Apogee's Anti-IL-13 Antibody Shows Promise in Phase 2 Eczema Trial

Apogee Therapeutics has announced promising results from a phase 2 trial of its anti-IL-13 antibody, APG777, for the treatment of moderate-to-severe atopic dermatitis (AD). The study's findings suggest that APG777 could potentially set a new standard in eczema treatment, with impressive efficacy and a favorable dosing schedule.

Impressive Efficacy Results

In the phase 2 trial involving 123 adult patients, APG777 demonstrated significant improvements in eczema severity. Patients receiving the antibody treatment experienced a mean reduction of 71% in their Eczema Area Severity Index (EASI) score after 16 weeks, compared to a 33.8% reduction in the placebo group. This marked improvement met the study's primary endpoint.

Furthermore, 66.9% of patients treated with APG777 achieved a 75% or greater improvement in their EASI score (EASI-75), compared to 24.6% in the placebo group. Apogee claims this is the "highest absolute and placebo-adjusted EASI-75 of any biologic" in the field.

The treatment also showed rapid efficacy in reducing itchiness, with APG777-treated patients experiencing a statistically significant 50.7% reduction after just one week, compared to 23.2% in the placebo group.

Dosing Schedule and Safety Profile

APG777 was administered as a 720-mg dose injection at the start of the trial and at week 2, followed by 360 mg doses at weeks 4 and 12. This dosing regimen suggests the potential for quarterly or less frequent maintenance dosing, which could offer a significant advantage over existing treatments.

The safety profile of APG777 was reported to be consistent with other agents in its class. Only 1.2% of patients receiving APG777 experienced serious treatment-emergent adverse events (TEAEs), compared to 2.4% in the placebo group. The most common TEAEs were non-infectious conjunctivitis, upper respiratory tract infection, and nasopharyngitis.

Future Developments and Market Implications

Apogee is planning to initiate the second part of the phase 2 study in mid-2026, which will involve 280 patients and test higher exposures of the drug. A phase 3 trial is also scheduled for next year. Additionally, the company has previously announced plans to launch a head-to-head trial comparing APG777 in combination with their OX40L-targeting monoclonal antibody APG990 against Dupixent, the current market leader in AD treatment.

The announcement of these results has had a significant impact on Apogee's stock, with shares rising 20% in pre-market trading following the news. As the company continues to develop APG777, it aims to establish a new standard of care in the treatment of atopic dermatitis, potentially challenging the dominance of existing therapies in this lucrative market.