For ongoing clinical trial information: NCT06038279
At Inimmune, we’re developing a rapid disease-modifying treatment for allergies which does not require identification of the allergen. In the US, nearly 1 in 3 adults and more than 1 in 4 children report having a seasonal allergy, eczema, or food allergy. Worldwide, an estimated 220 million people are affected by food allergies. The prevalence of airborne and food-based allergies has increased over the last several decades and this trend is expected to continue.
The only disease modifying therapy which is currently available to patients is allergen specific immunotherapy (AIT). AIT is a targeted treatment consisting of a small amount of allergen extract injected subcutaneously in the case of airborne allergens, or delivered orally for peanut allergy over the course of a few years. AIT requires long-term commitment (3 to 5 years), resulting in low patient adherence and high patient costs.
INI-2004 is an allergen agnostic immunotherapy that binds and activates toll-like receptor 4 (TLR4). In response to the ragweed challenge, participants in our Phase I study treated with INI-2004 intranasally showed a dose-dependent improvement in nasal congestion as measured by acoustic rhinometry compared to placebo participants. Participants treated with INI-2004 also 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. We plan to follow up with an allergen chamber study to demonstrate further measures of efficacy in Q1 2025. Successful completion of a chamber study using intranasal INI-2004 will lead to a first-in-class, rapid, disease-modifying treatment that may be used for any allergen, potentially changing how allergies are treated worldwide. To learn more about our ongoing clinical trial, please visit www.clinicaltrials.gov.
To treat food allergy, we are collaborating with Intrommune, a clinical stage biotech company pursuing the development of toothpaste-based food allergy treatment. Their first product, INT301, a toothpaste containing allergenic peanut proteins, was shown to be safe in people with peanut allergy in a Phase I clinical trial. We are currently evaluating whether the addition of INI-2004 to INT301 can enhance the desensitization response in pre-clinical models.
We are also collaborating with Duke and UNC to demonstrate the efficacy of INI-2004 as an adjuvant for sublingual immunotherapy (SLIT) in pre-clinical peanut allergy models via NIH funding.
