NCX1000 falls short in Ph IIa trial

French biopharmaceutical company NicOx says it has terminated the development of its antihypertensive NCX 1000 (a derivative of ursodeoxycholic acid) after it fell short in a proof-of-concept study. The drug, which was being co-developed in collaboration with Canada's Axcan Pharma as a treatment for portal hypertension, failed to reach predefined efficacy goals in a Phase IIa trial.

NicOx explained that the trial, which was conducted at a single clinical center is Spain, had enrolled 11 patients suffering from portal hypertension, characterized by elevated blood pressure in the liver's portal vein. During the program, patients were randomized to receive escalating doses of the drug (500mg, 1,000mg and 2,000mg), or placebo, for the first two days, followed by three times a day treatment with 2,000mg, or the highest tolerated dose, for 14 days.

The results showed that, while the drug demonstrated good safety and tolerability consistent with previously-reported trials (Marketletters passim), it had not reached primary efficacy targets, defined as the change in portal pressure compared with baseline. NicOx said that it would work with Axcan to fully analyze the findings, which it will disclose at a later date.