Health Boards
Kadmon Corporation Announces the Initiation of KD025 Phase 2 Program in Psoriasis
Quote:
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.”
Source: kadmon.com
*Thank you Jim for pointing this out to me, I don't know how I missed it.
Must have a word with our roving reporters.
