BioMarin: first patient begins treatment in phase 2 trial of 6R-BH4 in hypertension

By Lisa Kerner

Charlotte, N.C., July 6 - BioMarin Pharmaceutical Inc. said the first patient has started treatment in the company's double-blind, placebo-controlled phase 2 clinical study of the essential enzyme 6R-BH4 (tetrahydrobiopterin) in the treatment of poorly controlled hypertension.

Data from the study is expected in early 2007.

"Our goal is to confirm results seen earlier in pilot clinical studies that demonstrated that oral administration of 6R-BH4 can reduce blood pressure in individuals who remain hypertensive despite treatment with other medications," chief medical officer Emil Kakkis said in a company news release.

The study of 84 patients will be conducted at up to 25 U.S. sites. Patients will receive oral doses of 5 mg/kg of 6R-BH4 or a placebo twice daily for eight weeks.

Primary endpoint variable of the study is the change in systolic blood pressure from baseline to week eight.

BioMarin is a biopharmaceutical company based in Novato, Calif.

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