BioCryst Pharmaceuticals has commenced a Phase I trial evaluating BCX4161 in healthy volunteers for the treatment of hereditary angioedema (HAE).
The study, being conducted at Quotient Clinical in the UK, is designed to assess the safety, pharmacokinetics and pharmacodynamics of BCX4161, a novel selective inhibitor of plasma kallikrein.
BioCryst president and chief executive officer Jon Stonehouse said the daily, oral administration of a safe and effective prophylactic drug would revolutionise treatment for HAE patients.
"BCX4161 has the potential to be the first oral treatment developed specifically for the prevention of HAE attacks," Stonehouse said.
BioCryst BCX4161 previously demonstrated potent and selective inhibition of plasma kallikrein and an encouraging safety profile in nonclinical safety studies and in-vitro and in-vivo studies.
The objectives of Phase I trial are to measure safety, characterise plasma drug levels and estimate the level of kallikrein inhibition achieved subsequent to oral dosing of BCX4161.
The results of the study are anticipated in 2013.
If the objectives of the study are met, a Phase II programme in HAE patients is expected to be undertaken.
