Apogee Therapeutics (NASDAQ:APGE) released positive Phase 2 APEX trial results for APG777, its anti-IL-13 antibody for moderate-to-severe atopic dermatitis.
The trial met its primary endpoint with a 71% reduction in Eczema Area Severity Index (EASI) score at Week 16, versus 33.8% for placebo.
APG777 achieved an EASI-75 response rate of 66.9%, the highest topline and placebo-adjusted efficacy for any biologic in a global atopic dermatitis study to date, according to the company.
The drug’s safety profile was consistent with other agents in the class.
As a result, the company is accelerating its timeline for Part B results, which are testing higher doses, to mid-2026. It also plans to initiate a Phase 3 trial in 2026.
“Today’s results from APEX Part A demonstrate strong efficacy results across all key endpoints,” Apogee's chief medical officer Dr Carl Dambkowski said in a statement.
“In addition to these potentially best-in-class results, increased response rates were observed in patients with higher exposures, supporting our exposure-response hypothesis which we continue to further test in APEX Part B.”
Shares of Apogee fell nearly 15% following the results, possibly driven by profit-taking and high market expectations.