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, GlobalData’s
managing pharma analyst Alessio Brunello noted that 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, Mr Brunello concluded.