BioMarin Pharmaceutical Inc. (BMRN) has completed the enrollment of patients for the Phase II clinical study of 6R-BH4 for the treatment of poorly controlled hypertension. 6R-BH4, commonly known as BH4 or tetrahydrobiopterin, is a naturally occurring enzyme cofactor that is required for numerous biochemical and physiologic processes, including the synthesis of nitric oxide (NO).
6R-BH4 is the same enzyme cofactor currently being evaluated in BioMarin's Phenoptin(TM) (sapropterin dihydrochloride) for phenylketonuria (PKU) program.
The Phase 2, multicenter, double-blind, placebo-controlled study, which was initiated in July 2006, is designed to evaluate the safety and efficacy of 6R-BH4 on blood pressure in patients with poorly controlled systemic hypertension. The study is being conducted at 26 sites in the United States and has enrolled 116 patients, of whom 55 have type 2 diabetes.
The primary endpoint analysis will compare the mean change in systolic blood pressure between the 6R-BH4 and placebo groups after 8 weeks. A secondary endpoint analysis will compare the mean change in diastolic blood pressure between the two groups.
Source: BioMarin
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