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Immunic, Inc. Announces First Psoriasis Patient Enrolled in Ongoing Phase 1 Trial of IMU-935
- Represents the First Time Patients Will Be Treated With the Company's Potentially Best-In-Class RORγt Inverse Agonist - NEW YORK, Oct. 27, 2021 /PRNewswire/
About this update from Immunic, Inc.
[{"type":"text","content":"- Represents the First Time Patients Will Be Treated With the Company's Potentially Best-In-Class RORγt Inverse Agonist -\n\n\nNEW YORK, Oct. 27, 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 enrollment of the first psoriasis patient in Part C of its ongoing phase 1 clinical trial of IMU-935, a highly potent and selective inverse agonist of the transcription factor RORγt.\nPart C is structured as a 28-day, double-blind, placebo-controlled trial designed to enroll approximately 52 patients, randomized 3:1 versus placebo with two treatment cohorts. The primary objective is to evaluate the safety and tolerability of IMU-935 in moderate-to-severe psoriasis patients. Secondary objectives include evaluation of trough plasma concentration levels and effects on skin symptoms utilizing the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), psoriasis affected body surface area (BSA), Physicians Global Assessment (PGA), and Itch Numeric Rating Scale (NRS). The trial also assesses pharmacodynamic marker changes, including serum cytokines, ex vivo peripheral blood mononuclear cell gene expression profiles and histological biomarker analysis in skin biopsies. More than 10 sites in Australia and New Zealand are expected to participate in Part C.\n\"The initiation of treatment of patients with active disease with IMU-935 marks a significant milestone in the continued advancement of our development pipeline,\" stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. \"We chose to target psoriasis as we strongly believe that it provides an ideal pathophysiology to assess safety as well as biomarkers related to IMU-935's mechanism of action. In addition, we believe that there is an urgent medical need to translate the significant therapeutic advances in IL17-targeted therapies in psoriasis into a more convenient oral treatment option for patients. We also eagerly await completion of the single and multiple ascending dose parts of this phase 1 trial in healthy volunteers later in 2021, which, if successful in showing a favorable safety and pharmacokinetic profile for IMU-935, should bolster our thesis behind thi...