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Apogee Therapeutics (Nasdaq: APGE), a clinical-stage biotech based in San Francisco and Boston, reported 52-week maintenance data from the Phase II APEX Part A trial of zumilokibart (APG777) in moderate-to-severe atopic dermatitis, with results showing that patients maintained and deepened clinical responses on dosing schedules of every three or six months. If confirmed in placebo-controlled and Phase III studies, the zumilokibart atopic dermatitis data could position the anti-IL-13 antibody as a less frequently dosed alternative to current biologics that require injections as often as every two weeks. Trial specifics The APEX trial is a Phase II study evaluating zumilokibart at 360mg administered subcutaneously at three- and six-month intervals in adults with moderate-to-severe atopic dermatitis. Part A assessed maintenance of response over 52 weeks among patients who had completed a 16-week induction period. Among patients who achieved response at Week 16, 75% and 85% maintained EASI-75 — a 75% or greater reduction in the Eczema Area and Severity Index — with every three-month and every six-month dosing, respectively. Maintenance of clear or almost clear skin, measured by validated Investigator’s Global Assessment (vIGA) scores of 0 or 1, was observed in 86% of patients on three-month dosing and 78% on six-month dosing. The company also reported that deepening of response occurred across all lesional and itch endpoints in the full population of patients initially randomized to zumilokibart, not solely among Week 16 responders. The EASI-75 zumilokibart results, together with the vIGA data, form the core of the efficacy case the company is building ahead of Phase III. Zumilokibart was well tolerated across both dosing regimens over the full 52-week study period. The most common treatment-emergent adverse events were noninfective conjunctivitis, upper respiratory tract infection, and nasopharyngitis — a profile the company described as generally consistent with other agents in the IL-13 inhibitor class. Mechanism and drug context Zumilokibart is a subcutaneous monoclonal antibody engineered with an extended half-life that targets interleukin-13, a cytokine considered a primary driver of the inflammation, barrier dysfunction, and pruritus characteristic of atopic dermatitis. According to the company, zumilokibart achieves greater than 99% inhibition of IL-13, which Apogee Therapeutics argues underpins the rapid onset and sustained depth of response observed in the APEX trial atopic dermatitis data. The extended half-life engineering is what enables the three- and six-month dosing intervals that distinguish the Apogee Therapeutics APG777 program from existing biologics in the class. The moderate-to-severe atopic dermatitis treatment landscape has expanded in recent years with the approval of dupilumab (Dupixent), an anti-IL-4 receptor alpha antibody administered every two weeks; tralokinumab (Adbry), an anti-IL-13 antibody dosed every two weeks during induction and every two to four weeks thereafter; and oral JAK inhibitors including upadacitinib (Rinvoq) and abrocitinib (Cibinqo). Dupilumab remains the most widely prescribed biologic in the indication. Tralokinumab is the most direct comparator for zumilokibart given their shared IL-13 target. In its pivotal trials, tralokinumab demonstrated EASI-75 rates of approximately 25–33% at Week 16 versus placebo rates of around 10–13%, with maintenance dosing every two weeks or every four weeks. The zumilokibart maintenance data — showing 75–85% of Week 16 responders maintaining EASI-75 at 52 weeks on three- or six-month dosing — appear numerically distinct in terms of dosing frequency, though cross-trial comparisons are limited by differences in study design, patient populations, and the absence of a placebo arm in the APEX Part A maintenance phase. The Part A data represent a responder-enriched population, which inflates absolute response rates relative to intent-to-treat analyses from pivotal trials. The dosing interval is the central differentiator. Current standard-of-care biologics require between 13 and 26 injections per year. If zumilokibart’s efficacy and safety are confirmed in controlled studies, a regimen of two to four doses per year would represent a meaningful reduction in treatment burden. Whether this translates into improved adherence and real-world outcomes remains to be determined. What next for the APEX trial APEX Part B, a placebo-controlled dose optimization segment that randomized 347 patients 1:1:1:1 to high-, medium-, or low-dose zumilokibart versus placebo, is expected to report 16-week induction data in the second quarter of 2026. That readout will provide the first controlled efficacy comparison for the molecule in atopic dermatitis and will be a more informative test of zumilokibart’s treatment effect size relative to placebo. Based on the Part A and anticipated Part B results, Apogee plans to initiate Phase III trials of zumilokibart in moderate-to-severe atopic dermatitis in the second half of 2026, with a potential commercial launch targeted for 2029. The 52-week data will be presented in a late-breaking oral presentation at the 2026 American Academy of Dermatology Annual Meeting on March 28 in Denver. The company has also disclosed plans to expand zumilokibart’s development into asthma, eosinophilic esophagitis, and other inflammatory and immunology indications, though timelines for those programs were not specified in the current disclosure. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Eli Lilly announced positive Phase III results for Ebglyss (lebrikizumab-lbkz) in pediatric patients aged six months to 18 years with moderate-to-severe atopic dermatitis. The ADorable-1 trial met both co-primary endpoints at Week 16, generating the first Phase III dataset for a selective IL-13 inhibitor in children as young as six months, a population with limited approved systemic treatment options. ADorable-1 (NCT05559359) is a randomized, double-blind, placebo-controlled Phase III study that enrolled 363 pediatric participants with moderate-to-severe atopic dermatitis. Patients were randomized to receive placebo or weight-based doses of lebrikizumab. All participants used topical corticosteroids beginning two weeks before randomization and throughout the 16-week treatment period, though tapering was permitted once patients reached an Investigator’s Global Assessment score of 2 or less. At Week 16, 63% of lebrikizumab-treated patients achieved EASI-75, compared with 22% on placebo. For the second co-primary endpoint, 44% of lebrikizumab-treated patients achieved IGA 0 or 1 with a reduction of at least 2 points from baseline, versus 15% on placebo. Among key secondary endpoints, 39% of patients on lebrikizumab reached EASI-90 compared with 11% on placebo, and 35% of patients aged six years and older achieved a Pruritus NRS improvement of at least 4 points, versus 6% on placebo. The company did not disclose p-values or confidence intervals in its topline announcement. The safety profile was consistent with that observed in adult and adolescent studies, the company said, with no new signals identified. Upper respiratory tract infections and nasopharyngitis were the most common adverse events occurring in 5% or more of participants, with no numerical imbalance between arms. No injection site pain was reported in either group. Lilly stated it plans to submit these data to the US FDA and other global regulators to support a potential label expansion into younger pediatric populations. The ADorable program continues, with results from ADorable-2, a 52-week extension study of ADorable-1 participants, expected later this year. EBGLYSS received US FDA approval in 2024 for adults and children aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis not adequately controlled by topical prescription therapies. The drug was approved in the EU in 2023 and in Japan and Canada in 2024. Lebrikizumab is a monoclonal antibody that binds soluble IL-13 at a site overlapping with the IL-4Rα binding region on the IL-13Rα1/IL-4Rα receptor complex, preventing receptor assembly and downstream signaling. IL-13 is considered a central driver of type 2 inflammation in atopic dermatitis, contributing to skin barrier dysfunction, epidermal thickening, pruritus, and susceptibility to infection. By selectively neutralizing IL-13 without blocking IL-4, lebrikizumab differs mechanistically from dupilumab, which targets the shared IL-4Rα subunit used by both cytokines. Atopic dermatitis affects an estimated 9.6 million children in the United States, according to the company, with roughly one-third experiencing moderate-to-severe disease. Treatment options for younger children remain more limited than those available to adults and adolescents. Topical corticosteroids and calcineurin inhibitors remain first-line therapy, while systemic options have expanded in recent years for older patients. The ADorable-1 data, if they support regulatory approval, could extend the labeled use of lebrikizumab to patients as young as six months. Key competitors include: Sanofi and Regeneron’s dupilumab, an IL-4Rα antagonist that received US FDA approval for children aged six months to five years with moderate-to-severe atopic dermatitis in 2022, making it the first biologic approved for this age group. LEO Pharma’s tralokinumab, another IL-13 inhibitor approved for adults, with ongoing Phase 3 pediatric studies. AbbVie’s upadacitinib, an oral JAK1 inhibitor approved for adults and adolescents with moderate-to-severe atopic dermatitis, with pediatric studies underway. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website