Idorsia's P2Y12 receptor antagonist - selatogrel - Phase 2 clinical studies meet their
objective


Idorsia Pharmaceuticals Ltd. /
Idorsia's P2Y12 receptor antagonist - selatogrel - Phase 2 clinical studies meet 
their objective 
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Source: Globenewswire


Allschwil, Switzerland - December 18, 2018
Idorsia Ltd (SIX: IDIA) today announced that Phase 2 clinical studies with
selatogrel (recommended INN for ACT-246475), Idorsia's P2Y12 receptor
antagonist, in patients with stable coronary artery disease (CAD) and patients
with acute myocardial infarction (AMI) have met their pharmacodynamic objectives
of significantly inhibiting platelet aggregation.

Subcutaneous administration of selatogrel 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.

The company is now preparing for the end of Phase 2 meetings with Health
Authorities where it will discuss the Phase 3 study. Results of the studies will
be shared at upcoming scientific congress and published in scientific
literature.





Notes to the editor

Phase 2 study in adults with stable CAD
Idorsia has completed a multicenter, double blind, randomized, placebo-
controlled study assessing the pharmacodynamics, pharmacokinetics, tolerability
and safety of a single subcutaneous injection of selatogrel in adults with
stable coronary artery disease. In this study, 346 patients receiving
conventional background oral antiplatelet therapy (e.g. acetylsalicylic acid,
P2Y12 receptor antagonists) were randomized to receive either selatogrel
8mg, 16 mg or placebo. The primary objective of the study was to characterize
inhibition of platelet aggregation relative to placebo after a single
subcutaneous injection of selatogrel either in the thigh or in the abdomen at 2
different doses in patients with stable CAD.

Phase 2 study in adults with AMI
Idorsia has also completed a multi-center, open-label, randomized, exploratory
study to assess the onset of platelet aggregation inhibition after a single
subcutaneous injection of selatogrel in adults with acute myocardial infarction.
In this study, 48 patients with confirmed diagnosis of AMI and time from onset
of symptoms of more than 30 min and less than 6 hours were randomized to receive
either selatogrel 8 mg or 16 mg in addition to conventional antithrombotic
treatment (e.g., acetylsalicylic acid, oral P2Y12 receptor antagonists,
anticoagulants). The primary objective of the study was to assess the inhibition
of platelet aggregation 30 minutes after a single subcutaneous injection of
selatogrel in patients with AMI.


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 700 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



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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.

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Source: Idorsia Pharmaceuticals Ltd. via GlobeNewswire