NEW YORK, NY--(Marketwired - April 08, 2014) - Kadmon Corporation, LLC, today announced the initiation of a Phase 2 program for KD025, the Company's orally bioavailable, potent and highly selective inhibitor of ROCK 2, in the treatment of subjects with moderately severe psoriasis vulgaris who have failed first-line therapy.
The Phase 2 program will begin with a Phase 2a open label study designed to evaluate the activity, safety and tolerability of 200 mg of KD025 administered orally once daily (QD) for 4 weeks in up to eight subjects. The Phase 2a study is expected to be followed, in the third quarter of 2014, by a larger, Phase 2 study which will test KD025 at higher doses. In Phase 1 studies, KD025 was generally well tolerated in healthy volunteers at doses ranging up to 1,000 mg daily, with significant activity, as measured by inhibition of Th17 cell cytokine secretion, at doses as low as 120 mg daily.
Psoriasis is an autoimmune disease that affects many parts of the body but is primarily manifested in the skin. It is characterized by red, scaly plaques that range in coverage from localized areas to almost the entire body surface. While the pathogenesis of psoriasis is not fully understood, it has been recognized that the recently discovered T helper 17 (Th17) cells, highly proinflammatory cells that enhance the clearance of extracellular pathogens but are also associated with multiple autoimmune diseases, may play a critical role. Recent in vitro and in vivo studies with KD025 have demonstrated anti-inflammatory activity mediated by the inhibition of IL-17 and IL-21, cytokines secreted by Th17 cells, as well as promotion of the regulatory function of the immune system's Treg cells through upregulation of pSTAT5.
"Antibodies directed against IL-17 have demonstrated therapeutic benefit in treating psoriasis, but must be injected and can be associated with immunologic adverse events," said John Ryan, Ph.D., M.D., Executive Vice President and Chief Medical Officer of Kadmon. "KD025 inhibits a novel target in this disease, where an oral drug that acts against IL-17, and which can restore balance to the immune system without suppressing its function, would be a significant advancement. We look forward to the results of this program, and to elucidating KD025's potential as a treatment for psoriasis."
"Psoriasis is an autoimmune disease that affects millions of individuals and, beyond its social and psychological burdens, is often associated with cardiovascular disease, depressive illness, and psoriatic arthritis," said Samuel D. Waksal, Ph.D., Chairman and CEO of Kadmon. "KD025 has demonstrated the ability to induce immune homeostasis in a variety of disease models, an effect which, if translated to the clinic, holds transformative potential for psoriasis and other autoimmune disorders. We look forward to the results of this program, and to initiating studies in other autoimmune disorders, including lupus nephritis and non-alcoholic steatohepatitis."
Psoriasis is a chronic, immune-mediated skin disease. It ranges in severity from a few scattered red, scaly plaques to affecting almost the entire body surface. The global prevalence of psoriasis varies by age and geographic region, but is estimated to affect between 2 and 4% of the population in Western countries. The causes of psoriasis are not fully understood, but a number of risk factors are recognized, including family history and environmental risk factors, such as smoking, stress, obesity, and alcohol consumption. No cure exists for psoriasis. Treatments, including immune modulating therapies, are used to control symptoms.
About Kadmon Corporation
Kadmon Corporation, LLC, is a global company built on a 21st-century paradigm for the translation of innovative science into treatment. The company currently offers products and services for the treatment and management of liver diseases, and is pioneering novel medicines in areas of serious disease, including oncology, immunology and infectious, neurodegenerative and ophthalmic diseases. Emphasizing emerging concepts in molecular biology and genomics, Kadmon is developing treatments and treatment combinations that target the metabolomics and signaling pathways associated with disease, with the goal of addressing some of today's most pressing areas of unmet medical need. 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.