»Genkyotex: recruitment of the 1st patient of the Phase 2 study with setanaxib in idiopathic pulmonary fibrosis MyPharma Editions

Posted on Wednesday, September 16, 2020

Genkyotex, the leading biopharmaceutical company in NOX therapies, has announced the recruitment of the 1st patient in the Phase 2 clinical study with setanaxib, the Company’s lead drug candidate, in Idiopathic Pulmonary Fibrosis (IPF). This study, initiated by researchers, is conducted in accordance with the protocol approved by the Food and Drug Administration (FDA) and the relevant ethics committee.

The study is led by Professor Victor Thannickal of the University of Alabama at Birmingham and includes a consortium of five research centers of excellence in the United States. It is funded by an $ 8.9 million grant awarded to Professor Thannickal’s team by the United States National Institutes of Health (NIH). The study aims to assess the safety and efficacy of setanaxib in 60 patients with IPF receiving standard therapy (pirfenidone or nintedanib) over a 24-week period. The dose of setanaxib used will be that of 800 mg / day (400 mg / 2x per day) which demonstrated better efficacy and an equivalent favorable safety profile compared to a dose of 400 mg / day during the Phase 2 study. in primary biliary cholangitis (PBC). Efficacy endpoints include changes in plasma o, o’-dityrosine, a biomarker based on the mechanism of action of setanaxib, as well as standard clinical parameters including the distance walked in 6 minutes and forced vital capacity (FVC). Plasma levels of collagen fragments that may indicate anti-fibrotic activity, as well as the safety and tolerability of setanaxib will also be assessed.

Dr Philippe Wiesel, Executive Vice President and Medical Director of Genkyotex, said: “We are delighted to initiate this Phase 2 study with setanaxib and would like to congratulate Professor Victor Thannickal and his teams for their efforts which have enabled the recruitment of the first patient in the restrictive context linked to the COVID-19 pandemic. The launch of this Phase 2 trial in IPF highlights the therapeutic potential of setanaxib in multiple fibrotic diseases. IPF is an extremely devastating lung disease with no satisfactory treatment solution that would delay or reverse its progression while being well tolerated by patients. Given the anti-fibrotic effects demonstrated by setanaxib in our Phase 2 study in primary biliary cholangitis as well as in numerous preclinical models, we are eager to investigate its efficacy in this new indication. If the results are conclusive, this would be further clinical evidence showing that inhibition of NOX enzymes could become a new paradigm for the treatment of many fibrotic diseases and that our drug candidate could play a leading role in this area. “

Idiopathic Pulmonary Fibrosis (IPF) is a serious chronic disease causing fibrosis (scarring) of the lungs. This scarring of lung tissue causes dyspnea (difficulty in breathing) which gets worse over time. The 5-year survival in the event of idiopathic pulmonary fibrosis is estimated between 20 to 40% 1, which is a higher mortality rate than that of many cancerous pathologies.

Setanaxib was shown to regress pulmonary fibrosis in a preclinical model where instillation of bleomycin in elderly mice results in persistent fibrosis and senescent myofibroblasts resistant to apoptosis. Setanaxib was able to reverse pulmonary fibrosis by inactivating and clearing myofibroblasts through restored sensitivity to pro-apoptotic signals.

Setanaxib demonstrated its positive effect on hepatic stiffness in the Phase 2 study in primary biliary cholangitis (PBC) and the Company is in advanced discussions with regulatory authorities in the United States and Europe on a registration strategy. common in this indication. Setanaxib is also the subject of a Phase 2 investigator-initiated clinical study in another fibrotic disease, diabetic nephropathy associated with type 1 diabetes.

Source and visual: Genkyotex

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