US-based biotechnology company Inimmune has dosed the first subject in a randomised, placebo-controlled Phase I/Ib study of INI-2004 to treat allergic rhinitis.
The first phase of the trial will be carried out as a single-ascending-dose study of the Toll-Like Receptor 4 (TLR4) agonist product candidate INI-2004.
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It will be conducted in Australia under the supervision of the Therapeutic Goods Administration Authority and the Human Research Ethics Committee.
Up to four cohorts will be included in Phase I, with healthy patients to be randomised at a 3:1 ratio to receive a single intranasal INI-2004 dose or placebo.
Inimmune chief marketing officer Jon Ruckle said: “Australia is the ideal location for us to conduct a cost-effective, high-quality Phase I study.
“We already have in place an Australian subsidiary, an experienced Phase I clinical site, and a relationship with a well-respected local contract research organisation.”
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By GlobalDataFor Phase Ib of the study, Inimmune has also received an investigational new drug application approval from the US Food and Drug Administration
This phase will be carried out in the US and include a multiple ascending dose study of three cohorts.
Patients with seasonal allergic rhinitis will be randomised AT A 3:1 ratio to receive INI-2004’s multiple intranasal doses or placebo.
Inimmune CEO Alan Joslyn said: “These are important milestones for our company, representing our first programme to receive FDA clearance to enter the clinic and our first dosing in an FIH clinical trial, demonstrating our drug discovery and clinical development capabilities.
“INI-2004 leverages our groundbreaking science as it was designed to be allergen-agnostic and can potentially be an effective treatment for multiple allergic diseases.”
Based in Missoula, Montana, Inimmune is also working to develop vaccines, vaccine adjuvants and immunotherapeutics for treating cancer, autoimmunities, infectious diseases and allergies.
