Certa Therapeutics announces new clinical trial of investigative candidate

Certa Therapeutics

has announced the launch of a Phase 2 trial in Australia for a potential new treatment for Diffuse Systemic Scleroderma.

The debilitating chronic autoimmune disease affects around 6,000 Australians and has no cure. It is characterised by thickened skin on the body due to fibrosis. The most life-threatening of its complications include fibrosis in the lungs, kidney, and heart, with a ten-year survival rate of between 65 and 82 per cent.

Certa Therapeutics said it is calling for people with the disease 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.

The Phase 2 trial of orally administered treatment, FT011, is commencing at St Vincent’s Hospital in Melbourne and at the Royal Adelaide Hospital in Adelaide. Up to 30 patients who have had the disease for less than five years are required for the study. The trial is for three months and will require a number of visits to the clinic

The company said FT011 works by blocking a receptor that is a new and previously unknown driver of fibrosis.

Fibrosis is part of the body’s natural healing process. In many conditions, including scleroderma, excessive fibrosis occurs in the skin and internal organs. It causes tight hard skin that restricts movement of the hands and limbs. It can also occur in other organs in the body leading to stiffness in the lungs or heart. This can lead to heart and lung failure.

Dr Wendy Stevens, the principal investigator for the St Vincent trial site, says there are currently 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,” said 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 CEO and founder Professor Darren Kelly said 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,” said 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.”

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.

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