Certa Therapeutics releases ground breaking Phase 2 clinical trial results
Portfolio company Certa has released results of the Phase 2 clinical trial of its novel therapy for Scleroderma (an inflammatory skin thickening condition that can also affect a range of internal organs). These show that 60 per cent of the patients treated with lead candidate FT011, saw a significant improvement. In fact, three people scored the maximum level of improvement possible (a score of 1) in just the 12 week trial period. This is a promising result for those suffering this debilitating disease.
What does this mean?
For those of us that do not work in the orbit of life science and drug trials, the significance of these results may be lost. Getting a drug to market requires regulatory approval, which requires safety and efficacy. For Certa’s Phase 2 trial there were 30 patients involved; 10 receiving a high dose, 10 a low dose, and 10 a placebo. The efficacy results were both statistically and clinically significant. This statistical power is unusual for such a small sample size. There were no adverse events either, bolstering the safety profile.
Certa’s trial of their novel therapy was for Scleroderma of the skin. The process can also affect a range of internal organs, which means there is the possibility that this drug can treat a broader group of patients, such as those with diabetes.