Immunic: Pre-Planned Phase 1b Interim Analysis of IMU-935 in Psoriasis Confounded by High Placebo Rate

 – Interim Analysis Revealed Unexpected High Placebo Rate; Two Active Arms Did Not Separate From Placebo –

– No New Safety Signals Observed for IMU-935 in this Trial –

– Company Expects to Continue IMU-935 Development in Psoriasis –

 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today 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.

https://finance.yahoo.com/news/immunic-reports-pre-planned-phase-200100724.html