OccuRx commences Phase I clinical trial for lead candidate molecule OCX-063

Melbourne, Australia, 18 December 2019: OccuRx, a biotechnology company focused on improving lives by developing innovative precision treatments for inflammatory and fibrotic diseases, today announced the commencement of their Phase I clinical trial for the new compound OCX-063.

The Phase I study will be a randomized, double blind, placebo-controlled, dose-escalating study of the safety, tolerability, food effect and pharmacokinetics of single and repeat doses of OCX063, administered orally to healthy volunteers.

OccuRx is dedicated to identifying and validating novel targets that treat and prevent fibrosis that lead to disease progression and end organ failure. The company’s most advanced molecule drug candidate, OCX063, is being developed as a first-in-class oral therapy for the treatment for both kidney and ocular diseases associated with diabetic complications. OCX063, is a small molecule drug with the potential to prevent the growth of new and abnormal blood vessels and reduce inflammation.

Diabetes continues to be a major public health problem and has many serious complications that affect multiple organs of the body particularly the eye, kidneys and blood vessels. Over time damage to blood vessels of the eyes and filtering units in the kidneys occurs, leading to chronic inflammation, microvascular changes and irreversible fibrosis. This is associated with significant morbidity and/or mortality including end stage kidney disease and, in the eye, diabetic retinopathy and blindness. With no cure available, intensive research is required to develop novel treatment possibilities for these diabetic complications.

There are currently no treatments available for kidney fibrosis, which presents in the majority of patients with chronic kidney disease (CKD). Given the enormous cost of dialysis and kidney transplants to the healthcare system, finding an effective treatment for these patients remains one of the global healthcare industry’s largest unmet needs. OccuRx is using genetic analysis to identify the most suitable patients for treatment.

“Following promising pre-clinical data, we’re excited to progress into our clinical trial program for our lead anti-fibrotic drug candidate OCX063, which may have the potential to have significant benefits to treat and prevent fibrosis.” said Professor Darren Kelly, Executive Chair of OccuRx.

The clinical trial is set to commence recruitment in Q1 2020 with completion expected in Q3 2020.