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Kadmon’s Psoriasis Drug Improved Clinical Scores in Patients in Phase 2 Study

NEW YORK–(BUSINESS WIRE)–Kadmon Holdings, Inc. (NYSE:KDMN) (“Kadmon” or the “Company”) today announced the publication of clinical data from its completed Phase 2 open-label clinical trial of KD025, its oral Rho-associated coiled-coil kinase 2 (“ROCK2”) inhibitor, in patients with moderate to severe psoriasis. In the study, KD025 treatment improved clinical scores and skin pathology in psoriasis patients via concurrent modulation of the pro- and anti-inflammatory immune cell response. The results were published this week in the Cutting Edge section of the Journal of Immunology.

Preclinical and clinical studies by Kadmon researchers have previously demonstrated the importance of the ROCK2 signaling pathway in autoimmune disease settings. To further explore the therapeutic potential of ROCK2 inhibition, Kadmon conducted a 12-week, open-label, Phase 2 study of KD025 in 38 patients with moderate to severe psoriasis. The results demonstrated that KD025 affected the cellular mechanisms associated with psoriasis progression, as measured in both peripheral blood and the skin, leading to improvements in clinical scores of patients at 12 weeks. Specifically, KD025 significantly reduced peripheral blood levels of IL-17 and IL-23, two pro-inflammatory cytokines, and showed a correlation between changes in IL-17 levels and patients’ clinical scores. In addition, researchers observed a concurrent up-regulation of the immunosuppressive cytokine IL-10 and a significant increase in the percentage of Foxp3+ CD4 T cells in blood, which diminish immuno-inflammatory response. Together, these findings demonstrated the potential of selective ROCK2 inhibition to modulate pro- and anti-inflammatory immune cell responses to treat psoriasis.

“We have demonstrated the molecular mechanism of action by which ROCK2 inhibition with KD025 modulates the immune system to treat psoriasis, correlating with improvements in patients’ clinical scores and symptoms,” said Alexandra Zanin-Zhorov, PhD, Vice President, Head of Immunology at Kadmon and corresponding author of the manuscript. “These results are consistent with our previously published preclinical animal models and cell-based in vitro assays and provide further evidence of the importance of ROCK2 signaling in autoimmune diseases like psoriasis.”

“We have demonstrated the crucial role of the ROCK2 signaling pathway in rebalancing immune response in patients, further validating the therapeutic potential of KD025 in autoimmune disease,” said Harlan W. Waksal, M.D., President and CEO at Kadmon. “We hope to confirm these findings in our ongoing placebo-controlled Phase 2 study of KD025 in psoriasis, which will be carried out for a longer time period in a larger patient population.”

The manuscript, titled “Selective Oral ROCK2 Inhibitor Reduces Clinical Scores in Patients with Psoriasis Vulgaris and Normalizes Skin Pathology via Concurrent Regulation of IL-17 and IL-10,” is available on the Journal of Immunology website here.

About Kadmon Holdings, Inc.

Kadmon Holdings, Inc. is a fully integrated biopharmaceutical company focused on developing innovative products for significant unmet medical needs. We have a diversified product pipeline in autoimmune and fibrotic diseases, oncology and genetic diseases.

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