Inmagene Biopharmaceuticals has successfully dosed the first patient in its global multicenter Phase 2b dose-finding study of IMG-007, a novel anti-OX40 monoclonal antibody for treating moderate-to-severe atopic dermatitis. The ADAPTIVE trial (NCT07037901) represents a significant milestone for the clinical-stage biotechnology company's lead therapeutic candidate.
"We are thrilled to have the first patient dosed in this trial, building on the encouraging clinical data observed earlier," said Jonathan Wang, PhD, Founder, Chairman, and Chief Executive Officer of Inmagene. "IMG-007 targets the OX40 receptor, blocking OX40–OX40L signaling in both the bloodstream and tissues, while its silenced antibody-dependent cell-mediated cytotoxicity function abolishes T-cell depleting effect, thereby potentially minimizing safety risks."
Trial Design and Patient Population
The ADAPTIVE trial is a randomized, double-blind, placebo-controlled Phase 2b study designed to evaluate the efficacy and safety of several subcutaneous dose regimens of IMG-007. The trial aims to enroll approximately 220 adult participants with active moderate-to-severe atopic dermatitis who have had inadequate response to and/or intolerance of topical therapies.
Patients will be randomized across four treatment arms in a 1:1:1:1 ratio, including high, medium, and low doses of IMG-007, plus placebo. The study consists of two distinct treatment periods: a 20-week randomized double-blind, placebo-controlled treatment period, followed by a 32-week double-blind active treatment period during which all participants, including those initially randomized to placebo, will receive active treatment.
Primary and Secondary Endpoints
The primary endpoint focuses on mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 20. Key secondary endpoints include mean percentage change from baseline in EASI score at Week 16, as well as proportion of patients achieving EASI-75 (≥ 75% improvement in EASI score) and Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear) at Week 16 and 20, respectively.
IMG-007 Mechanism and Characteristics
IMG-007 is a humanized, subcutaneously administered, non-depleting IgG1 monoclonal antibody targeting OX40. The therapeutic features a silenced antibody-dependent cell-mediated cytotoxicity function and an extended half-life. The OX40–OX40L signaling pathway plays a key role in T cell activation, expansion, and survival, making it an attractive target for treating immunological and inflammatory diseases.
In nonclinical studies, IMG-007 demonstrated potent inhibition of OX40–OX40L signaling. Its subcutaneous formulation has shown a half-life of 34.7 days at the anticipated therapeutic dose level, supporting the potential for infrequent and convenient dosing. Wang emphasized that the extended half-life supports convenient dosing, and together with other attributes, makes IMG-007 "a potentially differentiated therapeutic candidate for AD patients."
Previous Clinical Experience
In a Phase 2a trial in patients with moderate-to-severe atopic dermatitis, IMG-007 exhibited sustained clinical activity and was well tolerated, with no reported cases of pyrexia or chills. The drug was originally discovered by HUTCHMED.
Timeline and Future Development
Topline results from the Phase 2b ADAPTIVE trial are expected in the fourth quarter of 2026. This dose-finding study is designed to generate data that will guide the design and selection of optimal dosing regimens for future Phase 3 clinical trials.
Company Pipeline
Inmagene is a global clinical-stage biotechnology company dedicated to developing innovative therapeutics for immunological and inflammatory diseases. The company's lead asset, IMG-007, is currently in Phase 2 development for the treatment of moderate-to-severe atopic dermatitis and alopecia areata. Inmagene's pipeline also includes IMG-004, a non-covalent, reversible oral BTK inhibitor characterized by an extended half-life and sustained pharmacodynamic effect, supporting the potential for once-daily dosing. IMG-004 is ready to advance into Phase 2 clinical development.
