Precision medicine with new drugs that stop fibrosis


5 Minute read

Certa Therapeutics has developed a new class of drugs for patients with inflammatory and fibrotic diseases. They are based on research from the University of Melbourne and affiliated organisations.

Key points

  • There are no available products to prevent or reverse fibrosis, which is the leading cause of chronic kidney disease, among other disease impacts
  • Certa Therapeutics has developed a class of drugs to slow fibrosis in multiple organs
  • Phase II clinical trials of the leading drug candidate, FT011, demonstrated improvement in more than two thirds of scleroderma patients
  • The Australian start-up Certa Therapeutics was founded by University of Melbourne researchers.

The outcome

Precision medicine company Certa Therapeutics launched in June 2018 to develop drugs for patients with fibrosis. Lead drug FT011 is ready for Phase III clinical trials, while other drugs in Certa Therapeutics’ pipeline are entering Phase II trials.

The treatments are based on a new class of drugs designed and developed for a specific target on cell surfaces: the GPCR receptor. The receptor is usually activated due to disease or injury, and it plays a role in the development of fibrosis. Treatments that inhibit the GPCR target could thus stop fibrosis in patients, slowing disease progression.

Certa Therapeutics combines these drugs with precision medicine – using genetic testing to identify which patients will best respond to a specific treatment.

The potential market is large. The treatments target fibrosis in:

  • Chronic kidney disease, including kidney disease caused by diabetes
  • Scleroderma, a rare but potentially life-threatening autoimmune disorder
  • Focal segmental glomerular sclerosis caused by kidney inflammation
  • Eye diseases, including diabetic retinopathy and age-related macular degeneration.

“Diabetes alone causes 3.7 million deaths worldwide annually, 2.2 million of which are from diabetes-related cardiovascular and kidney disease,” says Professor Darren Kelly, Director of Biomedical Research at St Vincent’s Hospital and the CEO and Managing Director of Certa Therapeutics.

Kidney scarring by fibrosis is responsible for more than 90 per cent of the deaths of people with kidney disease. Certa Therapeutics could help millions of people worldwide.

The company has attracted investment of more than $A100 million in venture capital funding. In 2023 Certa Therapeutics is raising further funds to complete clinical trials for scleroderma and chronic kidney disease.

The need

There are currently no products to prevent or reverse fibrosis, including the fibrosis triggered by diabetes-related high blood glucose.

“Diabetes-related fibrosis is the leading cause of end-stage kidney disease, which is treatable only with dialysis or a kidney transplant. Preventing fibrosis will reduce or remove the need for these expensive treatments,” says Professor Kelly.

Fibrosis is also a key factor in diabetes-related heart disease, chronic lung disease, autoimmune conditions and eye conditions.

Diabetes alone affects more than 400 million adults around the world, and its prevalence is increasing. It is estimated to account for 12 per cent of global health expenditure, or $US612 billion each year.

The research

Compounds that slow fibrosis in the kidneys and heart were discovered by Professor Darren Kelly and his colleagues at the University of Melbourne’s Faculty of Medicine, Dentistry and Health Sciences, the University’s Bio21 Molecular Science & Biotechnology Institute, and St Vincent’s Hospital Melbourne.

”We identified a lead compound, FT011, which delays kidney disease and heart failure in people with diabetes,” Professor Kelly says.

Follow-on drugs OCX063, FT382 and FT1200 were developed to build on the success of FT011 and address other forms of fibrosis. These include diabetic retinopathy (eye damage caused by diabetes), dry eye syndrome and eye inflammation.

The next generation of drugs to expand Certa Therapeutics’ drug platform is under development.

The team has also developed DNA testing protocols to identify patients more likely to have fibrosis and thus to respond to Certa Therapeutics’ drugs.

Technology development history

The researchers patented their discovery in 2006 and launched pharmaceutical start-up Fibrotech Therapeutics in the same year, with Professor Kelly as CEO. In addition to the researchers, the University of Melbourne, Bio21 and St Vincent’s Hospital each took a stake in the company.

In 2008, Fibrotech received $A7 million investment from three venture capital funds: Melbourne-based Brandon Capital Partners, Australia’s Medical Research Commercialisation Fund (MRCF) and university fund Uniseed. This funding supported animal studies and Phase I clinical trials for FT011, which were completed successfully in 2014.

Global biopharmaceutical company Shire acquired the technology when it bought Fibrotech in 2014. The acquisition agreement included an upfront payment of $US75 million and milestone payments of $US482.5 million. Shire developed the technology further, but subsequently decided to divest it, enabling it to be brought back to Australia.

This led to the launch in 2018 of Certa Therapeutics, whose stakeholders include the founding stakeholders of Fibrotech. The new company has received $A22 million from the Australian Government’s Biomedical Translation Fund, managed by MRCF, and $A3 million from Uniseed. Some of this funding was used to acquire the intellectual property originally transferred in the Fibrotech sale, in addition to other related technology. As part of the deal, Shire takes an 18 per cent stake in Certa Therapeutics and will receive royalties on global sales when products reach market.

Professor Kelly is the CEO of Certa Therapeutics. Having completed safety trials of FT011, the company is now focusing on developing FT011 and DNA testing for fibrosis susceptibility for pivotal clinical trials.


Certa Therapeutics

Shire (now part of Takeda Pharmaceutical Company Limited)

Funding support

Australian Government Biomedical Translation Fund

Brandon Capital Partners

Medical Research Commercialisation Fund



Zammit SC et al (2009) Evaluation and optimization of antifibrotic activity of cinnamoyl anthranilates. Bioorganic & Medicinal Chemistry Letters 19(24): 7003–7006. doi: 10.1016/j.bmcl.2009.09.120


WO 2008/003141: Therapeutic Compounds

WO 2009/079692: Halogenated Analogues of Anti-Fibrotic Agents

WO 2011/047432: Fused Ring Analogies of Anti-Fibrotic Agents

WO 2012/068612: Methods for Treating Eye Diseases Associated with Inflammation & Vascular Proliferation

WO 2020/0055814: Anti-Fibrotic Compounds

First published on 11 September 2023.

Share this article
Case studyResearch Innovation and Commercialisation