Shares in French biotechnology firm NicOx fell 4% on the news that a trial of a hypertensive treatment it is co-developing is to be terminated.
NicOx and Canadian drugmaker Axcan Pharma were jointly studying NCX 1000, a nitric oxide-donating derivative of ursodiol, for the treatment of portal hypertension, a late-stage complication of some chronic, advanced liver diseases. A preliminary analysis of 11 patients in a Phase IIa randomised, double-blind, dose-escalating study, in which patients received either escalating doses of NCX-1000 or a placebo, confirmed the safety profile of the compound but “did not demonstrate the efficacy required to support the continuation of this clinical trial,” the firms said.
NicOx and Axcan have terminated the trial but say they are “actively evaluating opportunities for further collaborative development projects involving the French firm's technology, and Axcan is currently evaluating another molecule to be developed in the field of gastroenterology.
Maarten Beekman, vice president of clinical development at NicOx said that the project was “ambitious”, as this indication “represents a major therapeutic challenge as the processes of the disease are not well understood and there are currently no treatments available. Unfortunately, NCX 1000 did not demonstrate the efficacy required to justify further development."
Strong revenue rise in first quarter
There was better news for NiCox on the financial side as the firm posted first-quarter revenues of 8.7 million euros compared to 700,000 euros, boosted by milestone payments from Merck & Co and Pfizer. Net profit was 1.8 million euros, thanks to the positive impact of an R&D tax credit but this “cannot be considered as an indication of the future results of the company expected for 2007,” NiCox noted.
Indeed, it expects to record a net loss for the remainder of 2007, in line with its projection that R&D expenses will increase significantly until the projected launch of naproxcinod, which is in Phase III trials for osteoarthritis. NiCox ended the quarter with cash and equivalents of 201.2 million euros, boosted by the proceeds of a 130 million euro financing.