ACT-541468 (DORA) meets primary endpoint in Phase 2 program in adult and elderly patients with insomnia

(Thomson Reuters ONE) -
Idorsia Pharmaceuticals Ltd. /
ACT-541468 (DORA) meets primary endpoint in Phase 2 program in adult and elderly
patients with insomnia
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Source: Globenewswire

* Results show desired effect on sleep maintenance and onset - significant
dose-response relationship
* Idorsia to advance ACT-541468 (DORA) into confirmatory Phase 3 program
Allschwil, Switzerland - 28 July 2017 - Idorsia Ltd (SIX: IDIA) today announced
positive results for the comprehensive Phase 2 program with the dual orexin
receptor antagonist ACT-541468 (DORA) in insomnia, with zolpidem as an active
reference. The program comprised two placebo-controlled dose-response studies to
evaluate the safety and efficacy of ACT-541468 in adult and elderly patients
with insomnia, with a total of 418 patients participating in the trials.

Martine Clozel, MD and Chief Scientific Officer of Idorsia, commented: "Our
scientists have been true pioneers in the field of orexin antagonism. More than
20000 compounds were synthesized and studied before ACT-541468 was selected. Its
discovery is the result of an extensive effort to combine two important
characteristics of a sleep medication: maintaining efficacy throughout the
night, and a low potential for a next-day residual effect. I am delighted to see
that the positive readouts from this comprehensive Phase 2 program are
consistent with our preclinical predictive models, for both adult and elderly
patients with insomnia."

The first study in 360 adults (ranging from 18 to 64 years) with a treatment
duration of 4 weeks showed a significant dose-dependent decrease in WASO at Day
1 & 2 (average decrease of wake time after sleep onset from baseline on the

first 2 nights of treatment, measured by polysomnography). In addition, ACT-
541468 significantly decreased LPS (latency to persistent sleep) in a dose-
dependent manner.

Treatment with ACT-541468 was generally well tolerated. There were no reports of
serious adverse events related to ACT-541468.

The positive readouts of a second study, conducted in 58 elderly patients
(ranging from 65 to 85 years), confirmed the efficacy and safety profile of ACT-
541468 in this population. The results of this study also showed a significant
decrease in WASO and LPS at Day 1 & 2 in a dose-dependent manner.

The overall results of the Phase 2 program with ACT-541468 in insomnia support
the decision to initiate efficacy and safety confirmatory studies in both adult
and elderly patients.

Detailed results of the Phase 2 program will be made available through
scientific disclosure at upcoming congresses and in peer-reviewed publications.

Guy Braunstein, MD and Head of Global Clinical Development of
Idorsia, commented: "The positive results of the Phase 2 program demonstrate
that our DORA can deliver on the potential its mechanism of action offers in
insomnia. We have observed a fast onset of sleep and a duration of action which
does not exceed a normal night's sleep. We will now consult with health
authorities and progress this important asset into the Phase 3 program as
quickly as possible."

Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia, commented: "We
couldn't have asked for a better start for Idorsia. First the excellent results
with aprocitentan, where we are in discussions with health authorities to move
into Phase 3 for development in resistant hypertension, and now our dual orexin
receptor antagonist moving into Phase 3 for insomnia. This will take us an
important step closer to delivering on one of our major strategic objectives -
to bring at least three products to market within the next 5 years that have the
potential to substantially change the treatment options in their target
disease."

***

Notes to the editor

About ACT-541468 (DORA)

ACT-541468 is a dual orexin receptor antagonist (DORA) which targets the orexin
system and is intended to treat insomnia. Based on preclinical data, dual orexin
receptor antagonism maintains natural sleep architecture. Preclinical data
suggests that ACT-541468 will have a low potential for abuse. Data from a
comprehensive Phase 1 program indicates that ACT-541468 has a suitable
pharmacokinetic and pharmacodynamic profile to deliver fast onset of sleep, a
duration of action which is well suited for appropriate sleep maintenance, and
low potential for next day residual effect. These properties are being explored
clinically and, if confirmed, will give ACT-541468 the potential to be
differentiated from current sleep medications, for the benefit of patients.

About Orexins

Orexins are neuropeptide modulators - small protein-like molecules used by nerve
cells (or neurons) to communicate with each other in the brain. Orexins act
functionally at the interface of alertness, energy homeostasis and reward:
aversion systems, essentially to regulate vigilance and alertness states.
Defects of the orexin peptides, or their receptors, are associated with
wakefulness and sleep disorders.

The anatomical distribution of orexin receptors in the brain supports the
essential role that orexin plays in promoting alertness and maintaining
wakefulness under situations of high motivational relevance, e.g. circadian
vigilance states, reward opportunities or exposure to threats. Orexins and their
receptors are highly conserved across vertebrate species.

About Insomnia

Insomnia is defined as a combination of both dissatisfaction with sleep and a
significant negative impact on daytime functioning. Dissatisfaction with sleep
describes the difficulty to initiate and/or maintain sleep on at least three
nights per week for at least three months, despite adequate opportunity to
sleep.

Insomnia is, worldwide, the most commonly reported sleeping disorder. By 2020,
it is estimated that there will be approximately 13 million insomnia patients
being treated with pharmaceutical-grade insomnia medications in the US alone,
according to research by GlobalData Ltd in 2015.

Lack of sleep can have a significant negative impact on daytime functioning,
physical and mental health. This can include fatigue, daytime sleepiness, poor
concentration, depressed mood, or impaired ability to perform social or
occupational tasks.

The goal of treatments for insomnia is to improve sleep quality and quantity, as
well as reducing insomnia-related daytime impairments, while being safe and
devoid of any next morning residual effect. Current treatment of insomnia
includes cognitive behavioral therapy, sleep hygiene recommendations, and
pharmacotherapy. Most sleep disorder products on the market enhance the effects
of gamma-aminobutyric acid (GABA), the major inhibitory neurotransmitter in the
central nervous system. Such medications are associated with side effects such
as next-day effects, anterograde amnesia, and risk of tolerance and dependence.

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 intend to develop Idorsia into Europe's leading
biopharmaceutical company, 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 600 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 58 844 10 10
www.idorsia.com

Press release PDF:
http://hugin.info/174259/R/2123726/810306.pdf



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Source: Idorsia Pharmaceuticals Ltd. via GlobeNewswire

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Datum: 28.07.2017 - 07:00 Uhr
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News-ID 1515295
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