Movetis’ M0002 Product Progresses to Phase IIb Trial Following Positive Results in Cirrhotic Ascites
News Jul 04, 2008
Movetis NV, a European specialist pharmaceutical company, has announced that M0002 is progressing to phase IIb following positive results of a phase IIa multiple-dosing trial for the treatment of ascites, the accumulation of fluid in the abdomen in patients with liver cirrhosis resulting from liver conditions such as hepatitis C, hepatitis B or alcoholism.
M0002 is an orally-active selective vasopressin 2 receptor antagonist and a member of a new class of compounds, known as aquaretics, which inhibit water reabsorption from the renal collecting duct. The compound induces free water clearance without loss of sodium.
The randomized, double blind, placebo controlled, dose-titration study explored the safety, tolerability, pharmacokinetic profile and efficacy of M0002 in cirrhotic subjects with ascites and hypo- or normonatraemia. It was conducted in Belgium at multiple centers and enrolled 15 patients who were treated once daily with drug or placebo for 15 days.
“The data are encouraging” states Prof Dr. F. Nevens, Chief of Hepatology at the University Hospital in Leuven and principal investigator of the trial. “M0002 was very well tolerated and proved to have a good safety profile. No unexpected side-effects were seen in these very ill patients. The pharmacokinetic profile was in line with expectations.”
Although a small number of patients were included in the study, a trend towards more stabilized and normalized plasma sodium levels was seen in those treated with M0002.
Remi Van den Broeck, Chief Development Officer of Movetis, said “We are delighted with the promising results from the dose-titration trial. We will begin patient recruitment shortly for a Phase IIb dose-finding study. At Movetis we are committed to improving the lives of patients with ascites and we believe that M0002 may eventually offer hope to many who suffer from the condition.”