Immunic, Inc. announced the outcome of a pre-planned interim group-level data analysis of its phase 1b clinical trial of IMU-935 in patients with moderate-to-severe psoriasis. The overall trial is ongoing and remains blinded. The pre-planned interim analysis revealed that the group averages for Psoriasis Area and Severity Index (PASI) reductions in the two active arms did not separate from placebo at four weeks.

Although the active arms performed in line with prior expectations, the trial experienced a greater decrease than expected in PASI in the placebo arm based on similarly designed trials. The trial, conducted in Australia, New Zealand and Bulgaria, was structured as a 28-day, double-blind, placebo-controlled trial. A total of 41 patients were enrolled and the trial evaluated IMU-935 at doses of 150 mg once-daily and 150 mg twice-daily versus placebo (randomized 3:1).

The primary objective was the evaluation of the safety and tolerability of IMU-935 in moderate-to-severe psoriasis patients. At this point, the company only has access to very limited information. The interim analysis only revealed mean values at group-level up to the end of the four-week treatment period.

Immunic does not yet have access to unblinded individual patient data. Moreover, pharmacodynamic, biomarker – including skin punches and IL-17 levels in serum – or pharmacokinetic data, at either an individual or group-level, are not yet available. Based on the already available preclinical and clinical safety and tolerability data, Immunic has the flexibility to consider additional higher-dose or longer treatment cohorts.

Supported by the broad availability of activity data from in vitro and in vivo studies in various disease models and settings, the company continues to believe in IMU-935's potential therapeutic activity. Finally, although the safety data remains blinded, administration of IMU-935 and placebo in this trial were demonstrated to be safe and well-tolerated, and no new safety signals were observed. The company reiterates its prior guidance that current cash, cash equivalents and marketable securities are expected to fund operating and capital expenditures into the fourth quarter of 2024.

Regarding the company's upcoming clinical milestones, as previously announced, data from the interim analysis of the phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis are expected to be available in the second half of 2023 and top-line data at the end of 2024. Moreover, the read-out of the first of the phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis is targeted for end of 2025. Finally, initial clinical efficacy data of the Part C portion of the ongoing phase 1 clinical trial of IMU-856 in celiac disease patients are expected in 2023.