⚡New HS Pill, HPV Vaccine for AKs, and Acne LED Devices

Good morning. It's Saturday, Mar. 22, and we're covering povorcitinib in hidradenitis suppurativa, HPV vaccination for actinic keratosis, at-home LED acne devices, and more.

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Need To Know

Povorcitinib Nears FDA Submission for Hidradenitis Suppurativa

Povorcitinib, Incyte’s oral small-molecule JAK1 inhibitor, met key primary endpoints in the Phase 3 STOP-HS1 and STOP-HS2 trials for moderate to severe hidradenitis suppurativa.

Investigators randomized approximately 1,200 patients to receive either povorcitinib or placebo. By week 12, 40–42% of patients on povorcitinib achieved HiSCR50, defined as at least a 50% reduction in abscess and nodule counts with no worsening in abscesses or draining tunnels. In comparison, 29–30% of patients on placebo met the same threshold.

Notably, povorcitinib showed greater efficacy in patients previously treated with biologics: 34–45% achieved HiSCR50 versus 20–22% on placebo.

Patients treated with povorcitinib also reported meaningful improvements in skin pain and fewer disease flares. Safety results aligned with previous studies, revealing no new concerns.

On the back of these results, Incyte plans to seek regulatory approval. If approved, povorcitinib would offer an oral alternative with a novel mechanism of action.

Despite the clinical success, Incyte’s stock fell nearly 9%, reflecting concerns the drug may be best suited for biologic non-responders.

Gardasil-9 Reduces Actinic Keratosis Burden

The standard 9-valent HPV vaccine (Gardasil-9) unexpectedly reduced actinic keratosis burden in adults with extensive disease, according to results from the VAXAK trial published in JAMA Dermatology.

In the trial, 70 patients with 15 or more actinic keratoses within an area of 50–100 cm² were randomized to receive either the HPV vaccine or saline injections at months 0, 2, and 6. Thick lesions received cryotherapy at months 6 and 9.

By month 12, the vaccinated group had a 58% reduction in lesion count versus 41% in the sham group (P = 0.03). Vaccinated patients also had significantly fewer total lesions (median: 10 vs 16) and thick lesions (median: 3 vs 5).

In contrast, rates of new actinic keratoses and keratinocyte carcinomas were similar between the two groups at month 12. Adverse events were mild.

The authors suggest that HPV vaccination may serve as an adjunct—not a replacement—to conventional actinic keratosis therapy in patients with a high disease burden.

They propose the vaccine’s effect may be mediated by nonspecific immune activation, cross-reactivity between α- and β-HPV types, and enhanced T-cell responses targeting keratinocytes with elevated viral antigen expression.

Quick Hits

> At-Home LED Devices Effective For Acne: A JAMA Dermatology meta-analysis found that at-home LED devices significantly reduce acne lesions compared to control treatments in patients with mild to moderate acne. Investigators analyzed six randomized trials with 216 participants. Compared to control, LED devices resulted in a 45 percentage point greater improvement in inflammatory lesions and a 48 percentage point greater improvement in noninflammatory lesions. Among different wavelengths, both red and blue light were effective, with combination therapy demonstrating greater efficacy than blue light alone in one study. Adverse effects were mild, including erythema, dryness, and discomfort. No severe reactions were reported.

> FDA Finds Most Benzoyl Peroxide Acne Products Pose Low Benzene Risk: Following concerns raised by a third-party lab report, the FDA tested 95 benzoyl peroxide-based acne products, finding that over 90% contained undetectable or very low levels of benzene. Six products with elevated levels are being voluntarily recalled at the retail level, but not the consumer level. The agency emphasized that even with daily use over decades the cancer risk from these products remains very low. The FDA also cautioned that testing methods used by some third-party laboratories may overestimate contamination, underscoring the need for validated approaches when assessing product safety.

> TYK2 Rival ICP-488 Advances to Phase 3: InnoCare presented strong data from a Phase 2 trial evaluating ICP-488, a potent and selective oral tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate to severe psoriasis. At week 12, 79% of patients receiving the 9 mg dose achieved at least a 75% reduction in psoriasis severity (PASI 75), compared to just 12% receiving placebo. Patients also experienced deeper clearance, with 50% achieving PASI 90. The drug demonstrated good tolerability, with only mild to moderate adverse events reported. InnoCare also announced this week that the first patient has been dosed in its Phase 3 trial evaluating ICP-488 for psoriasis.

> Microneedle Patch Clears Basal Cell Carcinoma in Early Study: Medicus announced positive interim Phase 2 results for its transdermal patch designed to treat basal cell carcinoma. The patch uses dissolvable microneedle arrays tip-loaded with doxorubicin, a chemotherapeutic agent. In this ongoing 60-patient trial, an analysis of patients treated to date showed that over 60% achieved complete clinical clearance. No serious adverse events were reported. Medicus plans to submit the findings to the FDA, seeking to fast-track the clinical development of this novel non-invasive therapeutic platform.

> Apogee Targets Twice-Yearly Dosing in Atopic Dermatitis: Apogee Therapeutics reported favorable Phase 1 results for APG990, a novel monoclonal antibody targeting OX40L. In 40 healthy participants, the drug showed an extended half-life of around 60 days and no severe adverse events. The pharmacokinetic profile suggests APG990 could enable maintenance dosing for atopic dermatitis as infrequently as every three to six months. Apogee plans to combine APG990 with APG777, a half-life extended IL-13 monoclonal antibody, to enhance efficacy. A Phase 1b head-to-head trial comparing the combination to Dupixent for moderate to severe atopic dermatitis is set to begin this year.

> QRX003 Lotion for Netherton Syndrome: Quoin’s QRX003 lotion has shown encouraging early results in the first pediatric patient to receive whole-body treatment for Netherton Syndrome. After just two weeks of application, the patient experienced near-complete skin healing, discontinued all previous medications, and had uninterrupted sleep for the first time. The patient experienced no adverse events. QRX003 contains a serine protease inhibitor that mimics the function of LEKTI, a protein lacking in Netherton Syndrome.

> Remibrutinib Effective in Chronic Spontaneous Urticaria: Results from the REMIX-1 and REMIX-2 Phase 3 trials, published in The New England Journal of Medicine, highlight remibrutinib’s superiority over placebo in chronic spontaneous urticaria (CSU). Among 925 patients with CSU unresponsive to second-generation H1-antihistamines, 52–55% of those receiving remibrutinib achieved well-controlled disease (UAS7 ≤6) at 24 weeks, compared to 28–35% receiving placebo (p<0.001). Notably, 36% of remibrutinib-treated patients had complete symptom resolution (UAS7=0) by 24 weeks. The drug’s safety profile was favorable, though petechiae were more common with remibrutinib (3.8% vs. 0.3%). Remibrutinib, a Bruton tyrosine kinase inhibitor, blocks mast cell and basophil degranulation downstream of the high-affinity IgE receptor (FcεRI), preventing the release of histamine and other proinflammatory mediators. 

> Ivarmacitinib’s Pros & Cons in Severe Alopecia Areata: Jiangsu Hengrui’s JAK1 inhibitor ivarmacitinib showed notable hair regrowth in a Phase 3 trial of adults with severe alopecia areata (≥50% scalp hair loss). Among 330 randomized patients, 41% of those receiving ivarmacitinib 8 mg and 35% receiving 4 mg reached at least 80% scalp hair coverage (SALT score ≤20) at week 24, compared to 9% on placebo. However, adverse events were slightly more common in the 8 mg group. Isolated cases of follicular lymphoma and thyroid cancer were also reported in the ivarmacitinib arms.

> Bimekizumab Shows Five-Year Durability in Psoriasis: At AAD 2025, UCB announced five-year results from its open-label extension trial of bimekizumab (Bimzelx), a dual IL-17A/IL-17F inhibitor, for moderate to severe psoriasis. Among 153 patients completing five years of treatment, PASI 100 response rates—indicating complete skin clearance—were 75% at Year 1 and 68% at Year 5. Response rates remained high regardless of weight, cardiometabolic comorbidities, and baseline risk for psoriatic arthritis. No new safety concerns emerged during the study period.

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