First patient enrolled in Certa Therapeutics’ phase II clinical trial for lead candidate FT011

Melbourne, Australia, 18 November 2021: Certa Therapeutics, a biotechnology company focused on improving lives by developing innovative precision treatments for inflammatory and fibrotic diseases, enrols first patient in the Phase II clinical trial evaluating FT011 as an anti-fibrotic drug for the treatment of systemic sclerosis (SSc).

This phase II trial is a randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects and the safety of oral FT011 doses in participants with diffuse SSc.

“It is exciting to get the ball rolling with this phase II clinical trial. Thanks are due to the entire clinical team for their hard work to this point in the start-up of this study so that we have now reached this important milestone with the first patient enrolled. With a total twelve trial sites involved in the study we anticipate being able to complete the study in the projected timeline which forecasts the last patients finishing at the end of 2022,” said Professor Darren Kelly, Chief Executive Officer of Certa Therapeutics.

Certa Therapeutics’ novel compounds block a receptor that is key to pathological fibrosis and provides organ protection in a range of clinical indications. The company is seeking to combine these innovative therapeutics with biomarkers and genetic analysis to identify the most suitable patients for treatment.

SSc is a rare autoimmune disease, causing inflammation and fibrosis (scarring/hardening) of the skin and other organs. There is a clear need for new innovative treatments as currently approved therapies are largely ineffective and can have significant side-effects.

There are currently no treatments available for kidney fibrosis, which presents in the majority of patients with 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. Identifier: NCT04647890