Apogee Therapeutics announces interim Phase 1 results for APG333

Apogee Therapeutics (APGE) announced interim Phase 1 results from its first-in-human study of APG333, which demonstrated data supporting potential 3- and 6-month dosing based on a half-life of approximately 55 days across doses tested. Additionally, APG333 was well tolerated across all cohorts, with doses up to 1,000 mg. The APG333 Phase 1 clinical trial was designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose study in healthy volunteers. It evaluated the safety, tolerability and PK of APG333 in 32 healthy adults across four cohorts. Key results include: APG333 demonstrated an optimized PK profile, including a half-life of approximately 55 days, supporting potential for APG273 every 3-month or better dosing. Key biomarkers of eosinophils and IL-5 showed depth of suppression in line with TSLP analogs and durability out to 6 months. APG333 was well tolerated across the four cohorts, with doses of up to 1,000 mg. The most common treatment-emergent adverse events occurring in greater than or equal to10% of APG333 treated participants were headache and upper respiratory tract infection. TEAEs were generally mild and self-limited and there were no dose dependent trends in TEAEs seen. There were no Grade 3 TEAEs related to study drug or serious adverse events. No adverse events led to study discontinuation. “We are encouraged by these initial results, which further highlight the potential of TSLP inhibition, a clinically validated target that plays an important role in promoting immune cell recruitment and activation,” said Carl Dambkowski, CMO. “APG333’s PK profile supports the potential for dosing two to four times a year, a significant advancement over the current standard of care. These data unlock our combination of APG777 and APG333, which together demonstrated suppression of complementary pathways implicated in obstructive airway disease and may enable quarterly or less frequent dosing, expanding options for patients with limited available treatments.”