Noorik Biopharmaceuticals Ltd., a Swiss biopharmaceutical company developing N-003 (ambrisentan) as a novel therapeutic for the treatment of portal hypertension, announced the completion of its second clinical study.
In this Phase IIa study, subjects with cirrhosis and a history of ascites received N-003 at several, different doses while hospitalised. The key study objectives were to evaluate the safety of N-003, its pharmacokinetic profile and its effect on renal function.
The successful completion of this phase IIa represents a milestone in the development of N-003. Based on these positive findings, a Phase IIb study will be initiated to evaluate the effect of N-003 (ambrisentan) on portal pressure as determined by the Hepatic Venous Pressure Gradient (HVPG) in patients with cirrhosis and a history of refractory ascites. The study is expected to start later in 2018.