629 Evaluating the safety and efficacy of topical KM-001, a TRPV3 inhibitor, for treatment of pruritus in patients with Lichen Simplex Chronicus (LSC): A first in human, double-blind, randomized vehicle-controlled study

Kamari is performing a clinical trial (KM001-AB1) evaluating the safety and efficacy of KM001, novel topical TRPV3 inhibitor, in patients with moderate to severe pruritus caused by LSC. cation channel highly expressed keratinocytes affecting proliferation, differentiation inflammation processes can be activated various distinctive triggers. It was implicated pathogenesis chronic related diseases such as atopic Dermatitis. The study taking place Germany, multicenter enrolling 51 treated for 4-weeks. Eligible demonstrate pruritis (PPNRS score ≥7) are diagnosed LSC at least 8 weeks. randomly assigned one 3 arms: 0.3% or 1% vehicle only control. primary endpoint tolerability, including AE reporting, vital signs, ECG laboratory assessments. Efficacy endpoints include changes severity scale) investigator global assessment (IGA). KM001's systemic exposure will characterized through PK sampling. This first randomized, double-blind, vehicle-controlled assess KM001 treatment patients. Its design allow thorough ability reduce pruritus, well characterizing its plasma exposure. A sentinel group has completed without any serious treatment-emergent adverse events. Topline results expected during Q2 2023.