Pharmaceutical Market Europe • June 2025 • 10-11
DERMATOLOGY NEWS
J&J/Protagonist’s icotrokinra shows promise in psoriasis
Johnson & Johnson (J&J) and Protagonist Therapeutics’ investigational oral peptide icotrokinra (JNJ-2113) has been associated with significant skin clearance in patients with difficult-to-treat psoriasis, according to new data from a late-stage study of the candidate.
The ICONIC-TOTAL trial has been evaluating the drug in adults and adolescents aged 12 years and older with at least moderate plaque psoriasis affecting high-impact skin sites.
Results presented at this year’s Society for Investigative Dermatology annual meeting demonstrated that 57% of patients receiving once-daily icotrokinra achieved an Investigator’s Global Assessment (IGA) score of zero or one (clear or almost clear skin) and at least a two-grade improvement from baseline at week 16, compared to 6% of patients receiving placebo.
Among patients with scalp psoriasis, 66% achieved a scalp-specific IGA score of zero or one compared to 11% receiving placebo at week 16, while 77% of icotrokinra-treated genital psoriasis patients achieved a static Physician’s Global Assessment of Genitalia score of zero or one versus 21% of those in the placebo cohort at the same time point.
A higher rate of skin clearance was also seen in patients with hand/foot psoriasis.
GSK shares phase 3 data for linerixibat in PBC-related itch
GSK has shared promising results from a late-stage study of its investigational oral ileal bile acid transporter inhibitor linerixibat in patients with primary biliary cholangitis (PBC) and cholestatic pruritus.
The phase 3 GLISTEN trial has been evaluating the candidate in adults with the rare autoimmune liver disease and cholestatic pruritus, or relentless itch, a key symptom of the condition that can cause sleep disturbance, fatigue and impaired quality of life.
Results presented at this year’s European Association for the Study of the Liver Congress demonstrated that linerixibat significantly improved itch compared to placebo over 24 weeks, meeting the trial’s primary endpoint. Patients randomised to receive linerixibat experienced an average placebo-adjusted improvement of 0.72 points on a ten-point rating scale for the worst itch (WI-NRS).
Key secondary endpoints were achieved, with significant itch improvements seen as early as week two. GSK’s drug also led to significant benefits in itch-related sleep interference, and 56% of linerixibat-treated patients achieved clinically meaningful itch improvement, defined as at least a three point reduction on the WI-NRS, compared to 43% in the placebo group at week 24.
Dermaliq and DEBRA enter epidermolysis bullosa partnership
Dermaliq Therapeutics and global non-profit organisation DEBRA Research have entered into a partnership aimed at advancing drug delivery into the skin for epidermolysis bullosa (EB).
The non-exclusive collaboration will initially focus on enhancing wound-healing and anti-itch therapies, as well as developing prophylactic therapies for patients with the group of rare and painful genetic skin disorders.
Approximately 500,000 people worldwide are affected by EB, which causes the skin to become extremely fragile, and blister and tear very easily. The disorders currently have no cure, and treatments are limited to relieving symptoms and preventing complications such as infection.
Dermaliq’s hyliQ technology allows for the targeted delivery of active compounds into the skin without mechanical interference to fragile or wounded tissue.
The touchless approach is specifically designed for conditions like EB and offers “critical therapeutic benefits” for patients by delivering treatments while preserving the integrity of compromised skin, the partners said.
Though financial details of the alliance have not been disclosed, the new partners outlined that DEBRA will make a strategic investment in Dermaliq as part of the agreement.
FDA approves Arcutis’ Zoryve foam for plaque psoriasis
The US Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ once-daily steroid-free foam Zoryve (roflumilast) 0.3% to treat plaque psoriasis of the scalp and body in adults and paediatric patients aged 12 years and older.
Almost nine million people in the US are affected by some form of psoriasis, a chronic inflammatory skin disease, and nearly half of patients experience scalp involvement.
Arcutis’ Zoryve foam is designed to inhibit the action of phosphodiesterase-4, an established target in dermatology, and has already been approved by the FDA to treat seborrhoeic dermatitis. Cream formulations of Zoryve have also been approved in the US to treat plaque psoriasis and atopic dermatitis.
Among the clinical evidence supporting the FDA’s latest decision were results from the phase 3 ARRECTOR study, which showed that 66.4% of patients treated with Zoryve foam achieved Scalp-Investigator Global Assessment (IGA) success at week eight, compared to 27.8% of patients treated with a matching vehicle foam.
Additionally, 45.5% of Zoryve-treated patients achieved Body-IGA success at the same time point, compared to 20.1% of those receiving a matching vehicle foam.
Almirall highlights psychological burden of skin diseases
Almirall has unveiled study results highlighting the psychological burden of skin diseases and the positive impact treatments have on patient well-being.
The company presented its work in psychodermatology at this year’s Congress of the European Society for Dermatology and Psychiatry, as well as the inaugural World Psychodermatology Congress.
Results from POSITIVE, the first real-world study in dermatology to assess patients’ psychological well-being as a primary endpoint using the five-item World Health Organization Well-being Index, showed that the majority of patients with moderate-to-severe psoriasis experienced improvements in both skin symptoms and psychological well-being within 16 weeks of treatment.
However, there was a delay in psychological improvement compared to skin improvement in approximately 10% of patients in POSITIVE, and some experienced persistent psychological distress despite achieving significant improvements in skin clearance.
Data from the PRO-SCALP study in mild-to-moderate scalp psoriasis and the phase 3b ADvantage trial in moderate-to-severe atopic dermatitis also demonstrated significant improvements in patient well-being with treatment.
Almirall said that, by using these patient-centred endpoints, clinicians could better understand the wider effects of skin conditions and their treatments.
LEO to evaluate delgocitinib cream in palmoplantar pustulosis
LEO Pharma has announced that it has initiated a phase 2a study of its delgocitinib cream in adults with palmoplantar pustulosis (PPP).
The proof-of-concept DELTA NEXT trial will compare the safety and efficacy of the pan-Janus kinase (JAK) inhibitor against cream vehicle in patients with mild-to-severe PPP for whom topical corticosteroids are inadequate or inadvisable.
There are currently no advanced systemic treatments approved in Europe or the US for PPP, an uncommon inflammatory skin disease that primarily affects women between the ages of 40 and 69 years.
The condition is characterised by repeated episodes of sterile pustules on the palms, soles of the feet, or both. Patients may also experience erythema, blistering and scaly skin, as well as pain and fatigue.
LEO’s Anzupgo is designed to inhibit the activity of all four JAKs, which are involved in inflammatory signalling, and already holds approvals to treat certain cases of chronic hand eczema.
DELTA NEXT will aim to recruit up to 135 patients across 40 to 45 sites in the UK, US, Canada, Germany and Poland.
Pharmaceutical Market Europe (PME)
Pharmaceutical industry news, articles, jobs, reports, advice and services