Horizon Therapeutics:1st patient enrolled in Phase 2 daxdilimab trial for DLE

Horizon Therapeutics announced the first patient has enrolled in a Phase 2, randomized, placebo-controlled trial to evaluate its development-stage medicine daxdilimab, a potentially first-in-class, fully human monoclonal antibody targeting anti-ILT7 depletes certain dendritic cells to treat people with moderate-to-severe primary discoid lupus erythematosus, DLE . DLE is a rare, chronic, inflammatory skin condition characterized by lesions that result in scarring, irreversible hair loss and skin discoloration with no approved therapies. The localized form of primary DLE is characterized by limited cutaneous involvement of the head and scalp and usually accounts for 70% of primary DLE. The generalized form is characterized beyond this and includes the head-body area and usually accounts for about 30 percent of primary DLE. In the United States, approximately 30,000 patients with DLE are appropriate for treatment with novel therapies, including biologics.2 Primary DLE incidence rates are approximately four times higher among women compared with men and the disease has a higher prevalence among non-Latino Black and Latino populations. "DLE is one of the most challenging scarring skin diseases because there is no curative treatment. It causes round, inflammatory lesions that favor the scalp, face and ears and is associated with a diminished quality of life in patients," said Benjamin Chong, M.D., associate professor, department of dermatology, University of Texas Southwestern Medical Center. "There is a tremendous unmet medical need for safe treatments for DLE. This trial will help evaluate the potential of daxdilimab to meet this need."