NicOx continues enrollment in Ph II hypertension study

French biopharmaceutical company NicOx SA says it is continuing to enroll patients in a Phase IIa assessment of NCX 1000 (a derivative of ursodeoxycholic acid), its developmental treatment for portal hypertension. The company added that its clinical center, which has been actively identifying potential enrollees for several months, has completed the required administrative procedures and is initiating patient randomization.

During the trial, which is designed to assess the most effective dose of the drug, subjects will be provided with either 500mg, 1,000mg or 2,000mg of the compound (or placebo) for three days followed by treatment with the maximum dose three times a day for a further two weeks. The primary endpoint will be reduction in portal pressure in the fasting state at day 16, in comparison with baseline. The firm added that it would also assess this criteria at day 16 in patients who have consumed a controlled meal.