Leo Pharma has shared phase 2b data on its eczema prospect temtokibart, reporting that the top three doses of the IL-22RA1 blocker beat placebo on the primary endpoint.
Temtokibart is designed to block IL-22, a cytokine implicated in eczema, and partially inhibit IL-20 and IL-24 signaling. The mechanism of action sets temtokibart apart from established eczema drugs such as Sanofi and Regeneron’s blockbuster immunology med Dupixent, which blocks IL-4 and IL-13, and JAK inhibitors including AbbVie’s Rinvoq. Leo linked temtokibart and Dupixent to comparable changes in eczema in a phase 2a trial.
The phase 2b trial compared four doses of temtokibart to placebo in 262 adults with moderate to severe atopic dermatitis, the most common type of eczema. Friday, Leo said the top three doses of temtokibart beat placebo on the primary endpoint, which tracked change in eczema area and severity over 16 weeks.
Leo is yet to share numbers from the trial. The only other details revealed in the top-line release relate to safety and tolerability. Leo said the treatment was generally well tolerated, with no dose dependency. Most adverse events were mild or moderate in severity and not considered related to treatment.
The Danish drugmaker is yet to discuss the next steps, only revealing that it is collecting and evaluating the full data set and will provide detailed results at a later date. Leo’s decisions about the candidate have implications for argenx, which discovered the candidate.
Argenx disclosed preclinical development of ARGX-112, the asset now called temtokibart, in 2013 and struck a deal with Leo two years later. Leo paid 4.5 million euros ($5 million) upfront. In 2022, Leo paid a further 5 million euros to take up its option on the candidate. Leo now has an exclusive global license, and argenx is eligible for up to 120 million euros in development, regulatory and commercial milestones.