Certa Therapeutics, a biotechnology company focused on developing precision therapies for fibrotic diseases, announced that its lead candidate FT011 has been granted the International Non-Proprietary Name (INN) of 'asengeprast' by the World Health Organisation (WHO). This designation marks a significant step in the development of this novel therapy for systemic sclerosis and other fibrotic conditions.
Targeting GPR68 in Fibrotic Diseases
Certa Therapeutics has pioneered drug development targeting GPR68, a G protein-coupled receptor (GPCR) that acts as a master switch of fibrosis. Asengeprast is designed as a first-in-class oral GPR68 antagonist for the treatment of chronic fibrosis across multiple organs. Preclinical data have demonstrated promising efficacy in various in vitro and in vivo models of inflammatory and fibrotic disease.
Clinical Progress and Systemic Sclerosis
Asengeprast has already undergone Phase I and IIa clinical studies in patients with systemic sclerosis (SSc), demonstrating favorable efficacy, safety, and pharmacokinetics. SSc is a chronic, progressive autoimmune disease characterized by inflammation and fibrosis in the skin and internal organs, with skin fibrosis being a distinguishing feature associated with reduced function and disability. Currently, there are no treatments available that effectively halt or reverse scarring in the skin and organs.
"The granting of an INN for our lead drug candidate asengeprast is another important step in its development of this important therapy and follows the granting of EU and US Orphan Drug status and an FDA Fast Track Designation," said Professor Darren Kelly, CEO and founder of Certa Therapeutics. "We are continuing to drive the clinical development of asengeprast and believe it has the potential to address a critical need for people living with SSC, a debilitating condition with the highest mortality amongst rheumatic diseases."
Future Clinical Development
Certa is planning a Phase IIb confirmatory clinical trial of asengeprast in SSc. The company is also developing biomarkers and gene signatures to identify patients most likely to respond to treatment, aligning with a precision medicine approach. Additionally, Certa has a portfolio of GPR68 inhibitors targeting other organs, being developed for various fibrosis-driven kidney diseases.
About Certa Therapeutics
Certa Therapeutics is dedicated to improving the lives of patients with debilitating diseases through novel targeted therapies. Their research focuses on GPR68, which is normally silent in healthy tissue but becomes activated following injury or disease, mediating signaling pathways associated with inflammation and fibrosis. The company aims to combine its innovative therapeutics with biomarkers and genetic analysis to identify patients most likely to benefit from treatment.
