Certa Therapeutics announces new clinical trial of investigative candidate

One of our   VC life-science investee companies Certa Theraputics is advancing to Phase 2 trial in treating Diffuse Systemic Scleroderma, a debilitating chronic autoimmune disease.

‍Certa Therapeutics has announced the launch of a Phase 2 trial inAustralia for a potential new treatment for Diffuse Systemic Scleroderma.

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

Certa Therapeutics said it is calling for people with the disease totake part in the clinical trial to develop a potentially ground-breakingtreatment, with hopes that the drug will also have significant applications fortreating fibrotic diseases more broadly.

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

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

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

Dr Wendy Stevens, the principal investigator for the St Vincent trialsite, says there are currently no treatments for diffuse scleroderma that actas antifibrotics.

“Current treatments for this disease include immunosuppressants, butthese do not help many people with the condition who go on to get moreextensive skin thickening and tightening, which causes severe functionalimpairment,” said Dr Stevens.

“A therapy that works on the fibrotic pathway is needed in thiscondition. If shown to be effective in this trial, this treatment may offer newtherapy for this devastating condition. The first of these therapies could beon the market within five years.”

Certa CEO and founder Professor Darren Kelly saidthat FT011 will also be tested against therapeutic targets for more commonconditions characterised by inflammatory and fibrotic progression.

“We’ve been working for some time to develop drugswhich essentially limit the body’s fibrotic response to injuries ordisease-related damage,” said Professor Kelly.

“Nearly half of all human disease involves fibrosisso finding a drug-based treatment to stop the progression of fibrosis would berevolutionary. Our initial focus on Diffuse Systemic Scleroderma could be thefirst step towards a major antifibrotic breakthrough.”

In June 2018, the Medical ResearchCommercialisation Fund (MRCF), Australia’s largest life science investmentfund, and Uniseed, Australia’s longest-running venture fund operating atselected Australian universities and CSIRO, invested US$20 million into CertaTherapeutics.

 

https://biotechdispatch.com.au/news/certa-therapeutics-announces-new-clinical-trials-of-investigativ