Kadmon Corporation Initiates Phase 2 Clinical Trial Evaluating KD025 In Psoriasis

NEW YORK, NY--(Marketwired - January 06, 2015) - 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. For more information, visit www.kadmon.com.

This press release contains forward-looking statements. These forward-looking statements are based on management’s expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. The information contained in this press release is believed to be current as of the date of original issue. Kadmon expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.