NicOx: First patient randomized in phase 2 study of NCX 1000 for portal hypertension

By E. Janene Geiss

Philadelphia, June 22 - NicOx SA said Thursday that patient enrollment is ongoing in a phase 2a trial aimed at assessing the efficacy of NCX 1000 in portal hypertension, through the measurement of portal pressure.

The selected clinical center, which had been actively identifying potential patients for a number of months, has now completed all administrative procedures and was able to effectively randomize the first patient, according to a company news release.

The study is a double-blind, dose-escalating study that will enroll patients with portal hypertension who will receive escalating doses of NCX 1000 or a placebo.

NCX 1000 is a patented, nitric oxide-donating derivative of ursodeoxycholic acid, which is being developed for the treatment of portal hypertension and other complications of chronic liver disease under a co-development and license agreement between NicOx and Axcan Charmane Inc.

In the study, patients will be randomized to receive either a placebo or escalating doses of NCX 1000 (500 mg, 1,000 mg and 2,000 mg as the first three doses during the first two days).

This will be followed by 2,000 mg (or the maximum-tolerated dose) three times a day for the following 14 days.

The primary endpoint of the trial will compare the patients' portal pressure in the fasting state on day 16 of treatment with the corresponding baseline values.

A secondary endpoint will make the same comparison following the consumption of a controlled meal and additional endpoints will follow the response rate (defined in terms of portal pressure reduction), the increase in liver blood flow, clinical safety, tolerability and pharmacokinetics.

Portal hypertension is the most common manifestation of chronic liver disease and is responsible for the majority of the morbidity and mortality related to this disorder.

NicOx is a Sophia-Antipolis, France, biopharmaceutical company focused on developing nitric oxide-donating drugs.

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