II EMPhASIS trial of IMU-838 (vidofludimus calcium) in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) by Immunic;

Alessio Brunello, Managing Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:

“Patients who are ineligible for treatments with monoclonal antibodies (mAbs) might benefit from treatment with IMU-838, if it proves to be safer than Aubagio (teriflunomide) in the planned Phase III trial. IMU-838 is a dihydroorotate dehydrogenase (DHODH) inhibitor with the same mechanism of action (MOA) of Aubagio (teriflunomide), which, while it is seeing modest success in the treatment of MS, is currently not being used as a first line therapy due to its modest efficacy and safety concerns.

“However, it is unlikely that any patients that are already stable on existing mAb treatment would want to switch to what might be perceived as a less efficacious medicine, as DHODH inhibitors are used later in the treatment algorithm for MS. Even though, the Phase II trial showed positive data in terms of efficacy and safety, it is unclear how much safer IMU-838 will be over Aubagio as the trial EMPhASIS was not a head-to-head study, and it could be explored more in another clinical trial.

“IMU-838 has a convenient oral route of administration and the positive clinical trial results from the Phase II might give to this drug a slight market potential in RRMS; however, Aubagio has shown already its modest efficacy and safety concerns that limited its market share”.

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