Kadmon Initiates Placebo-Controlled Phase 2 Clinical Trial Evaluating KD025 in Psoriasis

September 21, 2016

Kadmon Initiates Placebo-Controlled Phase 2 Clinical Trial Evaluating KD025 in Psoriasis

NEW YORK--(BUSINESS WIRE)-- Kadmon Holdings, Inc. (NYSE:KDMN) today announced that the first patient has been dosed in a double-blind, placebo-controlled Phase 2 clinical trial of KD025, the Company’s oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), in moderate to severe chronic plaque psoriasis. The dose-finding study examines KD025 administered at four doses: 200 mg once daily (QD), 200 mg twice daily (BID), 400 mg QD and 600 mg QD (administered as 400 mg in the morning and 200 mg in the evening) compared to matching placebo BID for 16 weeks in approximately 150 patients in the United States.

The study builds on results from a recently completed open-label Phase 2 clinical study of KD025 in moderate to severe psoriasis, in which 85% of patients completing the trial achieved Psoriasis Area and Severity Index (PASI) score reductions with minimal side effects. Of note, 71% of patients receiving KD025 200 mg BID achieved at least a 50% decrease in PASI score (PASI 50), and 42% of patients receiving KD025 400 mg QD and achieved PASI 50. In addition, 84% of patients for whom measurements were available showed reduced levels of pro-inflammatory cytokine IL-17, the key driver in psoriasis, with minimal effect on the rest of the immune system, potentially avoiding toxicities and increased susceptibility to infections associated with currently available biologic therapies.

“With its demonstrated safety and targeted anti-inflammatory activity, we believe KD025 potentially offers a new approach to treating psoriasis, while preserving normal immune function,” said Harlan W. Waksal, M.D., President and Chief Executive Officer of Kadmon. “We are optimistic that data from our placebo-controlled trial will provide further evidence of the potential value of KD025 as a psoriasis therapy.”

In addition to psoriasis, Kadmon is conducting Phase 2 clinical trials of KD025 in chronic graft-versus-host disease and in idiopathic pulmonary fibrosis, diseases in which ROCK2 signaling is up-regulated.

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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Kadmon Holdings, Inc.
Investor Relations
Ellen Tremaine, 646-490-2989
Maeve Conneighton, 212-600-1902

Source: Kadmon Holdings, Inc.