⚡New Long Acting IL13 Antibody for Eczema

Good morning — it’s Saturday, July 12, and we’re covering a novel anti–IL-13 antibody in atopic dermatitis, the first prospective psoriasis trial across all skin tones, and more.

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Apogee Therapeutics has announced compelling results from Part A of the Phase 2 APEX trial evaluating APG777 in moderate-to-severe atopic dermatitis.

APG777 is a novel high-affinity anti–IL-13 antibody designed with an extended half-life to potentially enable less frequent dosing.

The study randomized 123 patients to receive the investigational drug or placebo, using an induction regimen of four injections over 16 weeks.

At Week 16, 67% of APG777-treated patients achieved at least a 75% improvement in disease severity (EASI 75), compared to 25% on placebo (P < 0.001). According to Apogee, both the absolute and placebo-adjusted EASI 75 rates are the highest reported for any biologic in a global atopic dermatitis trial to date.

Investigators noted a clear exposure–response relationship, with 90% of patients in the highest exposure quartile reaching EASI-75. APEX Part B is now testing higher doses aligned with this top quartile, with results anticipated in mid-2026.

Treatment was generally well tolerated. The most common adverse events (≥5%) included noninfective conjunctivitis (15%), upper respiratory tract infection (9%), and nasopharyngitis (5%).

APEX Part A will now enter its maintenance phase through Week 52, evaluating potential best-in-class extended dosing intervals of every 3 or 6 months.

Apogee is also advancing APG279, a combination of APG777 and an OX40L inhibitor (APG990), with a head-to-head trial against dupilumab currently underway.

> Guselkumab clears psoriasis and reduces pigmentation burden across skin tones in the VISIBLE trial: The IL-23 inhibitor guselkumab (Tremfya) demonstrated high efficacy in patients with moderate-to-severe psoriasis and skin of color, according to the Phase 3b VISIBLE trial published in JAMA Dermatology. Investigators randomized 103 participants to guselkumab or placebo, with placebo patients crossing over to guselkumab at Week 16. Nearly 70% of enrolled patients had Fitzpatrick skin types IV–VI. At Week 16, 74% of guselkumab-treated patients achieved clear or almost clear skin (IGA 0/1) compared to 0% on placebo (P < 0.001). Improvements were sustained through Week 48, with more than 70% maintaining IGA 0/1 responses. Guselkumab also improved pigmentation-related quality of life. SDIEQ scores (a 0–15 scale measuring pigmentation-specific quality of life) fell from 9.6 to 2.7 (–6.9 points) versus 8.9 to 6.5 (–2.4 points) with placebo (P < 0.001), marking a shift from moderate to mild pigmentation burden. Safety findings were consistent with the drug’s known profile. VISIBLE is the first prospective, randomized trial in moderate-to-severe psoriasis to include participants across the full spectrum of objectively measured skin tones.

> Zelsuvmi launches in the US as first at-home treatment for molluscum contagiosum: Pelthos Therapeutics has launched berdazimer (Zelsuvmi) topical gel 10.3%, the first and only FDA-approved at-home treatment for molluscum contagiosum. The approval was based on the B-SIMPLE program, a trio of Phase 3 randomized trials comprising the largest interventional cohort of patients with molluscum contagiosum studied to date. The integrated analysis, published in JAAD in 2024, included 1,598 participants. At Week 12, 30% of patients using once-daily berdazimer achieved complete clearance, compared to 20% with vehicle (P < 0.001). The gel was well tolerated, with application-site pain (19%) and erythema (12%) reported as the most common adverse events. Berdazimer is a first-in-class topical antiviral that is coadministered with a hydrogel (proton donor) to activate nitric oxide release at the site of application. Nitric oxide exerts broad-spectrum antimicrobial and antiviral activity.

> First study to define dermoscopic features of early nail melanoma during follow-up of longitudinal melanonychia: A multicenter European study is the first to characterize dermoscopic changes during serial follow-up of longitudinal melanonychia that may indicate early nail matrix melanoma. Sixty-two adults with a single acquired pigmented nail band underwent serial digital dermoscopy. Lesions were either excised for histologic diagnosis or monitored for at least one year to confirm clinical and dermoscopic stability. After a median of 17 months, 27 lesions were biopsied: 6 were diagnosed as in situ melanomas. At baseline, no significant differences were found between benign and malignant lesions, highlighting the diagnostic uncertainty in early-stage disease. However, during follow-up three dermoscopic features were significantly associated with melanoma: increased pigmentation intensity (83% vs. 14%; P = 0.001), emergence of granular pigmentation (33% vs. 4%; P = 0.04), and an increased number of colors (50% vs. 9%; P = 0.02). Limitations include the small number of melanoma cases, multiple statistical comparisons, and an all-Caucasian cohort. The findings suggest that sequential digital dermoscopy follow-up may help guide biopsy decisions when baseline features are inconclusive. Key dermoscopic images are available in the article (paywall restricted).

> Linperlisib–chidamide combination may offer synergy in refractory CTCL: A Phase 1 nonrandomized trial published in JAMA Dermatology suggests that combining linperlisib, a selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, with chidamide, a histone deacetylase (HDAC) inhibitor, may offer synergistic activity in relapsed or refractory cutaneous T-cell lymphoma (CTCL). PI3K inhibitors suppress tumor growth by modulating intracellular signaling cascades, while HDAC inhibitors may restore tumor-suppressive signaling by reversing epigenetic dysregulation. The study enrolled 22 patients (median of three prior systemic therapies) in dose-escalation and expansion phases. No dose-limiting toxicities occurred, and linperlisib at 80 mg was selected for further study. The objective response rate was 59% (95% CI, 39–77%), including 2 complete and 11 partial responses. Most adverse events were mild (Grade 1 or 2), with nausea, pruritus, and rash reported most frequently. Grade 3 events occurred in 23% of patients, but no Grade 4 or 5 events were reported. Compared to lower monotherapy response rates reported in the literature (40% for linperlisib and 23–36% for chidamide), these findings may point to potential synergy. However, interpretation is limited by the small sample size, nonrandomized design, and short follow-up (median, 8.9 months).

Quizzes, cases, and perspectives to sharpen your clinical eye.

In the Danish BABY cohort of 245 infants (180 term, 65 preterm), the presence of hyperlinear palms at 2 months was associated with an increased risk of developing atopic dermatitis by age 1, independent of filaggrin gene mutation status (adjusted HR 2.13; 95% CI: 1.08–4.20). Among term infants, the combination of hyperlinear palms and elevated TARC/CCL17—a type 2 inflammation marker—further increased the risk by age 2 (HR 5.59; 95% CI: 1.69–18.51) (More)

LEO Pharma’s IL-13 inhibitor tralokinumab (Adtralza) met all Week 16 efficacy endpoints in the ADHAND Phase 3b trial of adults with moderate-to-severe atopic dermatitis of the hands who are candidates for systemic therapy. Detailed results from this interim analysis will be released later (More)

Upadacitinib 15 mg daily combined with 308-nm excimer laser twice weekly over four months reduced the Vitiligo Area Scoring Index (VASI) by 58% and the SCORing Atopic Dermatitis (SCORAD) score by 42% in 19 patients with refractory vitiligo and moderate-to-severe atopic dermatitis; the face and neck showed over 70% reduction in vitiligo severity (More)

All 64 patients treated for neck rejuvenation with a next-generation 1550-nm nonablative laser using focal point technology achieved >50% improvement, with 54% showing 76–100% improvement. No adverse events occurred beyond mild, transient erythema and edema (More)

In a retrospective study of 384 keloids treated with excision and radiotherapy, heterotopic ossification identified on histology—present in 10% of cases—was significantly associated with a higher postoperative recurrence rate (33% vs. 15%, P = 0.009), suggesting it may serve as a biomarker of recurrence risk (More)