Turnhout, Belgium (ots/PRNewswire) - Movetis NV, a European
specialist pharmaceutical company, today 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
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."
About cirrhotic ascites
Cirrhosis is a consequence of chronic liver disease, most
commonly caused by alcoholism and hepatitis B or C. It is
characterized by replacement of liver tissue by fibrous scar tissue
as well as regenerative nodules, leading to progressive loss of liver
function. Ascites, the accumulation of fluid in the peritoneal
cavity, is a major complication of cirrhosis. The development of
ascites is a significant marker in the progression of cirrhosis as it
is associated with high mortality over two years, and signifies the
need to consider liver transplantation as a therapeutic option.
Dr. F. Wong, Associate Professor of Medicine at Toronto
General Hospital, when asked for comment on the disease and on the
therapeutic options, said:
"The development of ascites, or fluid in the abdominal cavity, is
a common complication of liver cirrhosis. Its onset signifies the
progression of liver cirrhosis into the decompensated stage with
worsening of prognosis to 50% survival in 2 years. The treatment of
ascites includes the use of dietary sodium restriction, diuretics
(loop diuretics and or spironolactone) and large volume paracentesis.
The continued use of diuretics is limited by the development of
complications such as electrolyte abnormalities, and many patients
eventually become diuretic resistant, that is, the use of diuretics
is no longer resulting in a reduction of ascites. Such patients are
totally dependent on large volume paracentesis as a means of
controlling the ascites. The use of paracentesis is inconvenient to
the patient and requires significant medical manpower."
Both Prof. Wong and Prof. Nevens agree that there is an urgent
need for newer and effective drugs to better manage cirrhotic
patients with ascites.
M0002 is a selective vasopressin 2 receptor antagonist and is a
member of a new class of compounds - aquaretics - that produce
significant diuresis without the loss of electrolytes. Conventional
diuretic drugs, which are currently used to treat ascites, have the
drawback that they promote the excretion of both salt and water,
leading to possibly symptomatic hyponatremia (abnormally low
concentration of sodium in the blood). In contrast, M0002 primarily
increases free water clearance. This important differentiation could
potentially offer clinical advantages in the treatment of cirrhosis
and other disorders caused by water-retention.
Through a clear focus on gastroenterology (GI), Movetis seeks to
improve the lives of millions of patients - both adults and children
- by discovering, developing and ultimately commercialising
innovative treatments targeting GI conditions with a high unmet
medical need. Movetis NV - founded in Belgium in December 2006 - aims
to become a leading European specialty pharmaceutical organisation
focused on GI diseases. Movetis has a broad GI portfolio with one
product in preregistration, two products in clinical development, one
product ready to move into clinical development and four in
preclinical development, all addressing important areas including
chronic constipation, ascites, paediatric reflux in infants, diabetic
gastroparesis, specific subgroups of patients with severe forms of
irritable bowel syndrom or dyspepsia. In addition, Movetis has rights
to a large library of qualified lead compounds with potential for
development in different GI indications and access to know how for
compounds in secretory diarrhoea. The current portfolio has been
licensed from Janssen Pharmaceutica NV, Belgium and Ortho-McNeil
Pharmaceutical Inc., two Johnson & Johnson (J&J) companies.
The current clinical portfolio includes:
@@start.t1@@ - RESOLOR(R) (prucalopride), a compound for the treatment of
chronic constipation currently under review for Marketing Authorization
- M0002, a selective V2 receptor antagonist compound for the
treatment of ascites that is progressing to a phase IIb trial
- M0003, a gastrokinetic compound for the treatment of
paediatric reflux in infants and symptoms of gastroparesis in adults,
which has in Q1 2008 entered a Phase IIa clinical trial in diabetic
and idiopathic gastroparesis.
- M0004, another gastrokinetic compound for motility
complaints related to non-erosive or refractory gastro-oesophageal
reflux disease (GORD).@@end@@
In 2006, Movetis secured 49 million Euros in a series 'A'
financing from major European and US investors - one of the biggest
series 'A' rounds in Europe. These funds are being used to complete
the development and registration filing of prucalopride, and to
continue preclinical and clinical development of other products.
Investors include Sofinnova Partners, J&J, Life Sciences Partners,
Sofinnova Ventures, KBC Private Equity and KBC Private Equity Fund
Biotech, GIMV, Quest for Growth and BIP Investment Partners. Movetis
is based in Turnhout, Belgium.
ots Originaltext: Movetis NV
Im Internet recherchierbar: http://www.presseportal.ch
Vicki Martin, Axon Communications, dd: +44(0)20-8439-9407, e: