31.08.2019 - 12:00

GlobeNewswire: Phase 2 data of aprocitentan, Idorsia’s dual endothelin receptor antagonist, presented at ESC 2019

Phase 2 data of aprocitentan, Idorsia's dual endothelin receptor antagonist,
presented at ESC 2019 Phase 2 dose-finding study demonstrated the blood
pressure lowering effect of aprocitentan A global Phase 3 study "PRECISION" in
patients whose blood pressure remains uncontrolled despite receiving at least
three antihypertensive medications is ongoing As part of the Phase 3 program,
the company is initiating an additional study "INSPIRE-CKD" for the treatment
of patients with uncontrolled blood pressure and chronic kidney disease stage 3
or 4

Allschwil, Switzerland - August 31, 2019
Idorsia Ltd (SIX: IDIA) today announced that the results of the Phase 2 study
with aprocitentan were presented at the European Society of Cardiology (ESC)
2019 Congress in Paris, France.

Hypertension (high blood pressure) is one of the most common cardiovascular
risks, and its prevalence continues to rise. According to a recent study, there
are more than 1 billion people living with hypertension worldwide. Left
uncontrolled, hypertension can lead to life-threatening conditions such as
stroke, ischemic heart disease, or kidney disease.

Aprocitentan is an orally active dual endothelin receptor antagonist (ERA).
Aprocitentan at doses of 12.5 and 25 mg is currently being investigated for the
treatment of patients whose blood pressure is uncontrolled despite receiving
triple antihypertensive medications (categorized as resistant hypertension) in
a global Phase 3 registration study, "PRECISION". The doses were selected based
on a Phase 2 dose-finding study which evaluated the efficacy, safety and
tolerability of a once-a-day oral regimen of four dose levels of aprocitentan
in patients with essential hypertension. Results of this Phase 2 study were
presented at ESC Congress 2019.

Phase 2 study in adults with essential hypertension presented at ESC
Parisa Danaietash, PhD from Idorsia gave an oral presentation entitled " E
fficacy and safety of various doses of the new dual endothelin receptor
antagonist aprocitentan in the treatment of hypertension".

Eligible patients with hypertension (mean sitting systolic/diastolic blood
pressure 149.7/97.6 mmHg) received aprocitentan 5, 10, 25 or 50 mg, matching
placebo or lisinopril 20 mg as a positive control, once daily for 8 weeks using
a randomized, double-blind, parallel-group study design. Blood pressure was
measured at baseline and weeks 2, 4, 8, and 10 (withdrawal) with an automated
office blood pressure (AOBP) device, which recorded and averaged multiple blood
pressure readings while the patient was unattended and resting quietly.

A total of 490 eligible patients were randomized, with 430 patients
successfully completing the double-blind treatment period. Decreases in sitting
systolic/diastolic AOBP, from baseline to week 8 were 10.3/6.3, 15.0/9.9,
18.5/12.0 and 15.1/10.0 mmHg for aprocitentan 5, 10, 25, and 50 mg,
respectively vs. 7.7/4.9 mmHg for placebo and 12.8/8.4 mmHg for lisinopril. No
changes in heart rate or body weight were observed for any dose of

Estimated increases in plasma volume were 3.0%, 5.1%, 6.9%, and 9.5% for
aprocitentan 5, 10, 25, and 50 mg, respectively, vs. 1.6% for lisinopril and a
decrease of 0.3% for placebo. All these values are within the physiological
variation range, i.e. below 10%. There was an expected dose-related decrease
from baseline in the hemoglobin concentration in the aprocitentan groups
(ranging from 1.3 to 6.7 g/L), versus increases of 2.2 and 0.1 g/L in the
placebo and lisinopril groups, respectively.

The overall incidence of adverse events observed in the aprocitentan groups
(ranging from 22.0% to 40.2%) was similar to that seen in the placebo group
(36.6%). Overall, the most common events were hypertension, headache, and

This study formed the basis for the ongoing Phase 3 investigation of
aprocitentan as a potential treatment for patients whose blood pressure is
uncontrolled despite receiving triple antihypertensive medications, conducted
in collaboration with Janssen Biotech, Inc.

Guy Braunstein, MD and Head of Global Clinical Development, commented:
"The results of the Phase 2 study show a dose-dependent blood pressure
lowering effect of aprocitentan and led to the selection of two doses, 12.5 and
25 mg, for further development. In our ongoing Phase 3 study, we investigate
the effect of aprocitentan in patients with uncontrolled hypertension despite
standardized triple background therapy. If successful, aprocitentan may become
a new treatment for patients whose blood pressure is difficult to control with
a combination of current medications, which represents an important medical
need. This is very exciting since no antihypertensive medication working via a
new pathway, and no ERA has reached this market within the last 30 years."

Idorsia is initiating an additional blinded, randomized, placebo-controlled,
Phase 3 study with aprocitentan in patients with chronic kidney disease (CKD)
stage 3 or 4 whose blood pressure remains uncontrolled despite the use of at
least two antihypertensive medications. The primary objective of this study is
to demonstrate the safety and blood pressure lowering effect of 4-weeks'
treatment with aprocitentan when added to background antihypertensive therapy.
The study is expected to commence enrolment in the first quarter of 2020, will
enroll about 200 patients in approximately 100 sites from around 15 countries,
and will last for about two years.

Notes to the editor

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 triple combination of a calcium channel blocker
(amlodipine), an angiotensin receptor blocker (valsartan), and a diuretic

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 after 4
weeks, compared to placebo. Patients then enter a treatment period where they
receive aprocitentan 25 mg for 32 weeks. This is followed by a randomized
double-blind 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

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.

About the collaboration Agreement with Janssen Biotech, Inc.
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
Biotech, Inc. will oversee the Phase 3 development and submission for any
additional indications.

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

The above information contains certain "forward-looking statements", relating
to the company's business, which can be identified by the use of
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"are expected to", "will", "will continue", "should", "would be", "seeks",
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company's investment and research and development programs and anticipated
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be introduced by the company and anticipated customer demand for such products
and products in the company's existing portfolio. Such statements reflect the
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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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