Scleroderma treatment could leap forward with FT011 drug candidate

The story of the scleroderma drug candidate FT011 is one of “tenacity and persistence,” said Darren Kelly, CEO and managing director of Certa Therapeutics, which is developing the drug.

The drug was discovered around 2006 by Kelly’s laboratory at the University of Melbourne and Spencer Williams of the Bio21 Institute.

“It was really [Williams] being the chemist and me being the biologist working together on a problem and developing FT011,” Kelly said.

The drug was the lead asset of a company known as Fibrotech, where Kelly was CEO.  Shire acquired the company in 2014. At that time, the drug had finished a Phase 1A study and was in a Phase 1B diabetic nephropathy trial.

In 2019, Takeda completed the acquisition of Shire, shelving several programs.

“We worked with Shire to take back FT011 and all the technology that was around that, and then set up Certa Therapeutics in 2018,” said Kelly

FT011 off…
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FT011 yielded significant clinical improvements in more than 60% of scleroderma patients

Certa Therapeutics, a Melbourne-based biotech company, announced the results of its Phase 2 clinical trial for FT011, a novel oral therapy for chronic fibrosis.

The trial showed clinically meaningful improvements in more than 60% of scleroderma patients after 12 weeks of treatment.

In the Phase 2 study, 60% of patients treated with a 400 mg dose of FT011 showed a significant clinical improvement at 12 weeks while 20% of patients in the 200 mg did.

Several dimensions of improvement

Clinical trial investigators noted significant advances in lung function, patient self-assessment, and physician evaluation as measured by American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score, skin thickness, lung function, physician-reported assessment and quality of life evaluations.

The drug candidate was well tolerated in the study.

FT011 targets a G protein-coupled receptor (GPCR), which is inactive in…

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