Apogee Therapeutics Reports Positive 16-Week APEX Trial Data for APG777.

Apogee Therapeutics announced positive 16-week data from the Phase 2 APEX clinical trial of APG777, its anti-IL-13 antibody, in moderate-to-severe atopic dermatitis. The trial met all primary and key secondary endpoints, including a 71.0% decrease in EASI from baseline at Week 16. APG777 demonstrated an EASI-75 of 66.9% (42.5% placebo-adjusted) at Week 16, the highest topline and placebo-adjusted efficacy of any biologic in a global study. APEX Part B will test higher exposures with readout accelerated and anticipated mid-2026, enabling Phase 3 initiation in 2026.

Apogee Therapeutics (NASDAQ: APGE) has announced positive 16-week data from the Phase 2 APEX clinical trial of APG777, its anti-IL-13 antibody, in patients with moderate-to-severe atopic dermatitis. The trial achieved all primary and key secondary endpoints, including a 71.0% decrease in EASI (Eczema Area Severity Index) from baseline at Week 16 [1].

APG777 demonstrated an EASI-75 response rate of 66.9% (42.5% placebo-adjusted) at Week 16, representing the highest topline and placebo-adjusted efficacy of any biologic in a global study to date [1]. This impressive result underscores APG777's potential as a best-in-class treatment for moderate-to-severe atopic dermatitis.

The trial also observed a significant exposure-response relationship, with patients in the highest exposure quartile achieving remarkable EASI-75 responses of 89.5%, and similarly impressive vIGA 0/1 and EASI-90 rates of 63.2% [1]. This finding supports Apogee's strategy to test higher exposures in APEX Part B, which is now projected to readout in mid-2026 [1].

APG777 was well-tolerated with a favorable safety profile, consistent with other agents in the IL-13 inhibitor class. The drug showed rapid onset of itch relief and a low rate of serious treatment-emergent adverse events (TEAEs) [1]. Additionally, the treatment led to a significant reduction in injection days compared to current biologics, with only four injection days needed in the 16-week induction period [1].

The positive results from APEX Part A de-risk Apogee's lead program and validate their platform for developing extended half-life biologics with reduced dosing frequency. The company plans to initiate Phase 3 trials in 2026, further enhancing the potential of APG777 [1].

References:
[1] https://www.stocktitan.net/news/APGE/apogee-therapeutics-announces-positive-16-week-data-from-phase-2-wzqq2y2io5vu.html