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.
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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."
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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.
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By GlobalDataIn 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.
