Immunic Says Potential Inflammatory Disease Candidate Is Safe, Tolerable In Healthy Participants

Immunic Inc IMUX announced unblinded safety, tolerability, and pharmacokinetic (PK) results from Part A (single ascending doses, SAD) and Part B (multiple ascending doses, MAD) of its phase 1 trial of IMU-856 in healthy human subjects.
In the SAD part of phase 1 clinical trial, healthy human subjects were randomized to either placebo or active treatment with single ascending doses of IMU-856 at 10 mg, 20 mg, 40 mg, 80 mg, 120 mg, and 160 mg.
Single ascending doses of IMU-856 were found to be safe and well-tolerated, and no maximum tolerated dose was reached.
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No serious adverse events occurred.
Multiple ascending doses of IMU-856 were found to be safe and well-tolerated, and no maximum tolerated dose was reached. Treatment-emergent adverse events were primarily mild in severity.
The ongoing Part C of the phase 1 program is designed to assess the safety and tolerability of IMU-856 in patients with celiac disease during periods of gluten-free diet and gluten challenge.
Approximately 42 patients are planned to be enrolled in two consecutive cohorts with 80 mg or 160 mg of IMU-856 given once daily over 28 days.
Price Action: IMUX shares are down 8.05% at $3.54 on the last check Tuesday.