FDA grants Certa Therapeutics’ FT011 orphan drug designation for systemic sclerosis

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The US FDA has granted orphan drug designation for Certa Therapeutics' investigational therapy, FT011, for the treatment of systemic sclerosis (scleroderma).

Scleroderma is a highly debilitating, potentially life-threatening autoimmune condition characterised by inflammation and fibrosis of the skin and other organs (commonly the lungs, kidneys, and heart).

“We are very pleased that the FDA has granted Orphan Drug Designation to FT011, which we believe highlights the urgent need for innovation and new therapeutic options for scleroderma patients”, said Professor Darren Kelly, Certa Therapeutics CEO and founder. “This designation represents an important milestone in the development of FT011, which has the potential to establish first-in-class clinical benefits by precisely targeting the root cause of fibrosis and offer treatment across multiple organs within these patients.”

Certa previously announced positive top-line results from a Phase 2 study, which indicated that treatment with FT011 for 12 weeks resulted in a clinically meaningful improvement in 60 per cent of patients treated with FT011 400mg and 20 per cent of patients in the FT011 200mg group, compared with 10 per cent in the placebo group.