The trial is designed to evaluate the safety, efficacy and tolerability of KD025, the company’s orally bioavailable, potent and highly selective inhibitor of Rho-associated coiled-coiled kinase 2 (ROCK2), in these patients.
During the open-label, dose-finding trial, KD025 will be examined when administered at doses of 200mg twice daily and 400mg once daily for three months in 24 patients at six sites in the US.
In a Phase IIa single-arm safety trial, KD025 showed encouraging pharmacodynamic activity at a lower dose of 200mg once daily.
Icahn School of Medicine at Mount Sinai professor and chair of the Department of Dermatology Mark Lebwohl said: "Therapies targeting IL-17 have shown significant efficacy in treating psoriasis.
"KD025 represents a novel oral approach to treating psoriasis by blocking IL-17 secretion, while concurrently increasing the suppressive function of regulatory T-cells (Treg), helping to resolve inflammation with a minimal effect on the rest of the immune response."
The company said that administration of KD025 200mg once daily was generally well tolerated, with all patients showing the previously showed positive changes in inflammatory markers, including a specific decrease in the secretion of IL-17, a pro-inflammatory cytokine that plays a major role in psoriasis.
In addition, three of the eight patients showed a decrease in Psoriasis Area and Severity Index (PASI) scores of up to 66% after only one month of treatment.
Kadmon executive vice-president Dr John Ryan said: "Selective ROCK2 inhibition by KD025 has demonstrated activity in preclinical models of autoimmune and fibrotic diseases.
"We have also demonstrated clinical activity of KD025 in a Phase IIa trial of psoriasis.
"We believe this Phase II study will provide further insight into the unique activity of KD025 and its potential in treating these diseases."
Image: Plaque psoriasis on an arm. Photo: courtesy of en:User:Marnanel.