INI-2004 / Inimmune - LARVOL DELTA

Environmental Exposure Unit Trial in Subjects With Ragweed-induced Allergic Rhinitis (clinicaltrials.gov) - P2 | N=78 | Completed | Sponsor: Inimmune Corporation

New P2 trial • Allergic Rhinitis • Immunology • Inflammation

Synthetic TLR4 agonist rapidly reduces TNSS in ragweed-allergic subjects in a Phase 1 NAC trial (AAAAI 2026) - P1 | "Advanced regression analysis of TNSS changes using a pooled analysis of all INI-2004 treated groups vs placebo and the creation of virtual twins for each subject in the treatment arms and placebo arms demonstrated that the treatment effect of INI-2004 on TNSS was statistically significant (p = 0.0182) after the third ragweed challenge. Conclusions INI-2004 significantly reduced TNSS vs placebo after challenge for up to 16 days post-treatment, suggesting a rapid and durable disease-modifying effect on ragweed allergy."

Clinical • Late-breaking abstract • P1 data • Immunology • TLR4

Trial of INI-2004 in Healthy Volunteers and Participants With Allergic Rhinitis. (clinicaltrials.gov) - P1 | N=68 | Completed | Sponsor: Inimmune Corporation | Recruiting ➔ Completed

Trial completion • Allergic Rhinitis • Immunology • Inflammation

Generation of a shelf-stable, broadly-reactive influenza vaccine formulated with TLR4, TLR7/8, or TLR9 stimulating adjuvants. (PubMed, Vaccine) - "Influenza H1 and H3 hemagglutinin proteins based upon the computationally-optimized broadly-reactive antigen (COBRA) methodology were mixed with one of three toll-like receptor (TLR) agonists, CpG1826 (TLR9 agonist), INI-2002 (TLR4 agonist), or INI-4001 (TLR7/8 agonist)...However, all vaccinated ferrets from these groups were protected against an H1N1 influenza virus challenge, irrespective of the adjuvant. Overall, the constituted vaccines used following the TFF process were effective at eliciting protective immune responses following intranasal administration to ferrets."

Journal • Infectious Disease • Influenza • Respiratory Diseases • TLR4 • TLR7 • TLR9

Development of analytical assays for the determination of a diamino allose phosphate, INI-2004, to support GMP stability studies (ACS-Fall 2025) - "Both methods presented issues related to either sensitivity or gradient complexity, and low accuracy at nanomolar levels. Ultimately, the CAD-UPLC method was validated for release and GMP stability studies."

Allergic Rhinitis • Immunology • Inflammation • TLR4

Intranasal INI-2004, a novel synthetic TLR4 agonist, is safe, well tolerated, and alleviates nasal congestion in patients with allergic rhinitis: a randomized, double-blind phase I/Ib study (AAAAI-WAO 2025) - P1 | "Conclusions Intranasal INI-2004 is safe and well tolerated in healthy adults and participants with AR. INI-2004 alleviated nasal congestion in response to ragweed challenge compared to placebo."

Clinical • P1 data • Allergic Rhinitis • Immunology • Inflammation • TLR4

Phase 1 Clinical Results for INI-2004: An Intranasal Allergen-Agnostic Immunotherapy (WVCE 2024) - "Sponsored by: Abera Bioscience Ab; Sponsored by: Orlance, Inc.; Sponsored by: Givax Inc.; Sponsored by: Intravacc; Sponsored by: Hisamitsu Pharmaceuticals; Sponsored by: Transmucosis"

Clinical • P1 data

Intranasal administration of a synthetic TLR4 agonist INI-2004 significantly reduces allergy symptoms following therapeutic administration in a murine model of allergic sensitization. (PubMed, Front Immunol) - "These findings lay the groundwork for the ongoing clinical evaluation of INI-2004 in allergic rhinitis as a stand-alone therapy for individuals poly-sensitized to multiple seasonal allergens. The study underscores the significance of innovative immunotherapy approaches in reshaping the landscape of allergic rhinitis management."

Journal • Preclinical • Allergic Rhinitis • Allergy • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • TLR4

Trial of INI-2004 in Healthy Volunteers and Participants With Allergic Rhinitis. (clinicaltrials.gov) - P1 | N=68 | Recruiting | Sponsor: Inimmune Corporation

New P1 trial • Allergic Rhinitis • Immunology • Inflammation

Inimmune Corporation announces First Subject Dosed in First-in-Human Phase 1 Clinical Trial of its novel intranasal TLR4 agonist, INI-2004, for the Treatment of Allergic Rhinitis and FDA Clearance of IND application for INI-2004 (PRNewswire) - "Inimmune Corporation...announced that the first subject has been dosed in Inimmune's phase 1/1b First-in-Human clinical trial of INI-2004, Inimmune's TLR4 agonist product candidate under development as a potential treatment of allergic rhinitis....Inimmune also announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate the phase 1b portion of the trial in the U.S."

Trial status • Allergic Rhinitis • Immunology • Respiratory Diseases