IMG-007 Phase 2a Enrollment Complete for Alopecia Areata Trial

Inmagene Biopharmaceuticals, a clinical-stage biotechnology firm, has achieved a significant milestone in its research into immunological and inflammatory diseases. The company has completed the recruitment phase for a Phase 2a trial involving IMG-007, a monoclonal antibody designed to target the OX40 protein, in adult patients suffering from alopecia areata (AA). This follows the completion of enrollment for a similar study in patients with atopic dermatitis (AD).

IMG-007 is a unique monoclonal antibody that has been engineered to reduce the risk of adverse effects by silencing the antibody-dependent cellular cytotoxicity (ADCC) function and extending its half-life, which allows for less frequent dosing intervals. The open-label Phase 2a trial, which is registered under the identifier NCT06060977, has enrolled 29 patients with AA who have experienced significant scalp hair loss. Participants will receive three intravenous infusions of either 300 mg or 600 mg of IMG-007 over a four-week period and will be monitored for 24 weeks post-treatment.

The primary goals of the study are to evaluate the safety and effectiveness of IMG-007. The severity of alopecia will be measured using the Severity of Alopecia Tool (SALT) score. Dr. Yufang Lu, Chief Medical Officer at Inmagene, highlighted the importance of the OX40-OX40L signaling pathway in the development of AA and emphasized that IMG-007 is the first antagonist targeting this pathway to be tested in a clinical trial for AA patients. The study will also include a comprehensive biomarker analysis to provide deeper insights into how OX40 inhibition can influence the disease's pathophysiology and its correlation with clinical outcomes.

Inmagene is a global clinical-stage biotechnology company that is dedicated to developing innovative treatments for a range of immunological and inflammatory diseases. The company's pipeline includes several promising candidates with the potential to be best-in-class treatments. In addition to IMG-007, which is being tested in two global Phase 2a trials for AD and AA, Inmagene is also advancing IMG-004, a non-covalent, reversible Bruton's tyrosine kinase (BTK) inhibitor with a long half-life and pharmacodynamic effect, which could enable once-daily dosing. Another candidate, IMG-008, a long-acting anti-IL-36R monoclonal antibody, is set to enter global Phase 1 clinical development.

The company's lead asset, IMG-007, is a humanized anti-OX40 IgG1 monoclonal antibody that has demonstrated a 31-day half-life at therapeutic dose levels during a Phase 1 study, supporting the potential for once every 12 weeks dosing. The antibody has shown a favorable safety profile without any reports of fever or chills, which are common side effects associated with other treatments.

Inmagene is committed to advancing its pipeline and is focused on delivering transformative therapies for patients with immunological and inflammatory conditions. The company's dedication to innovation and excellence is evident in its approach to drug development, which aims to improve the lives of those affected by these complex diseases.

The initial findings from the Phase 2a trial for AA are expected to be released in the fourth quarter of 2024, marking a crucial step forward in the understanding and treatment of this condition. Inmagene's continued progress in clinical trials and drug development underscores its position at the forefront of biotechnology research and its potential to make a significant impact on the treatment of immunological and inflammatory diseases.