Actelion provides update on Phase III GRIPHON study with selexipag in pulmonary arterial hypertension - Study continues
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Actelion Pharmaceuticals Ltd /
Actelion provides update on Phase III GRIPHON study with selexipag in pulmonary
arterial hypertension - Study continues
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ALLSCHWIL, SWITZERLAND - 08 May 2013 - Actelion Ltd (SIX: ATLN) announced today
that the Independent Data Monitoring Committee (DMC) has informed the company of
its unanimous recommendation to continue the pivotal Phase III study, GRIPHON.
In addition the DMC had no recommendations for any modification in study design
or procedures.
The placebo-controlled, randomized GRIPHON study is designed to evaluate the
efficacy and safety of selexipag in 1'150 patients with pulmonary arterial
hypertension (PAH) in an event-driven morbidity/mortality study.
Selexipag is an orally available selective IP receptor agonist that - in a Phase
II study - showed a significant reduction in pulmonary vascular resistance
(PVR). Pulmonary arterial hypertension (PAH) is a syndrome characterized by a
progressive increase in pulmonary vascular resistance.
As described in the study protocol, the GRIPHON DMC was scheduled to perform an
interim analysis at around two thirds of the overall foreseen
morbidity/mortality events were observed, in addition to the evaluation of
patient safety in the study. The goal of the interim analysis was to assess
whether study continuation was warranted based on the primary objective of
demonstrating morbidity/mortality benefits.
With the interim analysis now successfully concluded and the DMC recommending
study continuation as planned, final study results of this event-driven study
are now expected by mid-2014.
###
Notes to Editor:
ABOUT GRIPHON
GRIPHON, (Prostacyclin (PGI2) Receptor agonist in pulmonary arterial
hypertension) is a multicenter, double-blind, placebo-controlled trial
evaluating the long-term efficacy and safety of oral selexipag in patients with
pulmonary arterial hypertension.
GRIPHON is close to full enrollment with 1'143 patients randomized, of the
targeted 1'150, and represents the largest randomized, controlled study in PAH
patients. This pivotal study is designed to demonstrate a reduction in risk of
morbidity/mortality events of selexipag treatment compared to placebo and
evaluate the safety of the selexipag in PAH patients. Results are expected to be
available mid-2014.
ABOUT SELEXIPAG
Selexipag, originally discovered and synthesized by Nippon Shinyaku, is a first-
in-class, potent, orally available, selective IP receptor agonist. Selexipag has
major potential as a novel treatment of pulmonary arterial hypertension.[1,2,4]
Results of a Phase II, 43-patient, placebo-controlled, double-blind study, where
patients were randomized in a 3:1 ratio receiving selexipag or placebo on top of
PDE5 and/or ERA, showed a statistically significant reduction in pulmonary
vascular resistance (PVR; primary parameter for the study). The treatment effect
was shown to be 30.3% after 17 weeks of treatment (p=0.0045). Results also
showed an encouraging numerical improvement in 6-minute walk distance (6MWD),
which was a secondary endpoint of this trial. Selexipag was well tolerated and
the safety profile was in-line with the expected pharmacologic effect. [3]
ABOUT PULMONARY ARTERIAL HYPERTENSION (PAH)
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder
characterized by abnormally high blood pressure in the arteries between the
heart and lungs of an affected individual. The symptoms of PAH are non-specific
and can range from mild breathlessness and fatigue during normal daily activity
to symptoms of right heart failure and severe restrictions on exercise capacity
and ultimately reduced life expectancy.
PAH is one group within the classification of pulmonary hypertension (PH). This
group includes idiopathic PAH, heritable PAH and PAH caused by factors which
include connective tissue disease, HIV infection and congenital heart disease.
The last decade has seen significant advances in the understanding of the
pathophysiology of PAH, which has been paralleled with developments of treatment
guidelines and new therapies. Drugs targeting the 3 pathways that have been
established in the pathogenesis of PAH are endothelin receptor antagonists
(ERAs), prostacyclins and phosphodiesterase-5 inhibitors. PAH treatments have
transformed the prognosis for PAH patients from symptomatic improvements in
exercise tolerance 10 years ago to delayed disease progression today. Improved
disease awareness and evidence-based guidelines developed from randomized
controlled clinical trial data have highlighted the need for early intervention,
goal-oriented treatment and combination therapy.
Despite these advances in PAH, survival rates are unacceptably low and PAH
remains incurable.
ABOUT PROSTACYCLIN
Prostacyclin and prostaglandins are types of prostanoids. Endothelial cells
produce several vasoactive chemical factors, among them prostacyclin (PGI(2)),
which induce vasodilation of blood vessels and inhibit smooth muscle cell
proliferation and platelet aggregation. The peptide endothelin is also produced
by the endothelium, and is a potent constrictor of blood vessels and promotes
cell proliferation. In a normal healthy state, prostacyclin helps counter-
balance the actions of endothelin. In certain disease conditions, however,
production of prostacyclin by the endothelium is impaired, allowing the
deleterious effects of excessive levels of endothelin to predominate.
ABOUT PROSTACYCLIN RECEPTOR AGONISM
The IP receptor (PGI(2) (prostacyclin) receptor) is one of 5 types of prostanoid
receptor available to prostanoid replacement therapies. Prostacyclin activates
the IP receptor inducing vasodilation and inhibiting proliferation of vascular
smooth muscle cells. With selective IP receptor agonism, the risk of side
effects mediated by activation of other prostanoid receptors may be minimized.
Actelion is developing a first-in-class, orally available, selective IP receptor
agonist that mimics the actions of endogenous prostacyclin for the treatment of
PAH.
ABOUT THE ACTELION / NIPPON SHINYAKU ALLIANCE
Actelion and Nippon Shinyaku entered into an exclusive worldwide alliance in
April 2008 to collaborate on selexipag, a first-in-class orally-available,
selective IP receptor agonist for patients suffering from pulmonary arterial
hypertension (PAH). This compound was originally discovered and synthesized by
Nippon Shinyaku. Phase II evaluation has been completed, and a Phase III program
in PAH patients has been initiated. Actelion is responsible for global
development and commercialization of selexipag outside Japan, while the two
companies will co-develop and co-commercialize in Japan. Nippon Shinyaku will
receive milestone payments based on development stage and sales milestones as
well as royalties on any sales of selexipag.
References
1. Kuwano et al. NS-304, an orally available and long-acting prostacyclin
receptor agonist prodrug. J Pharmacol Exp Ther 2007;322:1181-1188.
2. Kuwano et al. A long-acting and highly selective prostacyclin receptor
agonist prodrug, NS-304, ameliorates rat pulmonary hypertension with unique
relaxant responses of its active form MRE-269 on rat pulmonary artery. J
Pharmacol Exp Ther 2008;326:691-699.
3. Simonneau G, Lang I, Torbicki A, Hoeper MM, Delcroix M, Karlocai K, Galie N.
Selexipag, an oral, selective IP receptor agonist for the treatment of
pulmonary arterial hypertension Eur Respir J 2012; 40: 874-880
4. Mubarak KK. A review of prostaglandin analogs in the management of patients
with pulmonary arterial hypertension. Respir Med 2010;104:9-21.
NIPPON SHINYAKU
For further information on Nippon Shinyaku please visit:
http://www.nippon-shinyaku.co.jp/english/index.html
ACTELION LTD
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in
Allschwil/Basel, Switzerland. Actelion's first drug Tracleer(®), an orally
available dual endothelin receptor antagonist, has been approved as a therapy
for pulmonary arterial hypertension. Actelion markets Tracleer(®) through its
own subsidiaries in key markets worldwide, including the United States (based in
South San Francisco), the European Union, Japan, Canada, Australia and
Switzerland. Actelion, founded in late 1997, is a leading player in innovative
science related to the endothelium - the single layer of cells separating every
blood vessel from the blood stream. Actelion's over 2,300 employees focus on the
discovery, development and marketing of innovative drugs for significant unmet
medical needs. Actelion shares are traded on the SIX Swiss Exchange (ticker
symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index
SMI(®)).
For further information please contact:
Roland Haefeli
Vice President, Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
http://www.actelion.com
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[HUG#1700039]
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Datum: 08.05.2013 - 07:00 Uhr
Sprache: Deutsch
News-ID 257368
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contact information:
Town:
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