OCX063 / Certa Therap - LARVOL DELTA

A Phase 1b open label study of the pharmacokinetics and safety of oral OCX063 in adults with chronic kidney disease (ANZCTR) - P1/2 | N=12 | Withdrawn | Sponsor: OccuRx Pty Ltd | Not yet recruiting ➔ Withdrawn

Trial withdrawal • Chronic Kidney Disease • Nephrology • Renal Disease

A Phase 1b open label study of the pharmacokinetics and safety of oral OCX063 in adults with chronic kidney disease (ANZCTR) - P1/2 | N=12 | Not yet recruiting | Sponsor: OccuRx Pty Ltd

New P1/2 trial • Chronic Kidney Disease • Nephrology • Renal Disease

A Phase 1b open label study of the pharmacokinetics and safety of oral OCX063 in adults with chronic kidney disease (ANZCTR) - P1/2 | N=12 | Not yet recruiting | Sponsor: OccuRx Pty Ltd

New P1/2 trial • Chronic Kidney Disease • Nephrology • Renal Disease

Transcriptomic analysis of choroidal neovascularization reveals dysregulation of immune and fibrosis pathways that are attenuated by a novel anti-fibrotic treatment. (PubMed, Sci Rep) - "CNV lesion leakage and fibrosis was found to be reduced using OCX063 and gene expression of genes within the TGF-beta signalling pathway. Our findings show the presence of fibrosis gene expression pathways present in the laser induced CNV mouse model and that anti-fibrotic treatments offer the potential to reduce subretinal fibrosis in AMD."

Journal • Fibrosis • Immunology • Wet Age-related Macular Degeneration • CCL2 • CXCL9 • TGFB1 • THBS2

A phase II open label study to determine the ocular pharmacokinetics of oral OCX063. (ANZCTR) - P1/2; N=12; Not yet recruiting; Sponsor: OccuRx Pty Ltd

Clinical • New P1/2 trial • Retinal Disorders

OCX063, a novel small molecule drug, is protective against inflammatory, fibrotic and angiogenic phenotypes in retinal cultures (ARVO 2020) - "We also observed a corresponding increase in p-p38 and p-JNK at pH 6.8 in ARPE19 cells, which was decreased by 10μM OCX063 (p<0.001), suggesting their involvement in the anti-fibrotic properties of OCX063.Conclusions OCX063 prevents retinal inflammation, vascular pathology and fibrosis in various cultures of retinal cells, highlighting its multifactorial effects and potential for treating proliferative retinal diseases. OCX063 is expected to begin a Phase II clinical trial for DR/AMD in 2020."

Preclinical • MAPK8

Oral delivery of a novel small molecule drug, OCX063, protects against vascular leakage and fibrosis in a rodent model of neovascular age-related macular degeneration. (ARVO 2020) - "Combination treatment with OCX063 and anti-VEGF therapies could therefore improve long-term clinical outcomes in patients with nAMD as well as other retinal diseases, including diabetic retinopathy. Clinical trials for oral OCX063 will begin in 2020."

Preclinical