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This interview highlights topline findings from Part B of the phase 2 APEX trial highlight the efficacy of zumilokibart (APG777) in adults with atopic dermatitis.
In a recent interview with the HCPLive team, Ruth Ann Vleugels, MD, MPH, MBA, spoke about her team’s newly released APEX Part B results assessing the use of investigational IL-13 inhibitor zumilokibart (APG777) in adults with moderate-to-severe atopic dermatitis, noting what she described as notably strong efficacy results paired with a familiar and reassuring safety profile.
In her discussion, Vleugels said the data stood out not only because the study attained its primary endpoint of EASI-75 at the 16-week mark, but because several higher-threshold efficacy measures exceeded investigators’ expectations. She pointed specifically to the rates of EASI-90 and Investigator’s Global Assessment (IGA) 0/1 responses, noting that the numerical improvements appeared meaningfully higher than those seen historically with currently available biologic agents for atopic dermatitis. Vleugels also emphasized that earlier findings with the therapy suggest responses may continue to deepen beyond the initial 16-week induction period.
“[We] know from previous data that even past the initial 16 weeks there's additional improvement on this therapy, so the efficacy data is quite robust and exciting to those of us who take care of patients with atopic dermatitis,” she explained.
One of the most clinically meaningful findings, according to Vleugels, was the proportion of patients achieving very low disease activity (vLDA), a composite endpoint incorporating both skin clearance and itch control. Vleugels noted many individuals classified as treatment successes under traditional endpoints still experience residual symptoms, particularly pruritus, underscoring why clinicians increasingly view more stringent disease-control targets as needed.
Vleugels contrasted these outcomes with the efficacy profile of JAK inhibitors, which she acknowledged can achieve similarly high-level responses but may create hesitation among some clinicians because of boxed safety warnings involving cardiovascular events, malignancy, and thrombosis risk. In that context, she said a biologic capable of reaching comparable efficacy benchmarks could represent an important advancement for clinicians seeking highly effective options with a more established safety profile.
Regarding tolerability, Vleugels noted that the adverse event (AE) profile observed with zumilokibart aligned with prior experience using IL-4 and IL-13 pathway inhibitors. She characterized conjunctivitis, the most discussed adverse event in this therapeutic class, as generally manageable, often mild, and rarely severe enough to require discontinuation.
She also highlighted the therapy’s reduced injection frequency as a potentially important differentiator. According to Vleugels, maintenance dosing as infrequently as 2 to 4 times annually could substantially lessen treatment burden compared with currently available biologics, something she said patients consistently value in clinical practice.
Disclosures: Vleugels has previously reported serving as a principal investigator and/or consultant for Pfizer, AstraZeneca, Apogee, Priovant, BMS, Lilly, and Johnson & Johnson.
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