Inmagene Announces Phase 2a Results for IMG-007 in Alopecia Areata Patients

Inmagene Biopharmaceuticals has announced promising findings from their Phase 2a clinical trial of IMG-007, targeting patients with severe alopecia areata (AA). This clinical-stage biotechnology firm is focused on creating innovative therapies for immunological and inflammatory diseases. The trial involved a total of 29 adult participants with significant scalp hair loss, defined by a Severity of Alopecia Tool (SALT) score of 50 or greater. The trial aimed to evaluate the safety, pharmacokinetics, and therapeutic efficacy of IMG-007.

Two cohorts were involved in the study. Cohort 1 received three doses of 300 mg of IMG-007 intravenously over a four-week period, while Cohort 2 received an increased dosage of 600 mg across the same timeframe. While patients in Cohort 1 did not exhibit a significant reduction in their SALT scores by Week 24, those in Cohort 2 demonstrated more notable improvements. By Week 24, Cohort 2 recorded a mean reduction in SALT scores of 14.3%. This improvement increased to a 21.7% reduction by Week 36, showcasing sustained progress well beyond the cessation of treatment.

In particular, patients within Cohort 2 who began with baseline SALT scores between 50 and 95 showed better outcomes. At Week 36, these individuals achieved an average 30.1% reduction in SALT scores, and a significant proportion also reached a 30% or greater reduction from their baseline scores.

Inflammatory markers common in AA, such as Th1, Th2, and CD8+ T cells, were notably present in patient scalp biopsies at the beginning of the trial. However, following the IMG-007 treatment, a substantial decrease in these markers was observed by Week 16, maintaining this effect three months after the last administered dose. The trial results suggested that the treatment was generally well-tolerated, with no serious adverse events reported. Common mild to moderate treatment-emergent adverse events included headache, nasopharyngitis, hypertension, and streptococcal infection, with no cases of pyrexia or chills.

Jonathan Wang, CEO of Inmagene, highlighted the novelty and potential of IMG-007 in treating alopecia areata by targeting the OX40-OX40L signaling pathway. This study’s outcomes suggest that blocking this pathway could offer a new therapeutic approach for AA, a condition marked by significant unmet treatment needs. Currently, the only systemic treatment options for AA are oral JAK inhibitors, which necessitate regular dosing and come with severe safety warnings, requiring constant monitoring. Thus, a biologic therapy like IMG-007 could represent a safer and long-term solution.

Inmagene’s Chief Medical Officer, Yufang Lu, pointed out that the results from Cohort 2 are promising, indicating that IMG-007 could become an effective long-term biologic therapy for AA. The company plans to present detailed data from this study at an upcoming scientific conference.

Inmagene Biopharmaceuticals is committed to advancing therapeutics for immunological and inflammatory diseases, with multiple drug candidates showcasing best-in-class potential. Their lead asset, IMG-007, is being developed not only for alopecia areata but also for moderate-to-severe atopic dermatitis. As the company progresses through clinical phases, it remains focused on delivering innovative treatments that address significant gaps in current immune and inflammatory disease management.