Kadmon Announces Publication of Clinical Data Showing KD025 Improved Clinical Scores in Psoriasis Patients

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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