Apogee Therapeutics’ anti-IL-13 antibody has been tied to a 71% reduction in eczema severity after 16 weeks, hitting the main goal of a phase 2 trial.
The mid-stage study saw 123 adults with moderate-to-severe atopic dermatitis (AD) receive either a placebo or a 720-mg dose injection of the candidate, dubbed APG777, at the start of the trial and then at week 2, followed by a 360 mg dose at both weeks 4 and 12.
Patients who received APG777 reported a mean reduction in their Eczema Area Severity Index (EASI) score of 71% compared to 33.8% in the placebo cohort, hitting the study’s primary endpoint.
A total of 66.9% of patients who received the anti-IL-13 antibody saw a 75% or greater increase in their EASI score, compared to 24.6% of those on placebo, Apogee added in the July 7 release. The Waltham, Massachusetts-based biotech declared this the “highest absolute and placebo-adjusted EASI-75 of any biologic.”
While trial-to-trial comparisons should be treated with caution, Dupixent—Regeneron and Sanofi’s blockbuster AD drug that also inhibits IL-13—has been tied to a 51% rate of EASI-75 at week 16.
Apogee CEO Michael Henderson, M.D., said the results showed APG777 “has the potential to set a new standard of care by offering improved clinical responses with transformational quarterly or better maintenance dosing.”
Investors appeared to agree, sending the company’s stock up 20% to $56.96 in pre-market trading Monday from a Thursday closing price of $47.46.
Some of the other secondary endpoints were “in line with standard of care,” according to Apogee, including the 33.9% of APG777 patients who saw a 90% or greater improvement in their EASI score compared to the 14.7% of the placebo group.
Patients who received the antibody treatment saw a “statistically significant” 50.7% reduction in itchiness after the first week compared to 23.2% of the placebo group, the company added.
APG777 had a safety profile “consistent with other agents in the class,” according to Apogee, which pointed to 1.2% of patients receiving APG777 who experienced a serious treatment-emergent adverse events (TAES) compared to 2.4% of the placebo group.
The most common TEAEs were non-infectious conjunctivitis, upper respiratory tract infection, and nasopharyngitis.
The second part of the phase 2 study, which is expected to kick off in mid-2026 and have 280 patients, will test higher exposures of the drug. A phase 3 trial is also pencilled in for next year.
“Today’s results from APEX Part A demonstrate strong efficacy results across all key endpoints,” Apogee’s Chief Medical Officer Carl Dambkowski, M.D., said in the release. “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.”
“Combined with a favorable safety profile, these findings reinforce APG777’s potential to deliver meaningful and durable benefits to patients while significantly reducing dosing frequency compared with existing agents,” Dambkowski added.
Apogee spun out of Paragon Therapeutics in 2022, before going public the following year. The biotech has previously set out plans to launch a head-to-head trial this year comparing Dupixent to a combination of APG777 and Apogee’s OX40L-targeting monoclonal antibody APG990.