Leo Achieves Primary Endpoint for Eczema in Phase 2b Trial of Ex-Argenx Asset

Danish pharmaceutical company Leo Pharma has announced results from a phase 2b clinical trial involving its promising eczema treatment, temtokibart. The drug is engineered to block IL-22, a cytokine involved in eczema, while also partially inhibiting IL-20 and IL-24 signaling. This mode of action distinguishes temtokibart from existing eczema medications, such as Sanofi and Regeneron's Dupixent, which targets IL-4 and IL-13, and JAK inhibitors like AbbVie's Rinvoq.

In the phase 2b study, temtokibart was administered in four different doses to 262 adults diagnosed with moderate to severe atopic dermatitis, which is the most prevalent form of eczema. Leo Pharma reported that the three highest doses of temtokibart achieved better results than a placebo in terms of the primary endpoint. This endpoint focused on the change in eczema severity and the affected area over a 16-week period. However, Leo has not yet disclosed specific numerical data from the trial. In terms of safety, the treatment was generally well-tolerated, with most adverse events being mild or moderate, and no significant correlation with the dosage levels was observed.

The Danish company has not yet outlined its plans for the next steps in developing temtokibart. Presently, Leo is in the process of collecting and evaluating the complete dataset from the trial and intends to release comprehensive results at a future date. These forthcoming decisions are particularly significant for argenx, the biotechnology company that originally discovered temtokibart, then known as ARGX-112, during its preclinical development phase back in 2013. Two years later, argenx entered into an agreement with Leo Pharma. Under this agreement, Leo paid an initial fee of 4.5 million euros (approximately $5 million) and, in 2022, paid an additional 5 million euros to exercise its option on the drug candidate. Leo now holds an exclusive global license to temtokibart, while argenx stands to gain up to 120 million euros through various developmental, regulatory, and commercial milestones, should the treatment continue to progress successfully.

This potential breakthrough is particularly noteworthy because of the distinct mechanism of temtokibart compared to other eczema treatments. Traditional therapies often focus on different cytokines and have varying efficacy and side effect profiles. The success of temtokibart in these early trials could pave the way for a new class of eczema treatments that might offer alternatives for patients who do not respond adequately to existing therapies.

As the medical community awaits detailed results from Leo Pharma, the future of temtokibart remains a point of interest, especially given the competitive landscape of eczema treatments. The outcome of this drug’s development will not only impact Leo but also have financial and strategic implications for argenx, highlighting the interconnected nature of pharmaceutical innovation and partnerships.