Fezagepras, our lead candidate, has been proven in pre-clinical models to be an anti-inflammatory and anti-fibrotic agent. In December 2020, fezagepras entered a Phase 1 multi-ascending dose clinical trial in the UK to evaluate multiple-ascending doses (MAD) in normal healthy volunteers, at daily dose exposures higher than those evaluated in our previously completed Phase 2 clinical trials.
Fezagepras has been proven in pre-clinical models to be an anti-inflammatory and anti-fibrotic agent. Based on interim pharmacokinetic (“PK”) results from the ongoing fezagepras multiple ascending dose (MAD) study, the Company has decided to stop its plans to move fezagepras into a Phase II clinical study in Idiopathic Pulmonary Fibrosis and a phase Ia/IIb study in Hypertriglyceridemia, as it evaluates the impact of the PK data profile observed in the on-going study.
The Company is continuing to evaluate the interim PK results. Once the MAD study is complete, the Company expects that a full analysis of the complete PK data set from the phase 1 study will help determine the choice of any other potential indication(s) for further development of fezagepras. No dose-limiting adverse events or other potential safety signals have been observed in the MAD study to date.