Genkyotex Reports Progress of Setanaxib Phase 2 Investigator Initiated Trials

• Phase 2 DKD trial funded by JDRF to expand in Europe and New Zealand
   
• 13 patients have completed full 48-week treatment in DKD trial; no safety signals identified
   
• Phase 2 IPF trial funded by NIH; poised to initiate patient enrollment following recently received FDA and IRB approvals

ARCHAMPS, France, Dec. 03, 2019 (GLOBE NEWSWIRE) -- Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX) a biopharmaceutical company and the leader in NOX therapies, announces today further progress in two investigator-initiated Phase II trials of setanaxib in diabetic kidney disease (DKD) and idiopathic pulmonary fibrosis (IPF).

The principal investigators leading the DKD trial decided, with agreement from Genkyotex, to expand the investigational network by adding centers in Germany, Denmark and New Zealand. New Zealand will be the first country to add centers and will be followed by Germany and Denmark. In addition, following the positive efficacy and safety results of the Company’s Phase 2 trial of setanaxib in primary biliary cholangitis (PBC), the DKD trial protocol was amended to increase the dose to 400 mg BID. Importantly, 13 patients have already completed the full 48-week treatment and no safety signals have been identified. In DKD, the progressive loss of renal function is driven by fibrotic remodeling in renal glomeruli (glomerulosclerosis) and interstitium (interstitial fibrosis), and setanaxib has shown marked anti-inflammatory and anti-fibrotic effects in multiple preclinical models.

Separately, the U.S. Food and Drug Administration (FDA) and the relevant Institutional Review Boards (IRB) have now approved the protocol of the Phase II IPF trial, paving the way for patient enrollment, which is expected in the coming weeks. This trial is fully funded by an $8.9 million grant awarded by the U.S. National Institutes of Health (NIH). The study is being led by Professor Victor Thannickal at the University of Alabama at Birmingham and includes a consortium of five centers of excellence. The study will evaluate the safety and efficacy of setanaxib in 60 IPF patients receiving standard of care therapy (pirfenidone or nintedanib).