EADV Releases Nemolizumab Phase 2 Data

Nemolizumab phase 2 clinical trial data for patients with prurigo nodularis and atopic dermatitis was recently released at the EADV.

Galderma announced the presentation of new phase 2 data supporting the efficacy of nemolizumab at the virtual 30th annual European Academy of Dermatology and Venereology (EADV) congress.1

Nemolizumab is a humanized monoclonal antibody created to block signaling from the IL-31 receptor.

Results from 2 key trials of nemolizumab treatment every 4 weeks demonstrate rapid effectiveness and significant reduction in symptoms for patients with prurigo nodularis (PN) and atopic dermatitis (AD), and new evidence that highlights PN disease burden.

"We are delighted to share new analyses and clinical trial data which reinforce nemolizumab’s therapeutic potential and comprehensive benefits across prurigo nodularis and atopic dermatitis,” said Baldo Scassellati Sforzolini, global head of R&D, Galderma, Far Hills, New Jersey. “The scientific evidence for the critical role that the IL-31 pathway plays in the inflammatory process is growing and we are committed to continuing our work diligently to bring nemolizumab to patients living with these debilitating skin conditions.” 

Nemolizumab significantly reduces itch in PN

Data from a secondary analysis of the phase 2 trial evaluating the onset of action in itch and sleep disturbance in patients with moderate to severe PN was revealed. Within 48 hours, nemolizumab had significantly reduced severe itch over 3 times more effectively than placebo (-19.5% vs -5.8%, respectively, p = .014) and decrease in itch, which was maintained for the duration of the study. 

At day 4, approximately one fourth of patients were already demonstrating strong reduction in severe itch responses to treatment with nemolizumab, compared to no responses for the placebo group (23.5% vs 0%, p < .001) and at 12 weeks, over 50% of PN patients demonstrated a response to nemolizumab treatment (52.9% vs. 8.3%). Also, nemolizumab led to a 4 times greater improvement in sleep disturbance vs placebo at day 4 (-19.8% vs -4.3%, p = .012), with continued improvement through week 4.

"Prurigo nodularis is associated with a markedly impaired quality of life [QoL] and frequent sleep deprivation,” said Sonja Ständer, MD, lead study investigator, professor for dermatology, University Hospital Muenster, Germany. “This analysis highlights nemolizumab’s rapid onset of action bringing itch reduction within 48 hours of the first dose, and a significant improvement in sleep as early as day 4 for moderately to severely affected patients. This symptomatic relief translates into a meaningful improvement in day-to-day life for these patients.

Direct anti-inflammatory effect suggested for nemolizumab leading to early improvement in AD

New and consistent findings for nemolizumab in AD were also presented from a secondary post-hoc analysis of the phase 2b data in adult patients with moderate to severe AD, according to the press release. 

Nemolizumab demonstrated a significant improvement in the clinical signs and symptoms of AD at week 1 of treatment, as indicated by scoring AD (SCORAD), which increased through week 16. This included early improvement of erythema and excoriation, suggesting a direct anti-inflammatory effect, whereas improved skin dryness vs placebo could be a consequence of a beneficial effect of nemolizumab on the skin barrier, the release explained.

"This analysis is important as it points to the direct anti-inflammatory effect of nemolizumab and builds our understanding of its mechanism of action bringing rapid and profound reduction in itch sensations and skin lesions for patients living with atopic dermatitis,” said Jean-David Bouaziz, lead investigator, Department of Dermatology, Saint-Louis Hospital, France.

Improvement in signs and symptoms of AD in adolescent patients

A third abstract considered the pharmacokinetics (PK), safety, and efficacy during nemolizumab treatment of AD in adolescent patients. In patients aged 12-17 with moderate to severe pruritus, nemolizumab achieved an improvement in rash, itch, sleep and QoL, and biomarkers.

This is an update to earlier data released in April 2021. 

Reference:

Galderma presents new nemolizumab data at EADV reinforcing rapid onset of action and consistent relief of symptoms for people with prurigo nodularis and atopic dermatitis. Galderma. Press release. Published September 29, 2021. Accessed October 8, 2021. https://www.galderma.com/news/galderma-presents-new-nemolizumab-data-eadv-reinforcing-rapid-onset-action-and-consistent