French biopharmaceutical firm Genkyotex has reported positive data from the Phase I trial of its lead product candidate, setanaxib (GKT831), in healthy participants.

A NOX1 and NOX4 inhibitor, setanaxib had demonstrated evidence of anti-fibrotic activity in a Phase II primary biliary cholangitis (PBC) trial.

Data from the latest trial showed that setanaxib was well tolerated at doses up to 1,600mg/day and exhibited generally dose-proportional exposure.

It also showed a favourable safety and pharmacokinetic profile of a high dose of setanaxib in the trial population.

In addition, no safety signal and dose limiting toxicity were noted across various tested doses levels in the trial on 46 healthy adult male and female participants.

The company noted that the latest data supports the analysis of high doses of up to 1,600mg/day and offers an opportunity to carry out a pivotal clinical trial in PBC patients.

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Doses up to 800mg/day were earlier analysed in a 24-week Phase II trial in PBC patients. Data from this trial showed that this dose of setanaxib demonstrated reductions in markers of cholestasis and significant improvement in fatigue was observed.

In the trial, all doses tested were observed to be safe and well tolerated, with no safety signal compared to placebo noted.

Based on the positive Phase II results, Genkyotex plans conduct a Phase III trial with setanaxib in PBC.

Genkyotex CEO Elias Papatheodorou said: “The results of this new Phase I study confirm the excellent safety profile of setanaxib over a broad dose range.

“Moreover, the dose dependent effect observed in the previous Phase II study, together with the increased exposure achieved in this study, and give us the potential to launch a pivotal trial in PBC.”

In addition, setanaxib is being analysed in an investigator-initiated Phase II clinical trial in Type 1 Diabetes and Kidney Disease (DKD).

In July 2019, Genkyotex secured US regulatory approval to conduct a Phase II clinical trial of GKT831 for the treatment of idiopathic pulmonary fibrosis (IPF).