The objectives of this clinical trial are to assess safety, tolerability, and pharmacokinetics of IMU-935. This is a first-in-human, double-blind, randomized, placebo-controlled clinical trial comprising three parts. In part A, healthy volunteers in cohorts of 8 subjects each were enrolled and received single ascending doses of IMU-935 (25 to 400 mg) or placebo (ratio 3:1). In part B, healthy volunteers will receive multiple ascending doses of IMU-935 or placebo for 14 days, and in part C, patients with moderate to severe plaque-type psoriasis will take either two different dose levels of IMU-935 or placebo. First clinical experience with IMU-935 comes from part A of this clinical trial which has recently been completed. Pharmacokinetic evaluation showed the half-life of IMU-935 ranging from 16.5 to 31.0 hours and strict dose proportional increases of Cmax and area under the plasma concentration-time curve (AUC). Treatment-emergent adverse events (TEAEs) related to study drug administration were reported in 29 of 71 (41 %) subjects, with a total of 50 drug-related TEAEs. Most related TEAEs were mild in severity (48 TEAEs), two were moderate. Across all cohorts, related TEAEs occurring in more than 2 subjects were diarrhoea (6), headache (6), abdominal distension (4), gastroesophageal reflux (4), constipation (3), and nausea (3). Overall, the number or severity of adverse events did not increase with ascending doses. There were no serious adverse events or adverse events that led to study discontinuation. There were no other clinically meaningful findings relative to safety and tolerability, as assessed by physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs). IMU-935 has linear pharmacokinetics after single oral doses that allow for once daily dosing. IMU-935 is safe and well tolerated with a benign adverse event profile up to 400 mg as a single dose. Ongoing recruitment will provide intitial data on the anti-psoriasis activity of IMU-935.

ESDR057 - First clinical experience with IMU-935, an orally available small molecule inhibitor of IL-17

50th Annual Meeting of the European Society for Dermatological Research. VIRTUAL MEETING