Apogee Therapeutics has reported positive interim results from a Phase 1 trial evaluating APG990, a subcutaneous, extended half-life monoclonal antibody targeting OX40L, for inflammatory and immunological conditions such as atopic dermatitis (AD), according to a press release.
Researchers for the double-blind, placebo-controlled study enrolled 40 healthy adult participants across five cohorts. Participants received single ascending doses of APG990. Primary endpoints assessing safety, tolerability, and pharmacokinetics. APG990 was well-tolerated and no serious adverse events reported, according to the interim data.
Pharmacokinetic analysis indicated AGP990 showed a terminal half-life of approximately 60 days, supporting the potential for maintenance dosing every three to six months. The mechanism, according to the manufacturer, positions APG990 as a potential treatment option for patients who do not respond adequately to existing therapies targeting IL-4Rα or IL-13 pathways. Apogee plans to advance its pipeline with a combination therapy, APG279, which includes APG990 and APG777, an anti-IL-13 monoclonal antibody, to target complementary inflammatory pathways.
“The interim results as well as the supportive preclinical combination toxicology studies are an important step forward in our combination plans for the program, suggesting strong potential for compatibility with APG777 and supporting our planned APG777 and APG990 coformulated combination approach, which we have named APG279," he said in a press release from the manufacturer. "With the potential to broadly inhibit Type 1, Type 2 and Type 3 inflammation, APG279 could offer patients a more effective treatment option, while minimizing side effects seen with other available therapies. Based on these findings, we plan to initiate a head-to-head Phase 1b trial of the combination against DUPIXENT this year.”
Source: Apogee Therapeutics press release. March 3, 2025.