NEW YORK, NY -- (Marketwired) -- 10/15/13 -- Kadmon Corporation, LLC, today announced plans for the initiation of three clinical studies of KD025, an orally bioavailable, potent and highly selective inhibitor of ROCK 2 (Rho-associated coiled-coiled kinase 2), in each of three indications: psoriasis, lupus nephritis and non-alcoholic steatohepatitis (NASH). Announcement of the development plans follows the presentation of translational data showing the effects of KD025 on inflammation resolution through two populations of CD4+ T-Cells, the pro-inflammatory cells Th17 and the pro-resolution regulatory T-cells (Treg). The data were presented today by Alexandra Zanin-Zhorov, Ph.D., Kadmon's Senior Director of Immunology, at the Annual Congress of the European Society for Translational Medicine (EUSTM-2013) held October 14 - 16 2013 in Mondorf, Luxembourg.
Th17 cells, and their secretion of the immune regulatory cytokines IL-17 and IL-21, are associated with the pathogenesis of many inflammatory and autoimmune diseases, including psoriasis, lupus nephritis, and NASH, which affect the skin, kidneys and liver, respectively. As demonstrated in preclinical and Phase 1 data, KD025 acts by inhibiting IL-17, IL-21 and IL-22 cytokines, as well as by affecting certain proteins known to regulate the development and survival of Th17 and Treg cells, including inhibition of STAT3 phosphorylation, IRF4 and RORgt levels (upstream from Th17 cells) and up-regulation of STAT5 phosphorylation and Foxp3 (upstream from Treg cells).
These multicenter, Phase 2 studies of KD025 are expected to initiate by or within the first half of 2014.
"Psoriasis, lupus nephritis and NASH affect millions of individuals and can result in severe co-morbidities or early mortality. Yet, there are either no currently approved treatments, or current treatment options both fail to address the underlying disease and carry significant risk," said John Ryan, Ph.D., M.D., Executive Vice President, Chief Medical Officer, of Kadmon. "By selectively inhibiting ROCK 2 signaling, KD025 appears to be instrumental in restoring the balance between pro-inflammatory and regulatory T-cell subsets, doing so in a way that does not suppress the immune system or yield severe side effects. These new studies are each designed to quickly yield proof of concept data in these disease areas."
Dr. Ryan added: "The selective inhibition of ROCK 2 is an area of research with tremendous therapeutic potential, and one where Kadmon remains a world leader. As our KD025 programs advance in the clinic, we are moving a series of other ROCK 2-specific compounds, each with different pharmacodynamic properties, forward."
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 hepatitis C, and is pioneering novel medicines in areas of serious disease, including oncology, infectious diseases, immunology and neurodegenerative 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.
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