Breakout Bulletin: May 3-8

You’re busy. Between patients, prior authorizations, and everything else on your plate, keeping up with the literature is the first thing that slips. Dermatology Times NP/PA Connect is here to make sure it doesn’t. Each week, we pull the most clinically relevant news from across dermatology and bring it straight to your inbox — what’s new, what it means, and what’s worth watching. This week: a new mechanism enters the hidradenitis suppurativa (HS) conversation, a nonsteroidal topical holds its ground at 6 months in steroid-refractory atopic dermatitis (AD), a promising approach to nodular basal cell carcinoma (BCC) that sidesteps surgery, and an early-stage melanoma immunotherapy worth putting on your radar.

HS Gets a New Mechanism — And It Held Up Where Others Have Struggled

Abdakibart, Avalo Therapeutics’ high-affinity IL-1β inhibitor, met its primary endpoint in the phase 2 LOTUS (NCT06603077) trial, achieving HiSCR75 in 42.2% and 42.9% of patients across both dosing arms at week 16, compared with 25.6% on placebo. The company reports these represent the highest absolute HiSCR75 improvements observed in trials of similar size or larger evaluating that endpoint — a notable benchmark in a disease where the bar keeps rising.¹

MORE ON HS

The mechanism is genuinely differentiated. Currently approved biologics for HS target TNF, IL-17, or IL-12/23. Abdakibart goes after IL-1β, a cytokine implicated in the early inflammatory cascade driving lesion formation and the chronic pain that defines HS for so many patients. Pain reduction — a secondary endpoint — was statistically significant, with meaningful proportions achieving at least a 30% reduction in patient-reported skin pain scores. That matters in a condition where pain is often the chief complaint walking through the door.

Equally important for the patient population APPs manage most: response rates were consistent regardless of prior biologic exposure. Biologic-experienced patients, typically the hardest to treat, responded similarly to biologic-naïve patients. The safety profile was clean across both arms, with no neutropenia, serious infections, or opportunistic infections — adverse events that carry particular weight in HS.

“Achieving this level of improvement suggests that IL-1β inhibition with abdakibart may offer a meaningful new therapeutic option for people with HS who continue to struggle with this disease. The physical and emotional burden of HS is profound.”— John Frew, PhD, University of New South Wales

Avalo plans to advance into a phase 3 registrational program. Full results are expected at an upcoming medical congress.

▶ Why it matters: Every patient with HS who cycles through existing biologics without adequate response is a patient waiting for something different. IL-1β inhibition has a mechanistic rationale and now a phase 2 signal to back it up.

MORE DRUGS TO WATCH

Ruxolitinib Cream Holds Its Response at 6 Months in the Patients Who Need It Most

New 24-week data from the phase 3b TRuE-AD4 (NCT06238817) trial add an important chapter to the ruxolitinib cream story: not only does it work at 8 weeks in adults with moderate AD who have failed or cannot tolerate topical corticosteroids and calcineurin inhibitors — it keeps working. Among patients who responded at week 8 and continued treatment, 84.3% maintained EASI-75 at week 24, essentially matching the 83.5% rate at week 8. IGA treatment success held at 70.6%, and affected BSA remained stable at a mean of 2.5% across both timepoints.²

The population enrolled in TRuE-AD4 is worth noting. These weren’t treatment-naive patients — they had documented inadequate response, intolerance, or contraindication to both TCS and TCI within the previous 12 months. Moderate AD affecting 10% to 20% BSA is a clinically significant disease burden, and this is precisely the group APPs see most in practice: patients who’ve maxed out their topical options and are staring down the question of what comes next. A topical JAK inhibitor that sustains response for 6 months in this group, with only 1.7% application site reactions and no new safety signals, gives practitioners a meaningful bridge option before escalating to systemic therapy.

Incyte has submitted a Type-II variation application in the EU for ruxolitinib cream 1.5% in adults with moderate AD. Regulatory feedback is expected in the first half of 2026.

▶ Why it matters: For steroid-refractory moderate AD, ruxolitinib cream now has 6-month durability data in a population that closely mirrors real-world practice. That’s a different conversation than 8-week trial data.

MORE ON AD

A Needle Array That Delivers Chemo Directly Into Basal Cell Carcinoma

Phase 2 expanded data for the doxorubicin microneedle array (D-MNA; Skinject) (NCT06608238) in nodular basal cell carcinoma showed a clear dose-dependent signal emerging by day 57, with the 200µg cohort achieving 64% clinical clearance and 55% histological complete response — compared with 29% clinical clearance in the device-only control arm at the same timepoint. The drug-treated arm continued to improve between day 29 and day 57, while the device-only arm did not, suggesting the therapeutic effect is biochemical rather than purely mechanical.³

The delivery mechanism is the story here. Microneedles deliver doxorubicin directly into the tumor microenvironment, bypassing the systemic toxicity profile that has historically made anthracyclines a non-starter in dermatology. No drug-related serious adverse events were observed, and no evidence of systemic doxorubicin toxicity was detected across either phase. Treatment-site reactions were mild and localized. For patients who are poor surgical candidates, who have recurrent lesions in cosmetically or functionally sensitive areas, or who simply want to explore a non-surgical path before committing to excision, this is a mechanistically novel option in development.

Medicus Pharma characterizes the expanded dataset as supportive of end-of-phase 2 FDA discussions, with the 200µg regimen as the lead dose. Sample sizes per arm are small, and registration-enabling studies will need to confirm the histological response signal at scale.

▶ Why it matters: Non-surgical, intralesional therapy for nodular BCC is a genuine unmet need for the right subset of patients. The histological response data at day 57 gives this program a credible path forward.

MORE ON SKIN CANCER

A Patient-Derived Immunotherapy for Melanoma Earns Fast Track — Here’s What That Actually Means

DOC1021, an autologous dendritic cell immunotherapy developed by Diakonos Oncology, has received FDA Fast Track designation for unresectable or metastatic cutaneous melanoma — its third Fast Track status across oncology indications, following pancreatic cancer and glioblastoma. A phase 1/2 (NCT07288112) trial in refractory melanoma is now actively enrolling.⁴

The mechanism is worth understanding. DOC1021 loads a patient’s own dendritic cells with both tumor-derived lysate and amplified tumor-derived mRNA from freshly obtained patient specimens — a dual-loading strategy designed to engage both MHC class I and class II pathways and drive a broader cytotoxic T-cell response against the tumor’s full antigen repertoire. Critically, it does not require lymphodepleting preconditioning chemotherapy or high-dose IL-2, 2 requirements that have historically narrowed patient eligibility for other cellular therapies. The platform is designed for outpatient delivery.

A clear-eyed read on where this sits: Fast Track designation reflects regulatory recognition of unmet need and early-stage promise — not clinical efficacy. No response data from the melanoma trial have been reported yet. Dendritic cell platforms have a complicated history, with mechanistic rationale often running ahead of reproducible clinical outcomes. The autologous manufacturing requirement introduces real-world variability that will need to be addressed as the program scales.

▶ Why it matters: For APPs in oncology-adjacent dermatology practices, understanding what Fast Track does and doesn’t mean is part of managing patient expectations. This one is worth watching, not yet acting on.

Looking for more recent news? Check out last week’s breakout bulletin!

References

1. Avalo Therapeutics achieves positive topline results in phase 2 LOTUS trial of abdakibart (AVTX-009) in moderate to severe hidradenitis suppurativa. News release. Avalo Therapeutics. Published May 5, 2026. Accessed May 7, 2026. https://www.globenewswire.com/news-release/2026/05/05/3288197/0/en/avalo-therapeutics-achieves-positive-topline-results-in-phase-2-lotus-trial-of-abdakibart-avtx-009-in-moderate-to-severe-hidradenitis-suppurativa.html?_gl=1*1q6dxyr*_up*MQ..*_ga*MTk0ODQyMzkwOS4xNzc4MDcyNzEx*_ga_B6167QB2TF*czE3NzgwNzI3MTAkbzEkZzAkdDE3NzgwNzI3MTAkajYwJGwwJGgxODUyMzEyMzU.*_ga_ERWPGTJ5X8*czE3NzgwNzI3MTAkbzEkZzAkdDE3NzgwNzI3MTAkajYwJGwwJGgw
2. Incyte Announces 24-Week Long-Term Data from Phase 3 TRuE-AD4 Trial of Opzelura® (ruxolitinib) Cream in Adults with Moderate Atopic Dermatitis. News release. Incyte. Published May 7, 2026. Accessed May 7, 2026. https://www.businesswire.com/news/home/20260507606978/en/Incyte-Announces-24-Week-Long-Term-Data-from-Phase-3-TRuE-AD4-Trial-of-Opzelura-ruxolitinib-Cream-in-Adults-with-Moderate-Atopic-Dermatitis
3. Medicus Pharma reports positive phase 2 SKNJCT-003 topline data observing 73% clinical clearance and 40% histological clearance (CR) at day 57 in 200μg cohort. News release. Medicus Pharma. Published March 5, 2026. Accessed May 7, 2026. https://medicuspharma.com/medicus-pharma-reports-positive-phase-2-sknjct-003-topline-data-observing-73-clinical-clearance-and-40-histological-clearance-cr-at-day-57-in-200g-cohort/
4. Diakonos Oncology awarded fast track designation by FDA for DOC1021 (dubodencel) in unresectable or metastatic cutaneous melanoma. News release. Diakonos. May 6, 2026. Accessed May 7, 2026. https://www.prnewswire.com/news-releases/diakonos-oncology-awarded-fast-track-designation-by-fda-for-doc1021-dubodencel-in-unresectable-or-metastatic-cutaneous-melanoma-302763752.html