According to the company, results showed that administration of oral Adentri for 10 days, in addition to standard heart failure therapy, was well tolerated and resulted in clinically significant increases in sodium excretion while preserving renal function.
“Worsening kidney function occurs commonly in these patients and it is typically associated with adverse outcomes,” said Barry H. Greenberg, professor of medicine and director of the advanced heart failure program at University of California, San Diego Medical Center. “Our results demonstrate significant increases in salt excretion without significant adverse events on renal function, suggesting that Adentri may have the potential to improve the standard of treatment that is currently offered.”
The trial was a randomized, double blind, placebo-controlled study that sought to assess the pharmacokinetics and pharmacologic effects of Adentri in heart failure patients.
Fifty patients were maintained on their usual medications, including ACE inhibitors and diuretics, and were dosed with placebo or one of four doses of Adentri, administered once daily for 10 days.
The study showed increases in sodium excretion above baseline and placebo beginning on day 1, continuing over the 10-day dosing period. Notably, these effects were not accompanied by reductions in renal function nor substantial increases in potassium excretion.
Trends toward beneficial effects in clinical measures of heart failure, including body weight, edema, and physician global assessment, were also observed.
The incidence of adverse events was similar to placebo, and higher doses of Adentri were not associated with an increase in adverse events. The pharmacokinetic profile was consistent with once daily dosing.