Inmagene Completes Enrollment for IMG-007 Phase 2a Trial in Alopecia Areata

Inmagene Biopharmaceuticals, a clinical-stage biotechnology company specializing in innovative therapies for immunological and inflammatory diseases, has announced the completion of target enrollment for its Phase 2a trial of IMG-007 in adult patients with alopecia areata (AA). This milestone is a significant step forward in the study of IMG-007, a nondepleting anti-OX40 monoclonal antibody (mAb) designed to address specific immunological pathways implicated in AA and atopic dermatitis (AD).

IMG-007 stands out due to its engineered properties, which include a silenced antibody-dependent cellular cytotoxicity (ADCC) function to reduce safety risks and an extended half-life to allow dosing once every 12 weeks. The Phase 2a open-label trial (NCT06060977) enrolled 29 patients suffering from AA who had experienced 50% or greater hair loss on their scalps. These patients were recruited from 11 different sites across the United States and Canada. Participants in the study received three intravenous infusions of either 300 mg or 600 mg of IMG-007 over a period of 4 weeks (administered at Week 0, Week 2, and Week 4) and are being monitored for a follow-up period of 24 weeks. The primary endpoints of the study focus on assessing the safety and efficacy of IMG-007, which will be measured using the severity of alopecia tool (SALT) score.

Dr. Yufang Lu, the Chief Medical Officer of Inmagene, highlighted the significance of the OX40-OX40L signaling pathway in the pathogenesis of AA. Dr. Lu emphasized that IMG-007 is the first OX40/OX40L antagonist to be evaluated in a clinical setting for AA patients. Through this trial, the company aims not only to assess the efficacy of IMG-007 in treating AA but also to perform extensive biomarker analyses to gain deeper insights into how inhibiting the OX40 pathway may influence disease mechanisms and clinical outcomes in AA.

Inmagene is a globally operating clinical-stage biotechnology firm with a strong focus on developing novel treatments for immunological and inflammatory conditions. The company boasts a highly specialized clinical-stage pipeline with several promising candidates that have the potential to be best-in-class treatments. IMG-007 is the leading asset in this pipeline, currently being evaluated in two global Phase 2a clinical trials targeting both atopic dermatitis and alopecia areata. Another notable candidate in the company's pipeline is IMG-004, a non-covalent reversible BTK inhibitor featuring an extended half-life and pharmacodynamic effect, which is nearing the completion of a Phase 1 multiple-dose study. Additionally, IMG-008, a long-acting anti-IL-36R mAb, is preparing to enter global Phase 1 clinical development.

IMG-007 is a humanized anti-OX40 IgG1 monoclonal antibody that is distinct due to its silenced ADCC function and prolonged half-life. The OX40-OX40L axis is crucial for T cell activation, expansion, and survival, making it a significant factor in the development of various immunological and inflammatory diseases. In preclinical studies, IMG-007 effectively blocked the interaction between OX40 and OX40L. A Phase 1 single-dose study revealed a 31-day half-life at anticipated therapeutic dose levels, supporting the potential for once every 12 weeks dosing and showcasing a favorable safety profile with no reports of fever or chills.

As IMG-007 continues to be evaluated for the treatment of moderate-to-severe atopic dermatitis and alopecia areata in ongoing Phase 2a studies, the scientific and medical communities eagerly await the topline results expected in the fourth quarter of 2024. These findings could pave the way for new, effective treatments for patients suffering from these challenging conditions.