Sanofi and Regeneron have received a positive opinion from CHMP for Dupixent (dupilumab) for chronic spontaneous urticaria (CSU), recommending the treatment for adults and adolescents aged 12 years and older.

CSU is an inflammatory skin disease characterised by the sudden onset of hives and itching. It is partly driven by type 2 inflammation. Current therapies typically target histamine-1 (H1) receptors to control symptoms, but the condition remains uncontrolled despite H1 antihistamine (H1AH) treatments.

The recommendation applies to patients with moderate to severe disease who have had an inadequate response to H1AH and who are naïve to anti-immunoglobulin E (IgE) therapy. It follows results from two phase 3 trials in the LIBERTY-CUPID programme (studies A and C), which demonstrated a statistically significant reduction in itch and hives at 24 weeks versus placebo.

A third study (study B) assessed Dupixent’s safety in a different patient population. Adverse events were more frequent in the treatment group compared with placebo, although findings were consistent with the established safety profile.

UCB has reported positive early clinical trial results for galvokimig, an investigational therapy for adults with moderate-to-severe atopic dermatitis (AD). Findings from the phase 1/2a study were presented at the European Academy of Dermatology and Venereology Congress in Paris, France.

At week 12, 64.9% of patients receiving galvokimig achieved at least a 75% improvement in skin lesions, compared with 12.3% in the placebo group. Nearly half reached a 90% improvement, versus 3.5% for placebo. After 18 weeks, the most common treatment-emergent side effects included rhinitis, nasopharyngitis, headache, dizziness and throat pain.

Galvokimig is a multi-specific antibody therapy designed to target three inflammatory proteins implicated in the chronic inflammation of AD. By inhibiting both Th2 and Th17 pathways, researchers hope it can address the disease’s complex immune mechanisms and improve treatment outcomes.

Atopic dermatitis affects between 2% and 10% of adults worldwide and is associated with significant impacts on quality of life. UCB confirmed that a phase 2b trial is expected to begin by the end of 2025.

InflaRx – a biopharmaceutical company developing anti-inflammatory therapeutics targeting the complement system – has announced positive topline data from its phase 2a basket study evaluating INF904 as a potential treatment for hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU).

HS and CSU are chronic inflammatory skin conditions characterised by rashes, abscesses, inflammation and scarring.

INF904 is an orally administered, small molecule inhibitor of the C5a receptor (C5aR1) that has demonstrated anti-inflammatory activity across several preclinical disease models.  According to InflaRx, pharmacokinetic and pharmacodynamic data support the candidate’s best-in-class potential for blocking C5a-induced neutrophil activation.

The safety and efficacy of INF904 are being assessed in two multicentre, open-label phase 2a studies, each exploring multiple dosing regimens over a four-week treatment period.

Topline results from both studies indicated treatment efficacy across patient cohorts, with InflaRx reporting improvements in clinical scores for 29 out of 31 HS patients and 30 out of 31 CSU patients.

Camilla Chong, Chief Medical Officer of InflaRx, commented: “Results from our phase 2a study indicate INF904’s positive safety profile to date and show promising signals of clinical benefit in both hidradenitis suppurativa and chronic spontaneous urticaria.”