Missoula, Montana – January 7, 2026 – Inimmune Corporation (“Inimmune”), a clinical-stage biotechnology company focused on developing innovative immunotherapies, today announced the start of its pivotal Phase 2 clinical trial evaluating INI-2004 in patients with allergic rhinitis.
The Phase 2 study is a randomized, double blind, placebo-controlled allergen chamber trial being conducted in Kingston, Ontario, Canada. The trial is designed to assess the efficacy and safety of INI-2004 compared with placebo in patients with allergic rhinitis exposed to controlled ragweed allergen challenge conditions.
The primary endpoint of the study is improvement in Total Nasal Symptom Score (TNSS) in patients treated with INI-2004 before the allergen exposure compared to those receiving placebo. TNSS is a well-established clinical measure that evaluates key nasal symptoms associated with allergic rhinitis, including congestion, rhinorrhea, nasal itching, and sneezing.
“This trial marks a critical step forward for patients suffering from allergic rhinitis, many of whom continue to experience persistent symptoms, despite existing treatment options,” said David Burkhart PhD, Chief Executive Officer of Inimmune. “By targeting the immune mechanisms that perpetuate allergic disease, INI-2004 has the potential to offer a new therapeutic approach focused not just on symptom control, but on lasting improvement in patients’ daily quality of life.” Chief Medical Officer Dr. Jon Ruckle added, “We believe this study is an important milestone in advancing better solutions for the millions of people affected by all allergies worldwide.”
Allergic rhinitis affects hundreds of millions of people globally and remains an area of significant unmet medical need despite the availability of current therapies. INI-2004 is designed to modulate immune responses underlying allergic disease, with the goal of providing meaningful and durable symptom relief.
Enrollment in the Phase 2 trial is expected to begin this month with topline results expected in late May of 2026. Inimmune intends to expand into a food allergy clinical trial with INI-2004 in early 2027.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the clinical development, potential benefits, and future prospects of INI-2004. These statements are subject to risks and uncertainties that could cause actual results to differ materially. Inimmune undertakes no obligation to update any forward-looking statements.
