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GlobeNewswire: Clinical data on Idorsia's pipeline compounds will be presented at the European Society of Cardiology Congress 2019

23.08.2019, 17:35 Uhr

Clinical data on Idorsia's pipeline compounds will be presented at the
European Society of Cardiology Congress 2019

Allschwil, Switzerland - August 23, 2019


Idorsia Ltd (SIX: IDIA) today announced that data from Phase 2 studies with
aprocitentan, a new dual endothelin receptor antagonist, and selatogrel, a
highly-selective P2Y 12 receptor antagonist, will be shared during the European
Society of Cardiology (ESC) Congress 2019 in Paris, France.

Idorsia's aprocitentan
An oral presentation entitled " Efficacy and safety of various doses of the
new dual endothelin receptor antagonist aprocitentan in the treatment of
hypertension ", will be part of the " Drug treatment in hypertension - New
insights " session with a focused discussion with the lead author, Dr Parisa
Danaietash from Idorsia, at 09:54 on August 31, 2019. The abstract can be found
online .

Idorsia's selatogrel
An oral presentation entitled " Selatogrel, a novel P2Y 12 inhibitor for
emergency use, achieves rapid, consistent and sustained platelet inhibition
following single-dose subcutaneous administration in stable CAD patients ",
will be part of the " New developments in anti-thrombotic drug therapy "
session with a focused discussion with the lead author, Professor Robert
Storey, BM, Professor of Cardiology, University of Sheffield, UK, at 17:15 on
September 1, 2019. The abstract can be found online .

A second oral presentation entitled " Inhibition of platelet aggregation after
subcutaneous administration of a single-dose of selatogrel, a novel P2Y 12
antagonist, in acute myocardial infarction: A randomised open-label phase 2
study ", will be part of the " Emerging treatments in acute coronary syndromes
" session with a focused discussion with the lead author, Professor Peter
Sinnaeve, MD, Department of Cardiology, University Hospitals Leuven, Faculty of
Medicine, University of Leuven, Belgium, at 11:34 on September 3, 2019. The
abstract can be found online .

In addition, Idorsia representatives will be present at Stand B320 from 10:00
- 17:00 on Saturday, August 31, until Tuesday, September 3.

_______________

Notes to the editor

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About aprocitentan
Aprocitentan is an orally active dual endothelin receptor antagonist, which is
being investigated for patients whose hypertension is uncontrolled despite the
use of three or more antihypertensive drugs.

In June 2018, Idorsia initiated PRECISION, a multi-center, double-blinded,
placebo-controlled, randomized, parallel-group, Phase 3 study to demonstrate
the antihypertensive effect of aprocitentan when added to standard of care in
patients with resistant hypertension. Idorsia, in consultation with regulatory
agencies, has designed a single study which will efficiently address both the
short-term efficacy of aprocitentan and the durability of its effects in
long-term treatment.

Patients with a history of resistant hypertension will undergo a thorough
screening and run-in period. This will confirm the diagnosis of resistant
hypertension by excluding pseudo or apparent resistant hypertension. During the
screening period, the patient's background antihypertensive therapies will be
transitioned to a standardized fixed combination of a calcium channel blocker
(amlodipine), an angiotensin receptor blocker (valsartan), and a diuretic
(hydrochlorothiazide).

Patients with true resistant hypertension will then be randomized to receive
aprocitentan 12.5 mg, 25 mg, or placebo once-daily. The study consists of 3
sequential treatment periods. The first is a double-bind treatment period
designed to demonstrate the effect of aprocitentan on blood pressure at Week 4,
compared to placebo. Patients then enter a treatment period where they are
treated with aprocitentan 25 mg for 32 weeks. This is followed by a
double-blind, randomized withdrawal treatment period where patients will remain
either on aprocitentan 25 mg or switch to placebo for 12 weeks. The latter
treatment period is designed to demonstrate the durability of the blood
pressure lowering effect of aprocitentan. Patients will then enter a 30-day
safety follow-up period.

From the initial screened patient population, at least 600 patients will be
randomized and at least 300 patients are expected to complete the study. The
study will be conducted in approximately 100 sites in around 20 countries.

In December 2017, Janssen Biotech, Inc. entered into a collaboration agreement
with Idorsia to jointly develop and commercialize aprocitentan and any of its
derivative compounds or products. Both parties have joint development rights
over aprocitentan. Idorsia will oversee the Phase 3 development and regulatory
submission. The costs will be shared equally between both partners. Janssen
will oversee the Phase 3 development and submission for any additional
indications.

Aprocitentan at ESC-19
Oral presentation:
Efficacy and safety of various doses of the new dual endothelin receptor
antagonist aprocitentan in the treatment of hypertension.
Session: Drug treatment in hypertension - new insights, 34.
P Danaietash, P Verweij, B Flamion, J Menard, M Bellet; Idorsia
Pharmaceuticals Ltd, Allschwil, Switzerland, Clinical Investigation Centre,
Inserm /Assistance Publique, Hôpitaux de Paris, Hôpital Européen and Université
Paris-Descartes, Paris, France.
Saturday, August 31, 2019, 09:54 - 10:12

About selatogrel
Selatogrel is a highly-selective P2Y 12 receptor antagonist developed for
acute coronary syndrome.

Two Phase 2 studies in patients with stable coronary artery disease and acute
myocardial infarction, respectively, have met their pharmacodynamic objectives
of significantly inhibiting platelet aggregation. Subcutaneous administration
of selatogrel 8 mg and 16 mg has demonstrated a rapid onset of action, within
15 minutes, with the height of its effect extending over 4-8 hours, depending
on the dose. The predefined extent of platelet aggregation inhibition was seen
in at least 89% of the patients in both chronic and acute situations across
doses. Selatogrel was safe and well tolerated in both studies and there were no
treatment-emergent serious bleeds. Idorsia is now preparing for the end of
Phase 2 meetings with health authorities where it will discuss a Phase 3 study.


Selatogrel at ESC-19
Oral presentation:
Selatogrel, a novel P2Y 12 inhibitor for emergency use, achieves rapid,
consistent and sustained platelet inhibition following single-dose subcutaneous
administration in stable CAD patients.
Session: New Developments in Anti Thrombotic Drug Therapy, 2349.
Robert Storey, Paul Gurbel, Stefan James, Jurrien ten Berg, Jean-Francois
Tanguay, Corine Bernaud, Jean-Marie Frenoux, Abdel Hmissi, Mike Ufer, Pim Van
der Harst, Arnoud Van't Hof, George Dangas, Vijay Kunadian, Diana Gorog,
Dietmar Trenk, Dominick Angiolillo.
Sunday, September 1, 2019, 17:15 - 17:32

Oral presentation:
Inhibition of platelet aggregation after subcutaneous administration of a
single-dose of selatogrel, a novel P2Y 12 antagonist, in acute myocardial
infarction: A randomised open-label phase 2 study.
Session: Emerging Treatments in Acute Coronary Syndromes, 5232.
Peter Sinnaeve, Gregor Fahrni, Dan Schelfaut, Alessandro Spirito, Christian
Mueller, Jean-Marie Frenoux, Abdel Hmissi, Corine Bernaud, Mike Ufer, Tizziano
Mocetti, Shaul Atar, Marco Valgimigli.
Tuesday, September 3, 2019, 11:34 - 11:48

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 750 highly qualified specialists dedicated to realizing our
ambitious targets.

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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