Certa Therapeutics Announces International Non-Proprietary Name for its First-in-class GPR68 Inhibitor Asengeprast (FT011)

Melbourne, Australia 16 September 2024: Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with fibrotic diseases, today announces that its lead candidate FT011 has been granted the International Non-Proprietary Name (INN) of ‘asengeprast’ by the World Health Organisation (WHO). Commonly known as a generic name, an INN is a globally recognised, unique name for a pharmaceutical substance or active ingredient.

Certa has pioneered drug development targeting GPR68, an important but previously undrugged membrane GPCR receptor, showing it to be a master switch of fibrosis.

Asengeprast is a novel, first-in-class oral GPR68 antagonist being developed for the treatment of chronic fibrosis in multiple organs. An extensive body of data demonstrates promising efficacy in multiple in vitro and in vivo models of inflammatory and fibrotic disease. Phase I and IIa clinical studies in patients with systemic sclerosis (SSc) have already demonstrated favourable efficacy, safety and pharmacokinetics.

SSc is a chronic, progressive, and potentially life-threatening autoimmune disease characterised by inflammation and fibrosis (scar tissue formation) in the skin and in various internal organs - commonly lungs, kidneys and heart. Skin fibrosis is the distinguishing feature of SSc and is associated with significantly reduced function and disability in patients. Currently, there are no treatments on the market that effectively stop or reverse scarring in the skin and organs.

Professor Darren Kelly Certa Therapeutics CEO and founder said, “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. 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.”

Certa is planning for a Phase IIb confirmatory SSc clinical trial with asengeprast, bringing the company closer to providing better treatment options for patients with fibrosis. It is also developing biomarkers and gene signatures to identify patients most likely to respond to treatment to ensure the best outcomes for those with fibrosis.

Certa has a portfolio of GPR68 inhibitors designed to target other organs being developed for the treatment of a number of fibrosis driven kidney diseases.