Corthera has initiated its patient enrollment in a Phase II clinical trial of Relaxin, a peptide hormone being developed for acute heart failure (HF) and other acute-care illnesses.
The trial will investigate the efficacy and safety of Relaxin in approximately 300 patients with acute HF, who will be recruited from more than 50 investigational centers worldwide, according to the San Mateo, Calif.-based Corthera.
The company said that the primary outcome measure is the improvement of clinical signs and symptoms of acute heart failure, with additional secondary outcome measures, including improvement in renal function.
“With the current lack of safe and effective therapies for acute heart failure, we are very pleased to advance the development of Relaxin for the benefit of these patients,” said Stan E. Abel, president and CEO of Corthera.
According to the American Heart Association, heart failure is a costly cardiac and renal syndrome affecting more than 550,000 new patients per year, with projected direct and indirect costs at $33.2 billion in 2007.