Certa Therapeutics has announced that the US FDA has granted Fast Track Designation for its investigational therapy FT011 for treating systemic sclerosis (scleroderma).
The regulator previously granted FT011 Orphan Drug Designation.
The company said 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 per cent of those treated with FT011 400mg and 20 per cent of patients in the FT011 200mg group, compared to 10 to in the placebo group.
FT011 is a novel, first-in-class oral therapy for treating chronic fibrosis in multiple organs.
It targets an important but previously undrugged membrane GPCR receptor, GPR68, with an extensive body of data demonstrating promising efficacy in multiple models of fibrotic disease.
Transcriptomic research has validated the mechanism of action and demonstrated that treatment with FT011 results in a reversal in the activation of genetic markers associated with fibrosis, providing potential for precision therapy.
Certa CEO Professor Darren Kelly said, “We are thrilled to have received Fast Track Designation which supports further acceleration of the FT011 clinical development program. It is 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.”
Certa said preparations are progressing toward a pivotal clinical trial of FT011 as a treatment for scleroderma.
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