Inimmune Corporation announces First Subject Dosed in First-in-Human Phase 1 Clinical Trial of its novel intranasal TLR4 agonist, INI-2004, for the Treatment of Allergic Rhinitis and FDA Clearance of IND application for INI-2004

Milestone marks transition of Inimmune Corporation to a clinical-stage company

MISSOULA, Mont., Aug. 2, 2023 /PRNewswire/ -- Inimmune Corporation ("Inimmune"), a clinical-stage company focused on the development of innovative immunotherapeutics, today announced that the first subject has been dosed in Inimmune's phase 1/1b First-in-Human clinical trial of INI-2004, Inimmune's TLR4 agonist product candidate under development as a potential treatment of allergic rhinitis.

The phase 1/1b trial is a randomized, double-blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of INI-2004 in healthy volunteers and participants with allergic rhinitis (AR). The phase 1 trial is a single ascending dose (SAD) study with up to 4 cohorts, and healthy volunteers are to be randomized 3:1 to receive a single intranasal dose of INI-2004 or placebo.  This portion of the study is being conducted in Australia under Therapeutic Goods Administration (TGA) authority and Human Research Ethics Committee (HREC) oversight.

"Australia is the ideal location for us to conduct a cost-effective, high-quality phase 1 study," said Jon Ruckle, MD, CMO. "We already have in place an Australian subsidiary, an experienced phase 1 clinical site, and a relationship with a well-respected local contract research organization."

Inimmune also announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate the phase 1b portion of the trial in the U.S. The phase 1b portion of the trial is a multiple ascending dose (MAD) study with up to 3 cohorts where subjects with seasonal allergic rhinitis are to be randomized 3:1 to receive multiple intranasal doses of INI-2004 or placebo.

Thomas Casale, MD, Director, Division of Allergy and Immunology Joy McCann Culverhouse Clinical Research Center, University of South Florida said "Despite the availability of many different therapies for the treatment of allergic rhinitis, a large proportion of the 20 to 30% of the US population suffering from allergic rhinitis still has significant symptoms and impaired quality of life. INI-2004 has the potential to provide a novel treatment that addresses the underlying immunologic mechanisms responsible for allergic inflammation and symptoms, thereby addressing a significant medical need."

"We are thrilled to have accomplished these momentous milestones. These are important milestones for our company, representing our first program to receive FDA clearance to enter the clinic and our first dosing in a FIH clinical trial, demonstrating our drug discovery and clinical development capabilities," said Alan Joslyn, Ph.D., Inimmune's CEO. "INI-2004 leverages our groundbreaking science as it was designed to be allergen-agnostic and can potentially be an effective treatment for multiple allergic diseases."

About INI-2004
INI-2004 is an allergen-agnostic immunotherapy that binds and activates Toll-Like Receptor 4. When delivered intranasally, INI-2004 dramatically reduced measures of allergic rhinitis (AR) in pre-clinical animal models. These include airway resistance, eosinophil influx, and the production of cytokines involved in the pathogenesis of AR. Demonstration of safety and efficacy in people will lead to a first-in-class, disease-modifying treatment for AR that may be used for a wide range of allergens, potentially changing how AR and allergic conditions are treated worldwide.

About Inimmune Corporation
Inimmune Corp. (Missoula, MT) is a privately held biotechnology company focused on the discovery and development of innovative immunotherapeutics, vaccine adjuvants, and vaccines. Inimmune is harnessing the human immune system to create safe and effective treatments for allergy, infectious disease, autoimmunity, and cancer.   Their laboratories and offices are housed in the Montana Technology Enterprise Center (MonTEC) in Missoula.

For more information on Inimmune's research and development of novel vaccine adjuvants, immunotherapeutics and delivery systems, please visit www.inimmune.com.

Contact:
Media Relations
Inimmune Corporation
Phone: (406)-541-5913
Email: [email protected]

SOURCE Inimmune