RAPT Therapeutics announces initiation of first-in-human phase 1 study of RPT193

RAPT is developing RPT193 initially for the treatment of atopic dermatitis, and subsequently plans to expand clinical development into allergic asthma and other allergic inflammatory diseases.

“The onset of atopic dermatitis often occurs during childhood and can persist into adulthood,” commented Emma Guttmann-Yassky, M.D., Ph.D., of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York. “The estimated U.S. adult prevalence of atopic dermatitis is seven percent of adults, with 20-30% of these having disease characterized as moderate to severe. There is a true need for a safe and effective oral therapeutic to address this growing need.”

RAPT’s Phase 1 study of RPT193 is enrolling both healthy volunteers and patients with moderate to severe atopic dermatitis at multiple sites in North America and Europe. Initial cohorts of healthy volunteers in the Phase 1a single ascending dose portion of the study were dosed with RPT193 or placebo beginning in August. Preliminary safety, pharmacokinetic and pharmacodynamic data to date from these initial cohorts supports once-daily oral dosing with RPT193 and dose escalation continues as planned. After completing the Phase 1a single and multiple ascending dose cohorts of healthy volunteers, RAPT will enroll the Phase 1b double-blind, placebo-controlled portion of the study in patients with moderate to severe atopic dermatitis (AD). The endpoints of the Phase 1b study include safety, pharmacokinetics, and exploratory endpoints including biomarkers and efficacy as evaluated by multiple measurements, including the Eczema Area and Severity Index (EASI). Preclinical studies of RPT193 demonstrated its ability to block the migration of mouse and human Th2 cells in vitro as well as inhibit inflammation in models of atopic dermatitis and asthma.

“Building on our preclinical results, we anticipate clinical proof-of-concept results from the Phase 1b portion of our RPT193 study by mid-2020, and if positive, we intend to continue further development in atopic dermatitis and expand our clinical development into additional Th2-driven allergic indications such as allergic asthma, chronic rhinosinusitis, eosinophilic esophagitis, skin rash and conjunctivitis,” said Brian Wong, M.D., Ph.D., president and CEO of RAPT Therapeutics.

Source: Company Press Release