Inmagene Announces Positive Interim Phase 2a Results for IMG-007 in Atopic Dermatitis Treatment

Inmagene Biopharmaceuticals, a clinical-stage biotechnology firm dedicated to developing innovative treatments for immunological and inflammatory diseases, has announced promising interim results from its Phase 2a trial of IMG-007 in patients suffering from atopic dermatitis (AD). IMG-007, a nondepleting anti-OX40 monoclonal antibody (mAb), has shown significant and sustained improvements in skin conditions for these patients.

IMG-007 is engineered to silence antibody-dependent cellular cytotoxicity (ADCC) and extend its half-life, enhancing its therapeutic potential. Preliminary studies in healthy adults revealed that IMG-007 has a favorable safety profile, with no reports of fever or chills. The antibody also demonstrated slow clearance from the body and a 31-day half-life at therapeutic doses, suggesting it could be administered every 12 weeks for induction therapy and even less frequently for maintenance therapy.

The Phase 2a trial, registered as NCT05984784, focuses on assessing the safety, pharmacokinetics, and efficacy of IMG-007 in adults with moderate-to-severe AD who have not responded adequately to, or are intolerant of, topical treatments. The trial included patients who had previously been treated with systemic agents like biologics. Participants were ineligible for other AD medications during the trial. Each patient received three intravenous infusions of 300 mg IMG-007 over four weeks and was monitored for 24 weeks. The primary endpoints were safety and the percentage change in eczema area and severity index (EASI) from baseline over time.

Thirteen patients from six centers in the U.S. and Canada were enrolled. At the start of the study, patients had an average EASI score of 29.5 and a mean body surface area (BSA) of 52.0%. Additionally, 61.5% of the patients had an investigator’s global assessment (IGA) score of 3, while 38.5% had an IGA score of 4.

The results indicated a swift and noticeable improvement in EASI scores starting from the first week, with continued progress observed through to the 20th week. The mean percentage improvements from baseline in EASI were as follows: 23% at Week 1, 29% at Week 2, 47% at Week 4, 66% at Week 8, 68% at Week 12, 77% at Week 16, and 87% at Week 20. By the 20th week, 69% of the patients achieved at least a 50% improvement in EASI (EASI-50), 54% achieved at least a 75% improvement (EASI-75), and 31% achieved at least a 90% improvement (EASI-90).

No serious adverse events or treatment discontinuations due to adverse events were reported. The treatment was well-tolerated, with no incidences of fever or chills.

Dr. Jonathan Silverberg, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences, expressed optimism about inhibiting OX40-OX40L signaling as a therapeutic strategy for AD. He highlighted that IMG-007, with its nondepleting action on T cells and extended half-life, could offer a safer and more convenient dosing regimen for patients. Dr. Yufang Lu, Inmagene's Chief Medical Officer, echoed these sentiments, emphasizing the potential for more robust efficacy with continuous treatment.

Aside from its application in atopic dermatitis, IMG-007 is being assessed for treating alopecia areata (AA). The final results for the AD study are expected in the third quarter of 2024, while initial data from the AA study are anticipated in the fourth quarter of 2024. Inmagene is also progressing other candidates in its pipeline, including IMG-004 and IMG-008, which target different mechanisms in immunological and inflammatory diseases.

Overall, the positive interim results from the Phase 2a trial of IMG-007 suggest a promising future for this treatment in addressing AD and potentially other related conditions.