Kadmon Holdings has dosed the first patient under a Phase 2 clinical trial of KD025, which is its rho-associated coiled-coil kinase 2 (ROCK2) inhibitor to treat chronic graft-versus-host disease (cGVHD).

The randomised, open-label, 24-week study evaluates the safety, tolerability and activity of KD025 dosed at 200mg once daily (QD), 200mg twice daily (BID) or 400mg QD in 48 cGVHD patients within the US.

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cGVHD is an often fatal complication after allogeneic stem cell transplantation, in which donor immune cells attack the recipient’s body, thereby leading to fibrosis in multiple organs.

A preclinical research was conducted by Kadmon in collaboration with Bruce Blazar of the University of Minnesota, which demonstrated that ROCK2 inhibition with KD025 down-regulated clinical symptoms in multiple murine models of cGVHD.

"In this Phase 2 study, we hope to further assess the ability of KD025, our lead ROCK2 inhibitor, to ameliorate the cGVHD process."

KD025 treatment also down-regulated the pro-inflammatory signaling pathways involved in cGVHD pathogenesis, as well as simultaneously up-regulated regulatory cell function in murine models, thereby reducing overall cGVHD progression whilst preserving normal immune function.

Kadmon CEO and president Harlan W. Waksal said: “Kadmon’s preclinical research has demonstrated the potential of ROCK2 inhibition to treat a number of autoimmune and fibrotic diseases, including cGVHD, a serious condition with limited treatment options.

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“In this Phase 2 study, we hope to further assess the ability of KD025, our lead ROCK2 inhibitor, to ameliorate the cGVHD process.”

In addition to cGVHD, Kadmon is investigating the potential of KD025 to treat other autoimmune and fibrotic diseases.

The firm is also carrying out an ongoing Phase 2 clinical study of KD025 for the treatment of idiopathic pulmonary fibrosis, with a planned Phase 2 study in moderate-to-severe psoriasis.