NEW YORK, NY / ACCESSWIRE / July 9, 2019 / Kadmon Holdings, Inc. (NYSE: KDMN) today announced that the first patient has been dosed in a Phase 2 clinical trial of KD025, the Company's ROCK2 inhibitor, in patients with diffuse cutaneous systemic sclerosis (SSc). SSc is a chronic immune disorder characterized by fibrosis of the skin and internal organs, affecting approximately 75,000 to 100,000 people in the United States.
The double-blind, placebo-controlled Phase 2 study (KD025-209) will randomize 60 adults with SSc to receive KD025 200 mg QD, KD025 200 mg BID or placebo (20 per arm) for 24 weeks, followed by an open-label extension period to allow treatment for up to 52 weeks. The primary endpoint is the Combined Response Index for Systemic Sclerosis (CRISS) score at 24 weeks. The CRISS score is a measure of clinical and patient-reported outcomes that conveys the likelihood that a patient with diffuse cutaneous SSc has improved.
In addition to systemic sclerosis, Kadmon is developing KD025 for the treatment of chronic graft-versus-host disease (cGVHD), for which a registration trial is ongoing. Kadmon expects to complete enrollment and provide guidance on its initial data analysis of the cGVHD registration trial in the second half of 2019.
"We are pleased to extend our development of KD025 to systemic sclerosis, a chronic, multi-system disease that is closely related to cGVHD," said Harlan W. Waksal, M.D., President and CEO at Kadmon. "Based on encouraging results observed with KD025 in cGVHD patients, including responses in hard-to-treat fibrotic manifestations in lung and skin, we believe KD025 is well suited to treat patients with systemic sclerosis. This new study of KD025 further supports our goal to develop therapies for patients with serious unmet medical needs, particularly in inflammatory and fibrotic diseases."
KD025 is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response. Enrollment is ongoing in KD025-213, a registration trial of KD025 in adults and adolescents with cGVHD who have received at least two prior lines of systemic therapy. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation and Orphan Drug Designation to KD025 for the treatment of cGVHD. Enrollment is also ongoing in a Phase 2 clinical trial of KD025 in adults with diffuse cutaneous SSc (KD025-209).
Kadmon is a fully integrated biopharmaceutical company developing innovative product candidates for significant unmet medical needs. Our product pipeline is focused on inflammatory and fibrotic diseases as well as immuno-oncology.
Forward Looking Statements
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Ellen Cavaleri, Investor Relations
SOURCE: Kadmon Holdings, Inc.
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