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23.11.2020 - 17:45

GlobeNewswire: Idorsia announces positive results of the two Japanese registration studies with clazosentan

Idorsia announces positive results of the two Japanese registration studies
with clazosentan Clazosentan demonstrates significant reduction of
vasospasm-related morbidity and all-cause mortality in patients following
aneurysmal subarachnoid hemorrhage (aSAH) Clazosentan demonstrates significant
reduction of all-cause morbidity and mortality in patients following aSAH in a
pre-planned pooled analysis of data from both studies. Idorsia Japan to file
New Drug Application (NDA) with the Japanese Pharmaceuticals and Medical
Devices Agency (PMDA) in the first half of 2021 Global Phase 3 study "REACT"
investigating the efficacy and safety of clazosentan for the prevention of
clinical deterioration due to vasospasm-related delayed cerebral ischemia in
adult patients following aSAH continues to actively recruit

Allschwil, Switzerland - November 23, 2020
Idorsia Ltd (SIX: IDIA) today announced positive top-line results of the
Japanese registration program investigating clazosentan in adult Japanese
patients post-aSAH.

The program consisted of two double-blind, randomized, placebo-controlled
studies assessing the efficacy and safety of clazosentan in reducing
vasospasm-related morbidity and all-cause mortality events in adult Japanese
patients following aSAH. Patients were randomized to receive continuous
infusion of either 10 mg/hr clazosentan or placebo for up to 15 days following
the onset of aSAH. The two studies followed the same study design, with one
enrolling 221 patients whose aneurysm was secured by surgical clipping and the
other enrolling 221 patients whose aneurysm was secured by endovascular
coiling.

Both studies demonstrated that clazosentan reduced the occurrence of cerebral
vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH
with statistical significance (p < 0.01 for both studies). Cerebral
vasospasm-related morbidity and all-cause mortality was blindly adjudicated by
an independent committee and defined by at least one of the following: All
Death / New cerebral infarction due to cerebral vasospasm / Delayed Ischemic
Neurologic Deficit (DIND) due to cerebral vasospasm. Clazosentan showed a
numerical reduction of all-cause morbidity and mortality in both studies. The
effect of clazosentan on this endpoint was significant (p < 0.05) in a
pre-planned pooled analysis. Further analysis is ongoing including additional
pooled analysis of data from both studies.

The studies confirmed the well documented safety profile of clazosentan which
has now been administered to over 2000 patients around the globe. In these
registration studies in Japanese patients post-aSAH there were no unexpected
safety findings. Treatment emergent adverse events occurring >5% in the
clazosentan group with a difference of >2% compared to placebo were vomiting
and signs of hemodilution or fluid retention (i.e. hyponatremia,
hypoalbuminemia, anemia, pleural effusion, brain and pulmonary edema).

Satoshi Tanaka, Dr Med Sci. and President of Idorsia Pharmaceuticals Japan,
commented:


"I want to start by thanking the investigators and their highly skilled staff
for the excellent conduct of the study. I also thank the Idorsia Japan team,
many of whom have worked on clazosentan for many years and never doubted the
benefit that it could bring to the patients, I'm very proud of the whole team.
Most of all I want to thank the patients who have taken part in this study and
their families, they can all be very proud of being part of this very important
advancement for Japanese patients whose lives are so impacted by this
devastating consequence of aSAH. My team will now rapidly analyze the study in
full detail with the objective to file the NDA with the PMDA in the first half
of 2021 and make the full results available through scientific publication."

Teiji Tominaga, M.D., Ph.D., Professor & Chairman, Department of Neurosurgery,
Tohoku University Graduate School of Medicine commented:
"The clinical consequences of the vasospasm that can follow aSAH can be far
reaching, ranging from neurological to other physical problems that can be very
severe in nature. aSAH is a significant problem in Japan with an incidence
around twice as high as in other countries around the world. This makes the
medical need particularly high in Japan and the discovery of a new therapeutic
option that can help Japanese patients to overcome the consequences of this
devastating condition is important. I have worked with the team to develop
clazosentan since the first studies, it is very rewarding to see the years of
research come to fruition with these great results."

Jean-Paul Clozel MD and Chief Executive Officer of Idorsia commented:
"I would like to congratulate the Japanese team, which under the leadership of
Dr. Satoshi Tanaka, has driven the development of clazosentan with such
enthusiasm, determination, and scientific excellence. The results are highly
clinically relevant and bring significant advancement for patients while
confirming a safety profile that should not limit the use of the drug. The data
are very impressive and give us further reason to intensify our efforts to
finish the recruitment into the global REACT study as soon as possible."

Jean-Paul concluded on a personal note:
"Martine and I have worked on the role of endothelin and the potential of
endothelin receptor antagonism in aSAH for more than 25 years, with the first
publication back in 1993. We had a very clear goal; to help patients following
aSAH, who are often young adults and whose lives can be devastated by the
terrible consequences of cerebral vasospasm. Thanks to the creation of Idorsia,
to the confidence of its investors, and determination of the team, we are now
on a good track to bring a major breakthrough therapy to these patients. This
is immensely rewarding for all of us."

About the global registration program "REACT"
In February 2019, Idorsia initiated REACT, a prospective, multicenter,
double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to
investigate the efficacy and safety of clazosentan for the prevention of
clinical deterioration due to vasospasm-related delayed cerebral ischemia in
adult patients following aSAH. The Phase 3 study builds upon the learnings from
the previous clazosentan studies to identify patients at high risk of vasospasm
and delayed cerebral ischemia, the optimal dose, the best measure to
demonstrate efficacy and an optimized patient management guideline to ensure
patient safety.

Approximately 400 patients - treated either with microsurgical clipping or
endovascular coiling - are being enrolled at approximately 95 sites across 15
countries. Patients are randomized to receive continuous infusion of either
clazosentan (15 mg/hr) or placebo prophylactically, on top of local standard of
care, for a period of up to 14 days. REACT is enrolling aSAH patients
identified as being at high risk of developing vasospasm and subsequent delayed
cerebral ischemia because of high-volume hemorrhage, as assessed by CT scan on
hospital admission. Patients experiencing asymptomatic cerebral vasospasm, as
measured by angiography, within 14 days of aSAH may also be included.
Completion of the study is targeted for the second half of 2022.

Notes to the editor

Available data in Japanese patients
A Phase 2 study in Japanese and Korean patients showed that 10 mg/hr of
clazosentan administered by continuous intravenous infusion significantly
reduced vasospasm and vasospasm-related morbidity and mortality events. The
results are published in Cerebrovascular Diseases (Fujimura M, et al.
Cerebrovasc Dis 2017;44:59-67). On that basis, a registration program was
initiated with clazosentan in Japan in May 2016.

About aneurysmal subarachnoid hemorrhage and cerebral vasospasm
Aneurysmal subarachnoid hemorrhage is a rare condition involving sudden
life-threatening bleeding occurring in the subarachnoid space. It is caused by
the rupture of an aneurysm - a weak, bulging spot on the wall of a cerebral
artery. Emergency surgical repair (endovascular coiling or microsurgical
clipping) is required to stop the hemorrhage.

The bleeding and the release of a vasoconstrictor (endothelin) by the
neighboring vascular endothelium can lead to cerebral vasospasm (constriction
of arteries in the brain) usually occurring between four and fourteen days
after aSAH. This diminishes blood flow to the brain and about one third of
patients consequently experience worsening of their neurological condition.
Cerebral vasospasm is one of the leading secondary causes of disability and
death in those that experience aSAH.

The prevalence of aSAH is estimated to be between 6 and 9 per 100,000
worldwide and is a significant problem in Japan with an incidence around twice
as high as in many other countries of the world.

Available clinical data with clazosentan
Previously, clazosentan was investigated for the prevention of angiographic
vasospasm in patients with aSAH in a Phase 2 study, CONSCIOUS-1, which
demonstrated dose-dependent prevention of vasospasm.

This study was followed by two Phase 3 studies, CONSCIOUS-2 and CONSCIOUS-3,
to assess the effect of clazosentan on the incidence of cerebral
vasospasm-related morbidity and all-cause mortality. The dose of clazosentan (5
mg/h) used in CONSCIOUS-2 did not allow a statistically significant treatment
effect to be observed, resulting in the premature termination of CONSCIOUS-3.
However, an exploratory analysis of the data collected in CONSCIOUS-3 showed
that a higher dose of clazosentan, i.e. 15 mg/h, significantly reduced cerebral
vasospasm-related morbidity and all-cause mortality, with a 44% relative risk
reduction (p=0.0074).

The 15 mg/h dose also significantly reduced the incidence of delayed ischemic
neurological deficit with a 54% relative risk reduction (p=0.0038). In
addition, clazosentan reduced the need for rescue therapy for vasospasm.
Clazosentan did not show any effect of clazosentan on long-term clinical
outcome.

A Phase 2 study in Japanese and Korean patients showed that 10 mg/hr of
clazosentan significantly reduced vasospasm and vasospasm-related morbidity and
mortality events.

A pilot study evaluating the early effect of clazosentan on reversing
established cerebral vasospasm in large proximal cerebral artery segments at
three hours post-initiation suggests that clazosentan has the potential to
improve large vessel vasospasm upon early administration. In a post-hoc
analysis of the effect of clazosentan on reversing established cerebral
vasospasm in the entire cerebral vasculature, including smaller distal vessel
segments and the cerebellar arteries, a clearly visible improvement in vessel
diameter at three and 24 hours could be observed.

The above studies have also established an extensive safety profile with over
2,000 patients treated. The side effects of clazosentan are managed based on
clear protocol  guidelines: hypotension can be mitigated using blood pressure
control with vasopressors in the ICU, while lung complications (such as
pulmonary edema) can be managed by aiming to maintain euvolemia by avoiding
excessive fluid administration.

Key literature
Fujimura M, et al. Cerebrovasc Dis 2017; 44:59-67
Macdonald R L, et al. Stroke. 2012; 43(6):1463-9.
Macdonald R L, et al. The Lancet. Neurology, 2011; 10(7):618-625.
Macdonald R L, et al. Stroke 2008; 39:3015-3021.
Vajkoczy P, et al. Journal of Neurosurgery 2005; 103:9-17.
Roux S. et al. J Pharmacol Exp Ther 1997; 283:1110-1118.
Clozel M, Watanabe H, Life Sciences 1993; 52(9):825-834

About Idorsia
Idorsia Ltd is reaching out for more - We have more ideas, we see more
opportunities and we want to help more patients. In order to achieve this, we
will develop Idorsia into one of Europe's leading biopharmaceutical companies,
with a strong scientific core.

Headquartered in Switzerland - a biotech-hub of Europe - Idorsia is
specialized in the discovery and development of small molecules, to transform
the horizon of therapeutic options. Idorsia has a broad portfolio of innovative
drugs in the pipeline, an experienced team, a fully-functional research center,
and a strong balance sheet - the ideal constellation to bringing R&D efforts to
business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June
2017 and has over 800 highly qualified specialists dedicated to realizing our
ambitious targets.

About Idorsia Pharmaceuticals Japan
Idorsia Pharmaceuticals Japan was established, under the leadership of Dr
Satoshi Tanaka, in 2018 to conduct clinical development and prepare the
commercialization of Idorsia's innovative and promising compounds for patients
in Japan.

For further information, please contact
Andrew C. Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 (0) 58 844 10 10
www.idorsia.com

The above information contains certain "forward-looking statements", relating
to the company's business, which can be identified by the use of
forward-looking terminology such as "estimates", "believes", "expects", "may",
"are expected to", "will", "will continue", "should", "would be", "seeks",
"pending" or "anticipates" or similar expressions, or by discussions of
strategy, plans or intentions. Such statements include descriptions of the
company's investment and research and development programs and anticipated
expenditures in connection therewith, descriptions of new products expected to
be introduced by the company and anticipated customer demand for such products
and products in the company's existing portfolio. Such statements reflect the
current views of the company with respect to future events and are subject to
certain risks, uncertainties and assumptions. Many factors could cause the
actual results, performance or achievements of the company to be materially
different from any future results, performances or achievements that may be
expressed or implied by such forward-looking statements. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those described herein
as anticipated, believed, estimated or expected.



Anhang Medienmitteilung PDF

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