Enrolment completed for Certa Therapeutics’ phase II clinical trial for lead candidate FT011

Melbourne, Australia, 19 July 2022: Certa Therapeutics, a biotechnology company focused on improving lives by developing innovative precision treatments for inflammatory and fibrotic diseases is pleased to announce the completion of patient enrolment in their phase II clinical trial evaluating FT011 as an anti-fibrotic drug for the treatment of systemic sclerosis (SSc).

Certa Therapeutics’ novel compounds block a receptor that is key to pathological fibrosis and may provide organ protection in a range of clinical indications. The company is seeking to combine these innovative therapeutics with biomarkers and genetic analysis to identify and treat the right patients at the right time.

A total of 30 patients have now enrolled in the global trial being conducted with sites in Australia, and Europe.

The phase II trial was a randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects and the safety of oral FT011 doses in participants with diffuse SSc. Top line data from this trial is expected to be released in early 2023.

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.

FT011 has demonstrated efficacy in numerous pre-clinical disease models, as well as an excellent safety profile during phase I studies.

“The team at Certa Therapeutics is pleased to reach this major milestone with enrolment of the final patient in our phase II FT011 clinical trial. We’re excited to continue and progress with the development of FT011, which offers hope to patients with SSc. At this point we would like to extend our sincere thanks to the patients who have participated in this clinical trial, as well as the entire team who have worked diligently to conduct this multinational study within the original timeline forecast. Given the fabulous progress, we anticipate announcing top-line results early in 2023.” said Professor Darren Kelly, Chief Executive Officer of Certa Therapeutics.

ClinicalTrials.gov Identifier: NCT04647890