Kadmon Initiates Pivotal Phase 2 Trial of KD025 in Chronic Graft-Versus-Host Disease
NEW YORK, Oct. 25, 2018 (GLOBE NEWSWIRE) -- Kadmon Holdings, Inc. (NYSE: KDMN) today announced that the first patient has been dosed in a pivotal clinical trial of KD025 in chronic graft-versus-host disease (cGVHD). The study will evaluate the efficacy and safety of KD025, Kadmon’s ROCK2 inhibitor, in adults with cGVHD who have received at least two prior lines of systemic therapy. The trial is designed to support a filing for U.S. regulatory approval of KD025.
ROCKstar (KD025-213) is a Phase 2 open-label trial in which patients will be randomized to receive KD025 200 mg QD or KD025 200 mg BID, enrolling 63 patients per arm. Either KD025 dose may be considered by the U.S. Food and Drug Administration (FDA) for the registrational dose. The primary endpoint is the Overall Response Rate (ORR), defined as the percentage of patients who meet the 2014 National Institutes of Health (NIH) Consensus Conference overall response criteria of complete or partial response. The ROCKstar study protocol is based on FDA guidance received in a Type C meeting and was designed in consultation with leading cGVHD experts.
“We are very excited to initiate this registration study, which brings the Company one step closer to our goal to improve outcomes for patients with cGVHD,” said Harlan W. Waksal, M.D., President and CEO at Kadmon. “Achieving this major milestone reflects the hard work of the Kadmon team and underscores the potential of KD025 in cGVHD. We look forward to continuing to work closely with the FDA under our Breakthrough Therapy Designation to complete this important development effort.”
About KD025
KD025 is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response. In previously presented findings from an ongoing Phase 2 clinical trial in cGVHD (KD025-208), KD025 demonstrated a response in approximately two-thirds of patients across Cohort 1 (KD025 200 mg QD) and Cohort 2 (KD025 200 mg BID). KD025 was well tolerated, with no drug-related serious adverse events. The FDA has granted Breakthrough Therapy Designation and Orphan Drug Designation to KD025 for the treatment of cGVHD.
About cGVHD
cGVHD is a common and often fatal complication following hematopoietic stem cell transplantation. In cGVHD, transplanted immune cells (graft) attack the patient’s cells (host), leading to inflammation and fibrosis in multiple tissues, including skin, mouth, eye, joints, liver, lung, esophagus and GI tract.
About Kadmon Holdings, Inc.
Kadmon Holdings, Inc. 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.
Forward Looking Statements
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Contact Information
Ellen Cavaleri, Investor Relations
646.490.2989
