Wed-07-01-2015, 10:59 AM
It's good to see many new treatments coming forward to help us live with psoriasis, and here is another that expects to announce preliminary results in first half of 2015 of their phase 2 trial of KD025 for the treatment of psoriasis.
Source: kadmon.com
Quote:
Kadmon Corporation, LLC, today announced that the first patient has been dosed in a Phase 2 clinical trial (Study 206) evaluating the safety, efficacy and tolerability of KD025, the Company’s orally bioavailable, potent and highly selective inhibitor of ROCK2 (Rho-associated coiled-coiled kinase 2), in patients with moderate to severe psoriasis vulgaris who failed first-line therapy. The open-label, dose-finding study will examine KD025 administered at doses of 200 mg twice daily and 400 mg once daily for three months in 24 patients at six sites in the United States.
In a Phase 2a single-arm safety study, KD025 demonstrated encouraging pharmacodynamic activity at a lower dose of 200 mg once daily. Administration of KD025 at this dose was generally well tolerated, with all patients showing the previously demonstrated positive changes in inflammatory markers, including a specific decrease in the secretion of IL-17, a pro-inflammatory cytokine that plays a key 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 percent after only one month of treatment.
“Therapies targeting IL-17 have shown significant efficacy in treating psoriasis,” said Mark G. Lebwohl, M.D., Professor and Chair of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai and primary investigator of Study 206. “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.”
“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 2a trial of psoriasis,” said John Ryan, M.D., Ph.D., Executive Vice President and Chief Medical Officer at Kadmon. “We believe this Phase 2 study will provide further insight into the unique activity of KD025 and its potential in treating these diseases.”
About Kadmon Corporation:
Kadmon Corporation, LLC, is a vertically integrated biopharmaceutical company focused on developing innovative products for significant unmet medical needs. We have a diversified product pipeline in oncology, autoimmune and fibrotic diseases, monogenic diseases and metabolic disease.
Source: kadmon.com