Cardioxyl Pharmaceuticals has reported positive results from a Phase I clinical trial showing that CXL-1427, a new potential treatment for acute decompensated heart failure (ADHF).
CXL-1427 is an improved second-generation prodrug that breaks down chemically to produce nitroxyl (HNO) and an inactive byproduct following intravenous administration.
The Phase I trial assessed the safety and tolerability of 24- and 48-hour continuous intravenous infusions of CXL-1427 in 80 healthy volunteers.
Results from the Phase I trial showed not only that CXL-1427 was well-tolerated with limited adverse events, but also is clearly hemodynamically active.
The company has started dosing hospitalised patients with decompensated heart failure in a Phase IIa clinical trial designed to further assess the drug’s safety and tolerability as well as its dosing levels.
The ongoing Phase IIa trial is a randomised, double-blinded, placebo-controlled, invasive hemodynamic study designed to assess the safety, tolerability and hemodynamic effects of six-hour intravenous infusions of CXL-1427 in hospitalised patients with advanced heart failure.
About 48 hospitalised patients will be enrolled in the Phase II trial, which is being carried out at up to 34 clinical sites globally.
Cardioxyl chief medical officer ShiYin Foo said: "We are very encouraged by the results seen in the first clinical trial for CXL-1427 and we are excited to have begun our next stage of clinical testing in advanced heart failure patients.
"Heart failure patients have few effective options, and the pre-clinical and clinical data for CXL-1427 suggest that this could be an important new therapy for patients with ADHF."
Nitroxyl (HNO) has been studied for its potential as a treatment for heart failure.
HNO dilates blood vessels and acts directly on the heart through a unique mechanism to safely improve both systolic and diastolic function.
The company’s proprietary platform of HNO technology has produced a number of candidate therapeutics for treating heart failure, including CXL-1427.