Immunic Touts Favorable Phase II Results for MS Treatment

Immunic has released favorable updated results for the Phase II EMPhASIS clinical trial investigating the safety and efficacy of vidofludimus calcium (IMU-838), with an indication to treat relapsing-remitting multiple sclerosis (RRMS). The new analysis was published today in Annals of Clinical and Translational Neurology, building details published after the 2020 study conclusion.

Vidofludimus calcium is considered to be a best-in-class dihydroorotate dehydrogenase (DHODH) inhibitor capable of preventing brain lesions from forming, a key indicator of RRMS progression. 

Notably, the study met its primary endpoint measurement as well as meeting the most critical secondary endpoints, according to the 2020 analysis. The primary endpoint evaluated whether the participants receiving vidofludimus demonstrated a statistically significant reduction in the total number of combined unique active MRI lesions, in comparison to the placebo control group. The analysis showed that, at week 24, participants achieved an impressive 62% reduction in lesions. 

In support of the original findings, the analysis published Wednesday shows more encouraging anti-inflammatory effects at a 30 mg dose than at a 10 mg dose. The anti-inflammatory effects were measured using contrasted MRI scans of lesions. Patients given the higher dose benefited with a 78% reduction in the presence of lesions, compared to those given the lower dose that showed a lesser 13% reduction. This information will go on to influence the dosing schedule of participants in the upcoming Phase III trial for vidofludimus calcium in patients with RRMS.

"The publication of the EMPhASIS trial results in a peer-reviewed journal is a testament to the importance of our Phase II findings for vidofludimus calcium in patients with RRMS," Daniel Vitt, Ph.D., Immunic CEO and president, said in a statement. 

"Based on these strong data, we have enrolled patients in our Phase II 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. Equally exciting, we have also been enrolling patients in our Phase III ENSURE program of vidofludimus calcium as a treatment for relapsing multiple sclerosis (RMS). We remain highly enthusiastic about the potential for this novel therapeutic to become a best-in-class DHODH inhibitor in RMS," Vitt added.

As Vidofludimus calcium enters a Phase III clinical setting, it is also being evaluated in a separate Phase II study. The late-stage ENSURE trial began enrollment in late 2021. Given the candidate’s success, regulatory filings are anticipated to occur soon. 

Immunic’s other candidates are in earlier phases of development. Phase II CALDOSE-1 trial top-line data was shared earlier this month, showing a failure to meet the primary endpoint of clinical remission in patients dosed in comparison to the placebo group.

This trial evaluated the safety and efficacy of vidofludimus calcium indicated as a treatment for ulcerative colitis. In addition to the primary endpoint failure, no significant differences were seen between the three different dosing arms. Given these results, Immunic may not continue to pursue vidofludimus calcium for this indication without a co-developer.

Additional data is anticipated later this year for the ongoing Phase I study investigating IMU-856 in celiac disease patients. The study began last month, in May, and represents the first time humans receive the orally-dosed small molecule inhibitor. If successful, the treatment will restore functionality to the intestinal barrier as well as regenerate the patient bowel epithelium.

Another candidate, IMU-935, is being evaluated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), psoriasis and Guillain-Barré syndrome. With an indication for moderate-to-severe psoriasis, a Phase I trial is underway. Earlier data was shared regarding the positive pharmacokinetic and pharmacodynamic results for healthy patients of the IMU-935 trial, and the second arm has begun. This second arm moves from the evaluation of healthy patients to patients that have been diagnosed with psoriasis.