Posted by Michael Wonder on 19 Feb 2024
Certa Therapeutics’ FT011 granted US FDA fast track for the treatment of systemic sclerosis
19 February 2024 - Certa Therapeutics today announces that the US FDA has granted fast track designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma), having previously granted orphan drug designation.
The fast track designation was granted based on results of the previously announced Phase 2 study which indicated that treatment of scleroderma patients with FT011 for 12 weeks resulted in a clinically meaningful improvement in 60% of patients treated with FT011 400 mg and 20% of patients in the FT011 200 mg group compared with 10% in the placebo group.
