Leo Pharma Reports Positive Phase 2b Results for Eczema Drug Temtokibart

Leo Pharma has announced promising results from its phase 2b clinical trial of temtokibart, a novel treatment for moderate to severe atopic dermatitis, the most common form of eczema. The study, which evaluated four doses of the IL-22RA1 blocker against placebo, demonstrated significant improvements in eczema symptoms for patients receiving the top three doses.

Trial Design and Primary Endpoint Success

The phase 2b trial enrolled 262 adult patients with moderate to severe atopic dermatitis. Participants were randomized to receive one of four doses of temtokibart or placebo. The primary endpoint of the study measured the change in eczema area and severity over a 16-week treatment period.

According to Leo Pharma, the top three doses of temtokibart achieved statistically significant improvements compared to placebo on the primary endpoint. While specific numerical data have not yet been disclosed, the company reported that the results were positive and aligned with their expectations.

Safety Profile and Tolerability

Temtokibart demonstrated a favorable safety and tolerability profile in the phase 2b study. Leo Pharma stated that the treatment was generally well-tolerated across all dose groups, with no apparent dose-dependent adverse effects. The majority of reported adverse events were classified as mild to moderate in severity and were not considered to be related to the study drug.

Mechanism of Action and Market Positioning

Temtokibart represents a potentially innovative approach to treating atopic dermatitis. The drug is designed to block IL-22, a cytokine implicated in the pathogenesis of eczema, while also partially inhibiting IL-20 and IL-24 signaling. This mechanism of action distinguishes temtokibart from currently approved treatments such as Sanofi and Regeneron's Dupixent, which targets IL-4 and IL-13, and JAK inhibitors like AbbVie's Rinvoq.

In a previous phase 2a trial, Leo Pharma reported that temtokibart demonstrated comparable efficacy to Dupixent in improving eczema symptoms. These latest phase 2b results further support the potential of temtokibart as a competitive option in the growing atopic dermatitis market.

Development History and Future Plans

Temtokibart, originally known as ARGX-112, was initially discovered by argenx. In 2015, Leo Pharma acquired the rights to the compound, paying an upfront fee of 4.5 million euros. The Danish pharmaceutical company later exercised its option on the candidate in 2022 with an additional payment of 5 million euros, securing an exclusive global license.

Under the terms of their agreement, argenx remains eligible for up to 120 million euros in development, regulatory, and commercial milestones related to temtokibart's progress.

Leo Pharma has not yet disclosed specific plans for the next stages of temtokibart's development. The company stated that it is currently evaluating the full data set from the phase 2b trial and will provide more detailed results at a future date. The success of this study is likely to inform decisions regarding potential phase 3 trials and regulatory submissions.