INI-2004 advances as a rapid, disease-modifying immunotherapy for allergic rhinitis with platform potential across all allergic diseases; topline data expected June 2026

MISSOULA, Mont., March 12, 2026 /PRNewswire/ — Inimmune Corporation, a clinical-stage biotechnology company developing novel immunotherapies for allergic diseases, today announced the completion of enrollment and dosing of the first patient in its Phase 2 allergen challenge chamber trial evaluating INI-2004 in patients with allergic rhinitis.

“Allergic rhinitis affects hundreds of millions of people worldwide, yet treatment options remain largely limited to symptom control or lengthy allergen-specific immunotherapy programs,” said David Burkhart, Ph.D., CEO of Inimmune Corporation. “Completing enrollment and dosing the first patient in our Phase 2 study is a significant step toward demonstrating that INI-2004 can rapidly and durably modify the immune response driving allergic disease. We look forward to reporting topline data from the study in June.”

The randomized, placebo-controlled Phase 2 trial is designed to evaluate the safety, tolerability, and efficacy of INI-2004 in patients with allergic rhinitis using a validated allergen exposure chamber model. INI-2004 targets innate immune pathways that drive allergic inflammation and is designed to rapidly reprogram immune responses to allergens, potentially delivering a disease-modifying effect independent of the specific allergen trigger.

“We believe INI-2004 represents a true ‘pipeline in a product,'” said Ferdinand Massari, M.D., Chief Medical Officer of Inimmune Corporation. “By targeting core innate immune pathways involved in allergic disease, this program has the potential to extend beyond seasonal and perennial allergic rhinitis into additional indications, such as food allergies, allergic asthma, and other atopic conditions. Our goal is to deliver a disease-modifying immunotherapy that simplifies treatment for patients and clinicians while transforming how allergic diseases are managed.”

Following completion of the Phase 2 allergen chamber study, Inimmune plans to engage with regulatory authorities to determine the path forward for late-stage clinical development and potential expansion into additional allergic and asthma-related indications.

About INI-2004

INI-2004 is an investigational, allergen-agnostic immunotherapy designed to reprogram immune responses to allergens by activating toll-like receptor 4 (TLR4), a key pathway involved in innate immune signaling. By targeting core immune mechanisms underlying allergic disease, INI-2004 is being developed as a rapid, disease-modifying treatment that may be effective across multiple allergens.

Inimmune is advancing INI-2004 into clinical studies designed to further evaluate its safety and efficacy in allergic rhinitis and other allergic diseases.

About Inimmune Corporation
Inimmune is a clinical-stage biotechnology company focused on the discovery and development of next-generation immunotherapies for the treatment of infectious diseases, allergy, and cancer. Leveraging its proprietary technology platforms, Inimmune is dedicated to creating safe and effective treatments that harness the immune system to improve patient outcomes. For more information, follow us on LinkedIn and visit www.inimmune.com/.

For more information about Inimmune Corporation, contact:

Email: [email protected]

Phone: 406-541-5913

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