Apogee Therapeutics shares rose 15% on Monday after the company disclosed positive 52-week results from Part A of its Phase 2 APEX trial evaluating zumilokibart (APG777) in people with moderate-to-severe atopic dermatitis.
The maintenance-phase data demonstrated durable clinical benefit through one year with both quarterly and biannual dosing schedules. Among patients who were responders at week 16, 75% of those on a three-month dosing interval and 85% of those on a six-month interval sustained an EASI-75 response at 52 weeks. Maintenance of investigator global assessment outcomes was also strong: 86% of week 16 responders on the three-month schedule and 78% on the six-month schedule retained vIGA 0/1 scores at one year.
Apogee reported that the degree of clinical improvement deepened across all lesional and itch endpoints among the full cohort originally randomized to zumilokibart, and that the agent was well tolerated. The company said the observed safety profile was generally consistent with other drugs in the same therapeutic class.
The 52-week maintenance evaluation tested a 360 mg dose of zumilokibart administered at either three-month or six-month intervals. The most commonly reported treatment-emergent adverse events were noninfective conjunctivitis, upper respiratory tract infection, and nasopharyngitis.
Looking ahead, Apogee expects to announce Part B 16-week induction data in the second quarter of 2026. Those results are expected to support the planned start of Phase 3 clinical trials in moderate-to-severe atopic dermatitis in the second half of 2026. If regulatory approvals are obtained, the company has communicated an expectation of a potential commercial launch in 2029.
The 52-week findings will be presented as a late-breaking oral presentation at the 2026 American Academy of Dermatology Annual Meeting on March 28.
Zumilokibart is an anti-IL-13 monoclonal antibody engineered to allow less frequent dosing than many current standard-of-care treatments for atopic dermatitis, which can require as many as 26 injections per year.
Key facts
- Shares rose 15% following the 52-week Part A maintenance data release.
- Among week 16 responders, 75% (3-month dosing) and 85% (6-month dosing) maintained EASI-75 at 52 weeks.
- Maintenance of vIGA 0/1 at 52 weeks was 86% for 3-month dosing and 78% for 6-month dosing.
Clinical and development timeline
- Maintenance portion used 360 mg doses at three- and six-month intervals.
- Part B 16-week induction data expected in Q2 2026.
- Phase 3 trials anticipated to begin in the second half of 2026, with a potential commercial launch in 2029 subject to regulatory approval.