Inmagene Biopharmaceuticals has announced encouraging results from a Phase 2a clinical trial evaluating the use of IMG-007 for the treatment of moderate-to-severe atopic dermatitis (AD). The study, which included both short- and long-term assessments, showed significant improvements in patients’ eczema area and severity index (EASI), with a 77% reduction in EASI scores after 4 weeks of treatment. By 16 weeks, 54% of patients achieved an EASI-75 response.
Phase 2a Trial Highlights
The Phase 2a open-label study (NCT05984784) involved 13 adult patients with moderate-to-severe atopic dermatitis at clinical centers in Canada and the United States. IMG-007, a nondepleting anti-OX40 monoclonal antibody (mAb), was administered intravenously in three doses at 0, 2, and 4 weeks. The treatment was well-tolerated, and the results aligned with previous data released by Inmagene.
After four weeks of treatment, patients experienced a substantial improvement in their EASI scores, with a mean reduction of 77%. By 16 weeks, 54% of patients achieved an EASI-75 response, indicating a significant reduction in eczema severity. These outcomes were comparable to other investigational OX40-targeting therapies, which also demonstrate prolonged effects.
Further analysis revealed that IMG-007 treatment led to durable inhibition of serum inflammatory markers across various T helper (Th) cells, including Th1, Th2, and Th17 cells, for up to 24 weeks. Importantly, no adverse events resulted in treatment discontinuation, and there were no serious treatment-related events. Notably, no instances of pyrexia or chills were reported among participants.
Subcutaneous Formulation and Phase 1 Trial
In a separate Phase 1 trial (NCT06304740), Inmagene also evaluated the subcutaneous formulation of IMG-007 in 16 healthy adult subjects. The pharmacokinetic profile of the subcutaneous form was consistent with that of the intravenous version, with a notably long terminal half-life of 34.7 days. This extended half-life is significantly longer than other OX40/OX40L-targeting mAbs in clinical development.
The subcutaneous formulation of IMG-007 was well-tolerated, with the most common adverse events being injection site reactions. Interestingly, these reactions were more frequent in the placebo group (75%) compared to those receiving IMG-007 (25%). The safety profile of the subcutaneous formulation suggests that it could offer a promising option for long-term management of atopic dermatitis.
A Potential Game Changer for Atopic Dermatitis
Atopic dermatitis is a chronic, relapsing condition that requires ongoing management. Currently, approved biologics for AD require frequent injections, typically every two to four weeks. The extended half-life of IMG-007’s subcutaneous formulation, combined with its favorable safety profile, could provide patients with an alternative that requires fewer injections.
Dr. Yufang Lu, Chief Medical Officer at Inmagene, expressed optimism about the trial results, noting the potential for IMG-007 to offer a differentiated dosing regimen for long-term treatment of atopic dermatitis. “The robust observed clinical activity and biomarker data, coupled with the well-tolerated safety profile, suggest that IMG-007 has retained the desired biological activity of OX40 blockade while improving tolerability,” said Dr. Lu.
As Inmagene continues to investigate the potential of IMG-007, these promising Phase 2a and Phase 1 findings may bring new hope to patients with moderate-to-severe atopic dermatitis, offering them more effective and convenient treatment options.
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