Immunic has drummed up some enthusiasm for its multiple sclerosis candidate, highlighting the release of previously published data in a peer-reviewed journal and sharing an update on its next trial to claw back a sliver of the value it lost after its ulcerative colitis flop.
New York-based Immunic posted the full unblinded data from a phase 2 clinical trial of its dihydroorotate dehydrogenase inhibitor vidofludimus calcium in patients with relapsing-remitting multiple sclerosis in September 2020. The peer-reviewed paper, which was published in the journal the Annals of Clinical and Translational Neurology, summarizes findings including the hit on the primary MRI lesion endpoint.
Immunic used the release of the paper to share an update on the progress of its candidate since the first data drop from the phase 2 clinical trial. Vidofludimus calcium has advanced on multiple fronts since the 2020 publication.
“Based on these strong data, we have enrolled patients in our phase 2 Calliper trial in progressive multiple sclerosis patients to further explore vidofludimus calcium’s neuroprotective potential, as exemplified by a slowing of brain atrophy and delay in disability worsening, which are often caused by axonal and neural damage,” Immunic CEO Daniel Vitt said in a statement. An interim analysis is planned for after half of the patients have completed 24 weeks of treatment.
Immunic is also running a pair of late-stage trials to evaluate the effect of vidofludimus calcium on time to first relapse in patients with relapsing multiple sclerosis. The interim analysis for the phase 3 program is slated to take place after around half of the events have happened. Immunic sees the phase 3 program providing “a straightforward path towards potential regulatory approval.”
Investors remain cool on the prospects of the company. The share price of Immunic has fallen 75% so far this year, with the last big drop coming earlier this month when vidofludimus calcium failed to move the needle in a phase 2 ulcerative colitis trial. Immunic regained some of the lost ground in premarket trading Wednesday, although even after a slight bump its share price was still down at $3.40.
The biotech ended March with $95.7 million in the bank and added $10 million to its coffers in April. The sum is forecast to see Immunic through to the third quarter of next year, by which time it should have reported data on a clutch of phase 1 programs.