Hope offered to Australians suffering from a rare incurable fibrotic autoimmune disease, as clinical trials on new treatment commence

, September 15, 2021 – Hope offered to Australians suffering from a rare incurable fibrotic autoimmune disease, as clinical trials on new treatment commence
  • Melbourne biotech company, Certa Therapeutics, seeks patients with Diffuse Systemic Scleroderma, a debilitating chronic autoimmune disease, to participate in clinical trials in Melbourne and Adelaide
  • Melbourne man, who received diagnosis on birthday, says Scleroderma is a ‘relentless beast that never lets you go’, that pushed him into an early retirement, but new trials and research offer hope

A new treatment for Diffuse Systemic Scleroderma, a debilitating chronic autoimmune disease that affects 6,000 Australians and has no cure, has begun Phase II trials in Australia.

Diffuse Systemic Scleroderma is an autoimmune condition characterised by thickened skin on the body due to fibrosis, also called scarring. The most life-threatening of Diffuse Systemic Scleroderma’s complications include fibrosis in the lungs, kidney, and heart, with a 10-year survival rate of between 65 to 82 percent.

Melbourne-based former truck dealership General Manager, Russell Davey, received his Scleroderma diagnosis on his birthday five years ago.

“The way this disease affects my body is relentless. If I saw $100 on the street, I couldn’t bend down to pick it up if I wanted to, my joints can’t handle it anymore,” says Davey. “I can’t close a fist to do things like hold a golf club, and the fatigue of an autoimmune condition attacking my body made it impossible to drive to and from my work. It completely changed the way I live my life. It forced me out of my career and ruined my retirement plans with my wife.”

“Scleroderma is a relentless beast that never lets you go. It’s really rare, so often it’s hard to diagnose,” continues Davey. “While it has no current cure or effective treatments, clinical trials and research in this space are all we have to offer us hope to one day break the cycle of this disease.”

Certa Therapeutics is calling for people with Diffuse Systemic Scleroderma to take part in the clinical trial to develop a potentially ground-breaking treatment, with hopes that the drug will also have significant applications for treating fibrotic diseases more broadly.

Phase II trials for Melbourne-based Certa Therapeutics’ orally administered treatment, FT011, are commencing at St Vincent’s Hospital in Melbourne and at the Royal Adelaide Hospital in Adelaide. Up to 30 Australians with Diffuse Systemic Scleroderma who have had the disease for less than 5 years are required for the study. The trial is for 3 months and will require a number of visits to the clinic

Certa’s lead candidate, FT011, blocks a receptor that is a new, previously unknown key driver of fibrosis. Certa uses a new, unique mechanism to ‘switch off’ the receptor which triggers the fibrotic response in the body, effectively stopping further fibrosis from occurring.

Fibrosis is part of the body’s natural healing process for example after a cut or injury. In many conditions, including Scleroderma, excessive fibrosis occurs in the skin and internal organs. In Scleroderma the excessive fibrosis in the skin causes tight hard skin which restricts movement of the hands and limbs. Fibrosis can also occur in other organs in the body leading to stiffness in the lungs or heart, which can lead to heart and lung failure.

Dr Wendy Stevens, Principal Investigator for the St Vincent trial site, says there are currently there are no treatments for diffuse Scleroderma that act as antifibrotics.

“Current treatments for this disease include immunosuppressants, but these do not help many people with the condition who go on to get more extensive skin thickening and tightening, which causes severe functional impairment,” says Dr Stevens. “A therapy that works on the fibrotic pathway is needed in this condition. If shown to be effective in this trial, this treatment may offer new therapy for this devastating condition. The first of these therapies could be on the market within five years.”

Certa’s antifibrotic treatment is being led by Certa CEO and founder Professor Darren Kelly, one of Australia’s leading life science entrepreneurs. A serial entrepreneur, Professor Kelly sold Fibrotech, a company he founded, to Shire for US$500 million in 2014.

Professor Kelly says that FT011 will also be tested against therapeutic targets for more common conditions characterised by inflammatory and fibrotic progression.

“We’ve been working for some time to develop drugs which essentially limit the body’s fibrotic response to injuries or disease-related damage,” says Professor Kelly. “Nearly half of all human disease involves fibrosis so finding a drug-based treatment to stop the progression of fibrosis would be revolutionary. Our initial focus on Diffuse Systemic Scleroderma could be the first step towards a major antifibrotic breakthrough.”

Professor Kelly also says, “We are hosting the Phase II trials in Melbourne and Adelaide so that we can use the sites’ experience in Diffuse Systemic Scleroderma to find participants without people needing to travel significant distances. The clinical trial expertise of these sites is exceptionally well demonstrated, so participants can be assured they will be treated with great care.”

In June 2018, the Medical Research Commercialisation Fund (MRCF), Australia’s largest life science investment fund, and Uniseed, Australia’s longest running venture fund operating at selected Australian universities and CSIRO , invested US$20 million into Certa Therapeutics.

The Phase II trial will be randomised, double blind, and placebo controlled. The trials will extend to European testing sites toward the end of August and start of September. People with Diffuse Systemic Scleroderma can learn more about the trial in the link here.


Trial enquiries

To learn more, or for information on participating in this trial, visit the following websites:



Media enquiries

For more information, photos, or to arrange an interview, contact:

Tori Levy – +64 27 858 1884, tl@manacommunications.com

About Certa Therapeutics (Certa)

Certa Therapeutics’ initial focus is on the development of a treatment for diffuse systemic sclerosis (SSc), a rare autoimmune disease that causes inflammation (thickening) and fibrosis (hardening/scarring) of the skin and other organs. Current approved treatments focus on immunosuppression but are broadly ineffective and have significant side-effects.

FT011, our lead candidate, has demonstrated efficacy in numerous pre-clinical disease models, as well as an excellent safety profile in Phase 1 studies. Our lead Phase 2 study in diffuse systemic sclerosis is currently underway.

Future trial indications focus on renal disease, including Focal Segmental Glomerular Sclerosis (FSGS) and chronic kidney disease (CKD), where fibrosis (scarring) leads to kidney failure and ultimately dialysis or the need for kidney transplantation. There are currently no treatments available for kidney fibrosis, and these diseases place a significant burden on patients and healthcare systems alike. Finding an effective treatment for these patients remains one of the global healthcare industry’s largest unmet needs.