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Inimmune Corporation Commences Human Clinical Trial of INI-2004, a Novel Intranasal TLR4 Agonist for Allergic Rhinitis Treatment, after FDA Approval of IND Application

Thursday, August 03, 2023

Inimmune Corporation, a clinical-stage company dedicated to developing innovative immunotherapeutics, has reported a significant milestone in its journey towards treating allergic rhinitis. The company recently dosed its first subject in a Phase 1/1b First-in-Human clinical trial of INI-2004, an intranasal TLR4 agonist product candidate designed to potentially address allergic rhinitis.

The Phase 1/1b trial is a randomized, double-blind, placebo-controlled, dose-escalating study. Its main objectives are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of INI-2004 in both healthy volunteers and participants with allergic rhinitis (AR). The Phase 1 part is a single ascending dose (SAD) study with up to 4 cohorts, where healthy volunteers are randomly assigned to receive a single intranasal dose of either INI-2004 or a placebo. This phase of the trial is being conducted in Australia under the oversight of the Therapeutic Goods Administration (TGA) and the Human Research Ethics Committee (HREC).

In addition, Inimmune has received clearance from the U.S. Food and Drug Administration (FDA) to initiate the Phase 1b part of the trial in the United States. The Phase 1b segment is a multiple ascending dose (MAD) study with up to 3 cohorts, where participants with seasonal allergic rhinitis will be randomly assigned to receive multiple intranasal doses of INI-2004 or a placebo.

Dr. Thomas Casale, Director of the Division of Allergy and Immunology Joy McCann Culverhouse Clinical Research Center at the University of South Florida, expressed optimism about the potential of INI-2004. He believes the treatment has the capacity to address the underlying immunologic mechanisms responsible for allergic inflammation and symptoms, thus offering a novel solution to a significant medical need for patients suffering from allergic rhinitis.

INI-2004 is an allergen-agnostic immunotherapy that activates Toll-Like Receptor 4. In pre-clinical animal models, it has shown promising results by significantly reducing allergic rhinitis measures, such as airway resistance, eosinophil influx, and cytokine production associated with AR. If the clinical trials prove successful, INI-2004 could become a first-in-class, disease-modifying treatment for allergic rhinitis, capable of treating various allergens and potentially revolutionizing the management of allergic conditions worldwide.

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