LEO Pharma has reported positive topline outcomes from the randomised Phase IIb trial of the IL-22 receptor subunit alpha 1 (IL-22RA1) antagonist temtokibart, a potential new treatment for the adult population with moderate-to-severe atopic dermatitis (AD).
This multi-site, parallel-group, placebo-controlled, dose-finding, double-blind trial is designed to assess the safety and efficacy of the therapy’s different doses, administered subcutaneously in this patient group.
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The trial achieved positive outcomes in its primary endpoint, showing a significant percentage change in the Eczema Area and Severity Index (EASI) from baseline to week 16 for the three highest doses.
LEO Pharma noted that the treatment was tolerated well, with the majority of adverse events being non-serious and of mild or moderate severity.
Subjects in the trial were randomised and given one of four doses of the therapy or a placebo.
The key secondary endpoint included the number of treatment-emergent adverse events per patient from baseline to week 16.
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By GlobalDataLEO Pharma Science, Search & Innovation executive vice-president and chief scientific officer Dr Jacob Pontoppidan Thyssen said: “LEO Pharma is committed to making a fundamental difference for these patients, and we are encouraged by the results of this phase IIb trial, which has explored how to target the disease from a different angle with a different mechanism of action, compared to what is commonly used today to treat AD.
“These results further add to the understanding of the mode of action of temtokibart and its potential abilities to address unmet needs in diseases where the IL-22 pathway is known to play a key role – in medical dermatology and beyond.”
The investigational monoclonal antibody, temtokibart, also referred to as LEO 138559, works by blocking the impact of the interleukin-22 cytokine, which is said to be elevated in AD patients.
LEO Pharma and immunology company argenx formed a strategic partnership since 2015, focusing on developing antibody-based solutions for treating chronic inflammation. Through this research agreement, temtokibart was co-developed, and LEO has secured the exclusive licence to develop and commercialise the treatment.
In May last year, LEO Pharma reported positive data from the Phase III trial of Enstilar in Chinese adult patients with stable plaque psoriasis.
