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 offers promise in scleroderma
Darren Kelly
Scleroderma is a rare autoimmune connective tissue and rheumatic disease with a generally poor prognosis. A 2019 study found that patients with the condition have a worse quality of life than those with lupus or rheumatoid arthritis.
Currently available treatments focus on managing symptoms.
Conversely, the focus of the FT011 program is to stop fibrosis, “which is a big problem with patients with scleroderma because they get scar tissue in a range of organs — their skin, potentially in their lungs, kidneys and heart,” Kelly said. “It’s quite a debilitating condition.”
In a recent Phase 2 study, FT011 supported significant clinical improvements in more than 60% of scleroderma patients.
Certa is optimistic that the drug could help improve the quality of life for scleroderma patients, who are often diagnosed between the ages of 30 and 50. The condition affects women more often than men.
“If you can do something and improve their quality of life and these patients can go back to work and feel a lot better, then it’s a huge benefit to society,” Kelly said.
Looking for a partner
Certa is currently designing a worldwide Phase 3 trial for FT011 in scleroderma with a goal of launching the study later in 2023. The study will likely run for 12 months and involve a couple hundred patients in the U.S., Europe, Australia and Asia.
“The goal for the company is to partner with a bigger pharma that is more experienced at doing a Phase 3 and marketing a new drug,” Kelly said.
The company is currently in active discussions with “quite a few large pharmas at the moment,” Kelly said. In particular, Certa is looking for a strategic partner that “fits in this category of immunology, scleroderma or rheumatoid arthritis,” he added.
“We’re engaging in those discussions over time and working toward a partnership as we speak. So it’s an ongoing process.”