MISSOULA, MT, USA I May 15, 2024 I Inimmune, a leading clinical stage biotech company focused on the development of novel vaccine adjuvants, immunotherapies and delivery systems, announced today the top line results from its Phase 1b Multiple Ascending Dose (MAD) study of INI-2004 in people suffering with Allergic Rhinitis (NCT06038279). In response to ragweed challenge, participants treated with INI-2004 showed a dose dependent improvement in nasal congestion as measured by acoustic rhinometry compared to placebo participants. Participants treated with INI-2004 exhibited a dose dependent trend towards higher cytokine biomarkers from nasal swab samples compared to placebo. Additionally, all doses of INI-2004 were well tolerated over multiple administrations and no MTD was reached. This follows Inimmune’s successful completion of its Phase 1a Single Ascending Dose (SAD) study of INI-2004 in healthy volunteers.

Using a randomized, placebo-controlled, double-blind study design (n=35), INI-2004, a synthetic Toll Like Receptor (TLR) 4 agonist in a mucosal formulation, was delivered intranasally to participants with ragweed allergy. INI-2004 was well tolerated. The adverse events (AEs) were mostly mild in severity, transient, and occurred at a similar rate across INI-2004 and placebo groups. Although this Phase 1b safety study was not powered to measure efficacy, a difference was observed in measured nasal volume between groups. For eligibility, participants were initially dosed with ragweed allergen to produce a 30% decrease in nasal volume, a measure of nasal congestion, as determined by acoustic rhinometry. Eligible participants then received four weekly intranasal administrations of 125, 250, or 500 µg INI-2004 or placebo followed by ragweed challenge after the second and fourth administrations. Acoustic rhinometry was completed multiple times over the course of the study. Participants who received 250 µg and 500 µg doses of INI-2004 had, on average, 34% and 53% improvement, respectively, in nasal volume post ragweed challenge compared to placebo.

Inimmune’s CEO, Alan Joslyn, said “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 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:
Inimmune Corp. (Missoula, MT) is a privately held clinical stage 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 and delivery systems, please visit www.inimmune.com.

SOURCE: Inimmune