Immunic has started discussions with Roche to include Ocrevus (ocrelizumab) in its planned Phase II/III combination study of its IMU-838 (vidofludimus calcium) in relapsing-remitting multiple sclerosis (RRMS), said CEO Daniel Vitt.
Immunic is also planning a Phase III vidofludimus monotherapy trial and is open to CRO pitches in the first half of 2020 for both studies, which are expected to be pivotal, he added.
The company is aiming for a fourth-quarter 2020 initiation for the trials if not by year-end 2020, Vitt noted. Although Immunic has strong contacts with CROs it has worked with or is working with, the company will entertain approaches from global CROs with extensive MS trial experience, he added.
The two forthcoming trials will be the centrepiece of vidofludimus’ FDA approval submission, Vitt noted. The Phase II/III combination study will investigate vidofludimus with an approved monoclonal antibody (mAb) and the other will be a Phase III monotherapy trial against generic teriflunomide, he said.
Immunic plans to conduct FDA regulatory meetings for the two trials sometime in mid-2020, and the company is in touch with key opinion leaders to flesh out trial details, he noted. While the Phase II/III combination trial is anticipated to be designed as a superiority study, the Phase III active comparison trial will likely be a noninferiority study, Vitt said. Both trials are likely to include annualized relapse rate (ARR) reductions and expanded disability status scale (EDSS) scores as efficacy endpoints, Vitt said. Each trial will likely involve over 1,000 patients and will recruit globally, he added.
In the Phase II/III combination trial, patients will likely start on a background monoclonal antibody (mAb) and then get randomized to either receive a combination with vidofludimus or placebo, Vitt said. Immunic’s first choice for the mAb is Ocrevus, he noted. Other mAbs approved for MS include Biogen’s (NASDAQ:BIIB) Tysabri (natalizumab) and Sanofi’s (EPA:SAN) Lemtrada (alemtuzumab).
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Also scheduled for next year is Immunic’s plans to publish its Phase I vidofludimus safety results in a journal, Vitt said, adding this would bolster public understanding of the therapy. The company is yet to publicly disclose detailed Phase I data.
Vidofludimus is in the195-patient Phase II EMPhASIS trial (NCT03846219), which is expected to conclude in 3Q20, Vitt said. This news service reported on 4 October that interviewed experts expected the trial to read out positive due to the drug’s highly validated MOA as a dihydroorotate dehydrogenase (DHODH) inhibitor — which it shares with teriflunomide — but the perceived higher ARR reductions with mAbs might relegate vidofludimus to a niche population.
Vitt said that the DHODH target could potentially be better suited for long-term therapy compared to mAbs due to its lower risk of progressive multifocal leukoencephalopathy. He added that no head-to-head studies have shown DHODH inhibitors as inferior to monoclonal inhibitors in ARR reduction, and certainly DHODH inhibitors are not inferior when it comes to EDSS progression.
Vidofludimus is projected to achieve sales of $1.6bn by 2030, according to an analyst report. Immunic has a market cap of $85m.
by Shuan Sim in New York
Shuan Sim is a Senior Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.