Inimmune Corporation, a clinical-stage biotechnology company focused on developing next-generation immunotherapies, has initiated a pivotal Phase 2 clinical trial of INI-2004 in patients with allergic rhinitis.

The Phase 2 study is a randomised, double-blind, placebo-controlled allergen chamber trial being conducted in Kingston, Ontario, Canada. It is designed to evaluate the safety and efficacy of INI-2004 compared with placebo in patients exposed to controlled ragweed allergen challenge conditions.

The primary endpoint of the trial is the improvement in Total Nasal Symptom Score (TNSS) among patients treated with INI-2004 prior to allergen exposure versus those receiving placebo. TNSS is a validated clinical measure that assesses key nasal symptoms of allergic rhinitis, including nasal congestion, runny nose, itching and sneezing.

Commenting on the development, David Burkhart, PhD, Chief Executive Officer, Inimmune, said the trial represents an important milestone for patients who continue to experience persistent symptoms despite existing treatment options. He noted that by targeting the immune pathways that drive allergic disease, INI-2004 aims to deliver more durable improvements beyond short-term symptom relief.

Dr. Jon Ruckle, Chief Medical Officer of Inimmune, also added, “The study marks a significant step toward advancing new therapeutic options for the millions of people affected by allergies worldwide.

Allergic rhinitis impacts hundreds of millions of individuals globally and remains an area of substantial unmet medical need. INI-2004 has been designed to modulate the underlying immune response associated with allergic disease, with the potential to provide meaningful and sustained symptom control.

Patient enrollment for the Phase 2 trial is expected to begin this month, with topline results anticipated in late May 2026. Inimmune also plans to initiate a food allergy clinical trial with INI-2004 in early 2027, expanding the programme’s clinical development.