Inimmune Reports Successful Phase 1 Results for Allergy Treatment INI-2004

MISSOULA, Mont., May 15, 2024 -- Inimmune, a prominent biotech firm specializing in vaccine adjuvants, immunotherapies, and delivery systems, has shared the primary findings from its Phase 1b Multiple Ascending Dose (MAD) study of INI-2004, aimed at individuals suffering from Allergic Rhinitis (NCT06038279). The study revealed that participants treated with INI-2004 showed a dose-dependent reduction in nasal congestion when exposed to ragweed, as assessed by acoustic rhinometry. Furthermore, those receiving INI-2004 exhibited higher cytokine biomarkers from nasal swab samples in comparison to those on a placebo. All doses of INI-2004 were well tolerated, and no maximum tolerated dose (MTD) was identified. This follows the successful completion of Inimmune's Phase 1a Single Ascending Dose (SAD) study of INI-2004 in healthy volunteers.

Conducted as a randomized, placebo-controlled, double-blind study with 35 participants, INI-2004, a synthetic Toll-Like Receptor (TLR) 4 agonist in a mucosal formulation, was administered intranasally to individuals allergic to ragweed. The treatment was well tolerated, with adverse events (AEs) primarily being mild, transient, and occurring at similar rates across both the INI-2004 and placebo groups. Although this Phase 1b study was designed primarily for safety assessment rather than efficacy, differences in nasal volume were noted between groups. Participants initially exposed to ragweed allergen to induce a 30% reduction in nasal volume, a measure of nasal congestion, were deemed eligible. They then received four weekly intranasal doses of 125, 250, or 500 µg of INI-2004 or placebo, followed by ragweed challenges after the second and fourth administrations. Acoustic rhinometry was conducted several times throughout the study. Participants receiving 250 µg and 500 µg doses of INI-2004 showed 34% and 53% improvement, respectively, in nasal volume post-ragweed challenge compared to the placebo group.

Inimmune's CEO, Alan Joslyn, expressed satisfaction with the results, stating, "We are pleased to see that INI-2004 was very well tolerated at all dose levels and after multiple treatments. It's also exciting that INI-2004 showed an early objective efficacy signal in improved congestion for these allergy sufferers relative to placebo despite the small number of participants evaluated. We look forward to demonstrating more symptom-focused measures of efficacy in an upcoming allergen challenge chamber study in patients with moderate to severe ragweed allergy."

About INI-2004:
INI-2004 is a unique immunotherapy that targets and activates Toll-Like Receptor 4 when administered intranasally. Pre-clinical animal models indicated that INI-2004 substantially reduced symptoms of allergic rhinitis (AR), including airway resistance, eosinophil influx, and cytokine production linked to AR's pathogenesis. Demonstrating both safety and efficacy in humans could establish INI-2004 as a pioneering, disease-modifying treatment for AR, applicable to a variety of allergens, potentially transforming the approach to treating AR and allergic conditions globally.

About Inimmune:
Inimmune Corp., based in Missoula, MT, is a clinical-stage biotechnology company committed to discovering and developing innovative immunotherapeutics, vaccine adjuvants, and vaccines. By leveraging the human immune system, Inimmune aims to create safe and effective treatments for allergies, infectious diseases, autoimmune disorders, and cancer. The company operates out of the Montana Technology Enterprise Center (MonTEC) in Missoula.

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