Certa Therapeutics receives FDA IND approval to open Phase II clinical trial for its lead candidate FT011

Melbourne, Australia, 23 February 2021: Certa Therapeutics, a biotechnology company focused on improving lives by developing innovative precision treatments for inflammatory and fibrotic diseases, has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) approval to commence a 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 has demonstrated efficacy in multiple pre-clinical models of inflammatory and fibrotic diseases. 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 chronic kidney disease (CKD) patients. 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.

The clinical trial is titled: A Phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects and safety of oral FT011 doses in participants with diffuse SSc.

The global study will include trial sites in Australia and Europe. The study is expected to commence recruiting mid-2021 and to complete in late 2022.

“Following demonstrated efficacy in numerous pre-clinical disease models, as well as an excellent safety profile during phase I studies, we are excited to progress into our next clinical trial for our lead anti-fibrotic drug candidate, FT011. This represents a major step forward in the development program for FT011, which has the potential to treat systemic sclerosis,” said Professor Darren Kelly, Chief Executive Officer of Certa Therapeutics.

ClinicalTrials.gov Identifier: NCT04647890