KD025 (also called SLX-2119) is a kinase 2 inhibitor that is being tested for the treatment of idiopathic pulmonary fibrosis (IPF) by the biopharmaceutical company Kadmon. KD025 is a potential first-in-class, oral, selective ROCK2 inhibitor. It potentially could treat autoimmune, fibrotic and neurodegenerative diseases.
People with pulmonary fibrosis have an increase in the kinase 2 inhibitor ROCK2 in their lungs, which may impact biological processes such as macrophage infiltration, endothelial cell activation, and myofibroblast differentiation. These different processes may result in accumulation of more collagen and the formation of scar tissue, leading to malfunctioning of organs and death. Inhibiting ROCK2 may improve scarring and prolong survival in pulmonary fibrosis patients.
Preclinical research demonstrated that kinase inhibition has the potential to stop and reverse scar tissue formation. The selective ROCK2 inhibitor KD025 was successful in treating collagen-induced arthritis in mice and is being tested now in clinical trials for the treatment of psoriasis, chronic graft-versus-host disease, and IPF.
In addition to ROCK2’s potential role in autoimmunity, researchers believe that ROCK2 plays an important role in the development of fibrotic diseases. Preclinical studies showed that KD025 inhibits ROCK2, reducing type 1 collagen secretion and scar tissue formation, and improving organ function in models of fibrosis. Data from these preliminary studies suggest that treatment with KD025 may prevent the secretion of type 1 collagen as well as the formation of myofibroblasts, cells primarily responsible for the secretion of collagen and the progression of fibrotic diseases. Data also showed that ROCK2 inhibition with KD025 significantly reduced established lung fibrosis and inflammation and improved pulmonary function in a dose-dependent manner.
A Phase 2 open-label study sponsored by Kadmon (NCT02688647) is recruiting participants to evaluate the safety, tolerability, and activity of a once-daily dose of 400 mg of KD025, compared to the treatment determined by each patient’s prescribing physician (usually Esbriet and/ or Ofev). The study intends to enroll 36 participants with IPF; 24 will receive KD025 and 12 will receive their regular treatment for a 24-week period.
The study will evaluate changes in lung function and assess the number of participants with adverse events (this is the measure of safety and tolerability).
Kadmon has not yet released any results from this open-label study, but expects to do so in the last quarter of 2017.
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