Cardioxyl Pharmaceuticals has announced the positive results of a clinical trial demonstrating that CXL-1427, a novel potential treatment for acute decompensated heart failure (ADHF), was well tolerated in healthy volunteers. The company has now initiated dosing of hospitalised patients with decompensated heart failure in a phase IIa clinical trial designed to further evaluate the drug’s safety and tolerability as well as its dosing levels.
The phase I clinical trial evaluated the safety and tolerability of 24- and 48-hour continuous intravenous infusions of CXL-1427 in 80 healthy volunteers. The trial’s results showed not only that CXL-1427 was well tolerated with limited adverse events, but also that it is clearly haemodynamically active. Cardioxyl’s ongoing phase IIa study is a randomised, double-blinded, placebo-controlled, invasive haemodynamic study designed to evaluate the safety, tolerability and haemodynamic effects of 6-hour intravenous infusions of CXL-1427 in hospitalised patients with advanced heart failure. It is being conducted at up to 34 clinical sites globally and will enrol approximately 48 hospitalised patients.
“We are very encouraged by the results seen in the first clinical trial for CXL-1427,” says ShiYin Foo, Cardioxyl’s chief medical officer, “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, the chemical name for 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 enhance both systolic and diastolic function. Cardioxyl’s proprietary platform of HNO technology has produced a number of candidate therapeutics for treating heart failure, including CXL-1427.