Business
Immunic, Inc. Publishes Positive Results from the Single and Multiple Ascending Dose Parts of its Phase 1 Clinical Trial of IMU-935, a Potentially Best-in-Class Oral IL-17 Inhibitor
- Unblinded Data Established a Favorable Safety and Tolerability Profile for IMU-935 in Single Dose and 14-Day Multiple Dose Assessments in Healthy Human
About this update from Immunic, Inc.
[{"type":"text","content":"- Unblinded Data Established a Favorable Safety and Tolerability Profile for IMU-935 in Single Dose and 14-Day Multiple Dose Assessments in Healthy Human Subjects -\n - Single Daily Dosing up to 400 mg and Multiple Daily Dosing of 300 mg were Found to Be Safe and Well-Tolerated in Healthy Human Subjects (With No Maximum Tolerated Dose Established) and the Investigated Doses are Believed to be Well Within the Potential Therapeutic Window of IMU-935 -\n - Newly Available Preclinical in vivo Mouse Model Data Further Corroborates Previously Published in vitro Data Showing That, Compared To Two Known RORγt Inhibitors, Exposure to IMU-935 Allows Normal Thymocyte Maturation -\n - Webcast to be Held Today, December 14, 2021, at 8:00 am ET -\n\n\nNEW YORK, Dec. 14, 2021 /PRNewswire/ -- 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 positive 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 clinical trial of IMU-935 in healthy human subjects. In addition, the company announced newly available preclinical in vivo data showing that IMU-935 maintains normal thymocyte maturation in relevant acute and chronic mouse models.\nIn the SAD portion of the phase 1 clinical trial, healthy human subjects were randomized in a double-blinded fashion to either placebo or treatment with single ascending doses of a new powder-in-capsule formulation of IMU-935 at 100 mg, 200 mg, 300 mg and 400 mg. A dose-proportional PK profile was observed across the investigated dose range. Moreover, single ascending doses of IMU-935 were found to be safe and well-tolerated and no maximum tolerated dose was reached. No serious adverse events occurred. These favorable results allowed a smooth transition to the MAD part of the trial using the new formulation.\nIn the MAD part of this phase 1 clinical trial, healthy human subjects were dosed for 14 days with 150 mg once daily (QD) or 150 mg twice daily (BID) of IMU-935 or placebo in a double-blinded fashion. PK analysis showed that stable steady-state plasma concentrations were achieved within the first week of dosing with an accumulation factor fo...