The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Certa Therapeutics’ investigational therapy FT011 for the treatment of systemic sclerosis.
FT011 is a novel, first-in-class oral therapy for the treatment of chronic fibrosis in multiple organs. It targets a GPCR receptor, GPCR68, 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 reversal in the activation of genetic markers associated with fibrosis, providing potential for a precision therapy.
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 400mg and 20% of patients in the FT011 200mg group compared with 10% in the placebo group. The drug had previously been granted Orphan Drug Designation by the FDA.
Under the Fast Track Designation, the FT011 development program for scleroderma is eligible for various expedited regulatory review processes, including generally more frequent FDA interactions, potential eligibility for rolling review of a New Drug Application (NDA) and accelerated approval and priority review of an NDA.
Certa is working toward a pivotal clinical trial of FT011 as a treatment for scleroderma. Supported by global clinical experts, the clinical trial design and associated development plans will be discussed with the FDA as soon as possible in 2024, with complementary scientific advice sought from the EMA mid-2024, with the aim of starting the pivotal study in late-2024.
“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,” says Professor Darren Kelly, Certa Therapeutics CEO and Founder, in a news release.