Certa Therapeutics announced that it will present the results of its Phase 2 clinical trial of FT011 in patients with scleroderma at the American College of Rheumatology's annual scientific meeting in the US.
The clinical trial data was presented by study investigator Professor Chris Denton MD, describing 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.
The company said the study safety profile demonstrated that FT011 was safe and well tolerated.
Transcriptomic analysis was conducted from skin biopsy samples to investigate changes to gene signatures over the clinical trial. The company said these transcriptomic results indicated that the systemic fibrotic disease gene signature is modulated after 12 weeks, with an increased fibrosis signature score in the placebo group but significantly, a decrease in the same fibrosis signature score following FT011 400mg treatment.
"This suggests that FT011 may have a positive effect for scleroderma patients by reducing the inflammation and fibrosis associated with the disease," said the company.
Professor Denton, a leading rheumatologist and Joint Director of the Centre for Rheumatology, Royal Free Hospital, London and Professor of Experimental Rheumatology at University College London, said, “The Phase 2 trial demonstrates promising efficacy and safety data for FT011 after 12 weeks of treatment and certainly warrants a further study to assess the potential of FT011 to improve clinical outcomes for scleroderma patients. These results are very encouraging for the scleroderma community and a significant step towards helping patients with this debilitating disease.”
The US FDA recently granted Orphan Drug Designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma).
Certa said preparations are progressing toward a pivotal clinical trial of FT011 as a treatment for scleroderma. The company said it intends to start the pivotal study in late-2024.
Certa Therapeutics CEO and founder Professor Darren Kelly said, “We are pleased to have these exceptional clinical trial results presented to the scientific community at ACR Convergence, with FT011 demonstrating clinically important differences in multiple efficacy measures on top of standard of care in a short treatment timeframe. It is imperative that effective, safe, and well-tolerated therapeutics are efficiently developed, and which are truly beneficial for a scleroderma patient's quality of life.”
Professor Kelly added, “Scleroderma is a debilitating and life-threatening condition, and extremely complex in the way that the disease manifests itself in patients. As the biological mechanism by which FT011 works precisely targets the root cause of fibrosis, we believe that FT011 is notably differentiated from previously unsuccessful clinical candidates. With the benefit of input from world-leading experts in the field, we are highly focused on advancing the clinical development program for FT011 towards the pivotal efficacy study.”