NicOx S.A.
(Eurolist: COX) today provided an update on the phase 2a study for NCX
1000, which is covered by its codevelopment agreement with Axcan Pharma
Inc. (Nasdaq: AXCA; TSX: AXP). A preliminary analysis of 11 patients from
this proof-of-concept study in portal hypertension confirmed the safety
profile of NCX 1000 but did not demonstrate the efficacy required to
support the continuation of this clinical trial. As a consequence, Axcan
and NicOx have agreed not to further pursue the development of NCX 1000 and
to terminate the trial.
The trial was a phase 2a, double-blind, dose-escalating
proof-of-concept study in which 11 patients with portal hypertension were
enrolled in a single clinical center in Spain. Portal hypertension is
abnormally raised blood pressure in the portal vein, which carries blood
from the digestive system to the liver (see NOTE). Patients were randomized
to receive either placebo or escalating doses of NCX 1000 (500mg, 1000mg
and 2000mg as the first three doses during the first two days). This was
followed by 2000mg (or the maximum tolerated dose) three times a day for
the following 14 days.
The primary endpoint of the trial was defined as the comparison between
patients' portal pressure in the fasting state on day 16 of treatment with
the corresponding baseline values. A secondary endpoint was the same
comparison following the consumption of a controlled meal and additional
endpoints were based on the response rate (defined in terms of portal
pressure reduction), the increase in liver blood flow, clinical safety,
tolerability and pharmacokinet ics.
NCX 1000 showed good safety and tolerability, confirming the results
observed in two previous phase 1 studies, and NicOx and Axcan will now
proceed with further data analysis and full results will be disclosed at a
later date.
Maarten Beekman, Vice President of Clinical Development at NicOx,
commented: "This ambitious project, jointly conducted by Axcan and NicOx
aimed to develop an efficacious treatment for portal hypertension, a life
threatening complication of chronic liver disease. 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, although we are pleased that the safety and
tolerability of the product were good."
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. The condition is caused by increased
resistance to blood flow through the liver due to structural and blood flow
changes. Consequently, blood is forced to return to the heart using other
vessels, which are not adapted to high pressure and therefore rupture,
causing life threatening bleeding.
NicOx (Bloomberg: COX; FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development of nitric oxide-
donating drugs to meet unmet medical needs. NicOx is targeting the
therapeutic areas of pain and inflammation and cardio-metabolic disease.
Resources are focused on two lead compounds, naproxcinod (formerly HCT
3012); in phase 3 development for the treatment of the signs and symptoms
of osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.
NicOx has strategic partnerships with some of the world's leading
pharmaceutical companies, including Pfizer Inc. and Merck and Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a
public company listed on the Eurolist of Euronext(TM) Paris (segment: Next
Economy).
The elements included in this communication may contain forward-looking
statements subject to certain risks and uncertainties. Actual results of
the company may differ materially from those indicated in the
forward-looking statements because of different risks factors described in
the company's document de reference.
NicOx S.A.
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