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Immunic Announces Positive Results from Single and Multiple Ascending Dose Parts of Its Phase 1 Clinical Trial of IMU-856 in Healthy Human Subjects
– Unblinded Data Revealed a Favorable Safety, Tolerability and Pharmacokinetic Profile for IMU‑856 in Single and 14-Day Multiple Dosing – – No Maximum
About this update from Immunic, Inc.
[{"type":"text","content":"– Unblinded Data Revealed a Favorable Safety, Tolerability and Pharmacokinetic Profile for IMU‑856 in Single and 14-Day Multiple Dosing –\n– No Maximum Tolerated Dose Reached; Investigated Doses Expected to Exceed Required Therapeutic Dosing of IMU-856 –\n– Third Portion of Phase 1 Clinical Trial in Patients with Celiac Disease Ongoing –\n– Webcast to be Held Today, September 20, 2022, at 8:30 am ET –\nNEW YORK, Sept. 20, 2022 /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-856 in healthy human subjects. IMU-856 is an orally available and systemically acting small molecule modulator that targets a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium.\nIn the SAD part of the phase 1 clinical trial, healthy human subjects were randomized in a double-blinded manner 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. No serious adverse events occurred. Moreover, a dose-linear PK profile was observed across the investigated dose range. These favorable results allowed a smooth transition to the MAD part of the trial.\nIn the MAD part of this phase 1 clinical trial, healthy human subjects were dosed for 14 consecutive days with 40 mg, 80 mg or 160 mg once-daily of IMU-856 or placebo in a double-blinded manner. 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 (TEAEs) were mostly mild in severity. No Investigational Medicinal Product (IMP)-related serious adverse events were reported. No dose-dependent changes in laboratory parameters (including no effects on liver enzymes or in hematological parameters), vital signs, physical examination or electrocardiographic evaluations were found. PK analysis showed a q...