The fast-track status was based on findings of the previously announced Phase 2 trial that showed a clinically meaningful improvement in 60% of patients treated with FT011 400mg
Certa’s FT011 gets FDA Fast Track for scleroderma. (Credit: Eszter Miller from Pixabay)
Certa Therapeutics has secured Fast Track Designation from the US Food and Drug Administration (FDA) for its investigational therapy FT011 to treat systemic sclerosis (scleroderma).
FT011 is being developed as a novel, first-in-class oral therapy for scleroderma treatment. Previously, it received Orphan Drug Designation from the FDA.
Certa is a biotechnology firm engaged in the development of precision therapies for patients with inflammatory and fibrotic diseases.
The fast-track status was granted based on findings of the previously announced Phase 2 trial that assessed patients for 12 weeks.
According to the results, the treatment of scleroderma patients with FT011 caused a clinically meaningful improvement in 60% of patients treated with FT011 400mg.
Additionally, improvement was observed in 20% of patients in the FT011 200mg group in comparison to 10% in the placebo group.
Certa Therapeutics CEO and founder Darren Kelly said: “We are thrilled to have received Fast Track Designation which supports further acceleration of the FT011 clinical development programme.
“It also provides validation of FT011’s potential to offer patients with scleroderma the first anti-fibrotic and disease-modifying treatment of this type.
“We know that this debilitating and life-threatening disease can severely impact the lives of patients and to date, existing treatments only focus on the relief and management of symptoms, whereas FT011 precisely targets the root cause of fibrosis and has the potential to offer treatment across multiple organs within these patients.”
The FT011 development programme for scleroderma is eligible for several accelerated regulatory review processes under the Fast Track designation.
These processes include the potential for a rolling review of a New Drug Application (NDA), more frequent FDA interactions, and accelerated approval and priority review of an NDA.
Certa is planning to advance a key clinical trial of FT011 as a scleroderma therapy. The design of the clinical trial and related development plans will be reviewed as soon as feasible with the FDA in 2024.
The European Medicines Agency (EMA) will be consulted for additional scientific assistance in mid-2024, to begin the study in late-2024.