Certa Therapeutics receives ethics approvals for the Phase II clinical trial of FT011

Melbourne, Australia, 21 January 2021: Certa Therapeutics, a biotechnology company focused on improving lives by developing innovative precision treatments for inflammatory and fibrotic diseases, announce that they have received ethics approvals, to commence the phase II clinical trial studying FT011 as an anti-fibrotic drug for the treatment of systemic sclerosis (SSc).

Certa Therapeutics is a clinical stage biotechnology company dedicated to improving lives by developing innovative first-in-class precision therapies for fibrotic diseases. The company recognises the importance of creating new innovative treatments serious inflammatory and fibrotic diseases which typically have no cure and limitations in current approved therapies which are largely ineffective and can have significant side-effects.

Following receipt of ethics approval, the phase II trial has now opened clinical sites in Australia and Europe and can commence enrolling patients mid-2021 and to complete in late 2022. 

The phase II study of FT011 will be a randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects and safety of oral FT011 doses in participants with diffuse systemic sclerosis.

“We’re excited to receive ethics approval and to commence recruitment into the phase II clinical trial with FT011, which will hopefully bring us closer to having therapies available to treat fibrosis,” said Professor Darren Kelly, Chief Executive Officer of Certa Therapeutics.

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.

ClinicalTrials.gov Identifier: NCT04647890