⚡First ITK Blocker in Atopic Dermatitis

Good morning — it’s Saturday, May 24, and we’re covering soquelitinib, a first-in-class ITK inhibitor for atopic dermatitis, new trial results for icotrokinra in high-impact psoriasis sites, and more.

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Corvus Pharmaceuticals’ soquelitinib emerged as a promising candidate for moderate to severe atopic dermatitis, demonstrating rapid and deep responses in an early-stage trial. Results from the randomized Phase 1 study were presented at the SID 2025 Annual Meeting.

Soquelitinib is an oral inhibitor of interleukin-2–inducible T cell kinase (ITK), which modulates T cell differentiation by suppressing Th2/Th17 pathways and promoting Th1 responses.

Investigators randomized 44 patients who had failed at least one prior topical or systemic therapy to receive either soquelitinib or placebo.

Among patients receiving the highest dose (200 mg BID), 63% achieved at least a 75% reduction in disease severity (EASI-75) after just 28-days, and 25% reached clear or near-clear skin (IGA 0/1). No patients in the placebo group achieved these outcomes. Notably, clinical separation was observed as early as Day 8.

The combined soquelitinib arms were significantly superior to placebo (P = 0.03), despite the short treatment window and more severe baseline disease in the high-dose group. Clinical responses persisted 30 days after treatment discontinuation.

Serum biomarker analysis revealed reduced levels of IL-17, IL-31, TSLP, and other cytokines, alongside increases in T-regulatory cells.

Soquelitinib was well tolerated, with comparable adverse event rates between groups.

A Phase 2 trial is anticipated later this year. The drug’s novel ITK inhibition may also prove useful in other immune-mediated diseases.

> Icotrokinra Clears High-Impact Psoriasis Sites: In the Phase 3 ICONIC-TOTAL trial, Johnson & Johnson’s icotrokinra—a first-in-class oral IL-23 receptor antagonist—demonstrated high clearance rates in patients with psoriasis affecting high-impact skin sites. These difficult-to-treat areas significantly impair daily function and quality of life. Investigators randomized 311 participants with at least moderate psoriasis affecting high-impact sites to icotrokinra or placebo. At Week 16, 66% of patients with scalp involvement achieved clear or almost clear skin (ss-IGA 0/1) compared to 11% on placebo. Clearance rates were also high for genital psoriasis (77% vs. 21%) and hand/foot disease (42% vs. 26%). No new safety signals emerged, confirming a favorable risk profile.

> Tapinarof Delivers High Clearance and Enables Treatment Free Periods in Atopic Dermatitis: Results from the 48-week ADORING 3 open-label extension trial highlight tapinarof’s ability to achieve high skin clearance and sustain disease control during treatment-free intervals in atopic dermatitis. Among 728 participants aged 2 years and older, 52% achieved complete clearance (vIGA-AD 0) and 82% reached clear or almost clear skin (vIGA-AD 0/1) at least once during the study. Patients who achieved full clearance discontinued treatment and were monitored until disease recurrence (vIGA-AD ≥2). The mean treatment-free interval following initial clearance was 80 days, though this may be underestimated due to trial end truncation. Notably, patients whose disease worsened after stopping treatment recaptured full clearance upon retreatment. The safety profile was consistent with earlier trials. Adverse events of special interest were mild and included follicular events (14%), headache (4%), and contact dermatitis (<1%). Limitations include the open-label design and potential overrepresentation of prior responders. Watch how tapinarof works here.

> Biomarker Test Guides Biologic Selection and Improves Psoriasis Outcomes: Mind.Px, a machine learning–based transcriptomic test, guided biologic treatment decisions in a 16-week randomized trial of patients with moderate-to-severe psoriasis. The test gathers transcriptomic data from lesional skin via a minimally invasive dermal patch and predicts response to TNFα, IL-17, or IL-23 inhibitors. Of 310 patients screened, 210 completed the study and were randomized to a Mind.Px-guided arm or a usual care arm without test results. Physician concordance—defined as prescribing a biologic that matched the test result—was 93% in the informed group versus 65% in the uninformed group (P < 0.000001). The high concordance indicates physicians were willing to use test results to guide prescribing. Among 143 patients with complete efficacy data, 82% in the informed group achieved at least a 75% reduction in severity (PASI75) at week 12, compared to 54% in the uninformed group (P < 0.001). Despite dropout, the findings suggest transcriptomic guidance may reduce trial-and-error prescribing, improving outcomes and potentially lowering costs.

> First Data for QRX003 in Peeling Skin Syndrome Suggest Clinical Benefit: Quoin Pharmaceuticals reported encouraging interim results from its first pediatric patient treated with QRX003 lotion for generalized peeling skin syndrome (PSS). The rare autosomal recessive genodermatosis—caused by mutations in the corneodesmosin gene—leads to severe skin peeling, pain, and itch. QRX003 contains a serine protease inhibitor that compensates for the underlying protein loss. After 12 weeks of treatment, the patient experienced a two-grade improvement on the Investigator’s Global Assessment (IGA), from severe to mild, and a reduction in the Modified Ichthyosis Area Severity Index (M-IASI) score from 36 to 12 (scale: 0–48). The Children’s Dermatology Life Quality Index (CDLQI) improved from 19 to 11. Treatment was well tolerated, and the patient will continue the lotion for at least 24 weeks. QRX003 is also in development for Netherton Syndrome, with initial findings reported earlier this year showing similarly promising outcomes.

> Modest Gains With Linerixibat For Itch Due To Primary Biliary Cholangitis: In the Phase 3 GLISTEN trial, GSK’s ileal bile acid transporter (IBAT) inhibitor linerixibat modestly reduced cholestatic pruritus in adults with primary biliary cholangitis (PBC) and moderate-to-severe itch. Among 238 participants, 56% of patients on linerixibat achieved a ≥3-point reduction in itch severity on the Worst Itch Numeric Rating Scale (WI-NRS, range 0–10) by Week 24, compared to 43% on placebo (P = 0.04). The drug also improved itch-related sleep interference scores. Diarrhea was the most common adverse event, leading to treatment discontinuation in 4% of patients versus less than 1% in the placebo group. Linerixibat blocks bile acid reuptake in the ileum, reducing systemic pruritogenic mediators. While the efficacy gains were modest, the absence of approved therapies for PBC-associated itch underscores the clinical relevance of these findings.

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