Kiniksa presents Phase 1a/1b data for KPL-716 in atopic dermatitis
Kiniksa Pharmaceuticals presented Phase 1a/1b clinical data for KPL-716, an investigational fully-human monoclonal antibody that targets oncostatin M receptor beta, at the 27th European Academy of Dermatology and Venereology Congress. In this First-in-Human clinical trial, single intravenous and subcutaneous doses of KPL-716 were well-tolerated in both adult healthy volunteers and adult subjects with moderate-to-severe atopic dermatitis experiencing moderate-to-severe pruritus, the company said. KPL-716 also demonstrated a reduction in pruritus, it added. "The results support Kiniksa's plans for expanding clinical development into multiple chronic pruritic diseases, including prurigo nodularis," said the company. In total, 50 healthy volunteers and 32 subjects with moderate-to-severe atopic dermatitis experiencing moderate-to-severe pruritus received a single dose of KPL-716 or placebo in the Phase 1a/1b clinical trial, with the top dose of 20 mg/kg IV in healthy volunteers and 7.5 mg/kg IV in subjects with atopic dermatitis. The mean percentage change in weekly-average Worst-Itch Numeric Rating Scale decreased by 40.4% in KPL-716 recipients compared to a 17.6% decrease in placebo recipients at Day 28 in the absence of concomitant TCS. The mean percentage change in Pruritus Visual Analog Scale decreased by 55.4% in KPL-716 recipients compared to a 10.4% decrease in placebo recipients at Day 28 in the absence of concomitant TCS. "The KPL-716 Phase 1a/1b results met a high hurdle for success, as the placebo-controlled, single-dose safety and pharmacokinetics study also demonstrated reduction in pruritus," said John F. Paolini, MD, PhD, Chief Medical Officer of Kiniksa. "We are now considering advancement of KPL-716 into multiple chronic pruritic diseases, including prurigo nodularis. Additionally, the observed reduction in EASI scores after only a single dose of KPL-716 is encouraging. Our ongoing repeat-single-dose trial in atopic dermatitis subjects will provide longer-term exposures and data on these inflammatory disease response markers."