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IDORSIA LTD

(IDIA)
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GlobeNewswire/Idorsia to present new Phase 3 data on daridorexant in insomnia at SLEEP 2021

09.06.2021 | 07:00
   Allschwil, Switzerland -- June 9, 2021 
 
   Idorsia Ltd (SIX: IDIA) today announced that nine abstracts for 
daridorexant, the company's investigational dual orexin receptor 
antagonist for the treatment of adults with insomnia, will be presented 
at SLEEP 2021. The annual joint meeting of the American Academy of Sleep 
Medicine and the Sleep Research Society is conducted virtually from June 
10-13. 
 
   Antonio Olivieri, Senior Vice President, Head of Global Medical Affairs 
of Idorsia commented: 
 
   "As a company with a strong scientific core rooted in innovative small 
molecules, Idorsia aims to transform the horizon of therapeutic options. 
We look forward to presenting new data from our Phase 3 clinical program 
and other important new data on daridorexant. This reflects our 
commitment to advance research for insomnia, a condition that can 
substantially impact the physical and mental health of patients and 
remains an area with great unmet need." 
 
   Posters for daridorexant include the following: 
 
 
   -- Fietze I, et al. Daridorexant is safe and improves both sleep and daytime 
      functioning in elderly patients with insomnia. [347] 
 
   -- Leger D, et al. Absence of Withdrawal Symptoms and Rebound Insomnia Upon 
      Discontinuation of Daridorexant in Patients with Insomnia. [348] 
 
   -- Zammit G, et al. Daridorexant Improves Total Sleep Time (TST) in Insomnia 
      Patients Without Altering the Proportion of Sleep Stages. [344] 
 
   -- Heidenreich S, et al. A benefit-risk assessment of daridorexant for the 
      treatment of insomnia using patient preference data from two phase 3 
      trials. [343] 
 
   -- Roch C, et al. Daridorexant, a dual orexin receptor antagonist, improves 
      age-related insomnia in rats. [002] 
 
   -- Bergamini G, et al. Effect of the dual orexin receptor antagonist (DORA) 
      daridorexant on behaviour upon awakening in rats and dogs. [09] 
 
   -- Grandjean CM, et al. A dual, equipotent, and insurmountable antagonist of 
      both orexin-1 and orexin-2 receptors. [059] 
 
   -- Boof ML, et al. Daridorexant Does Not Impair Respiratory Function in 
      Patients with Mild/Moderate Obstructive Sleep Apnea Irrespective of 
      Severity. [357] 
 
   -- Boof ML, et al. Daridorexant Improves Sleep in Patients with 
      Mild/Moderate Obstructive Sleep Apnea. [358] 
 
 
   The abstracts can be found in the SLEEP 2021 Abstract 
https://www.sleepmeeting.org/abstract-supplements/ supplement 
https://www.sleepmeeting.org/abstract-supplements/ . 
 
   Daridorexant is currently investigational and is not approved for any 
use anywhere in the world. In March, the US Food and Drug Administration 
(FDA) accepted a new drug application (NDA) for review of daridorexant 
for the treatment of adult patients with insomnia. Idorsia has also 
submitted marketing authorization applications (MAA) to the European 
Medicines Agency and Swissmedic for daridorexant for the same 
indication. 
 
   Notes to the editor 
 
   About insomnia 
 
   Insomnia is defined as a combination of dissatisfaction with sleep and a 
significant negative impact on daytime functioning. Dissatisfaction with 
sleep refers to 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 a condition of overactive wake signaling and studies have 
shown that areas of the brain associated with wakefulness remain more 
active during sleep in patients with insomnia. 
 
   Insomnia is a common problem with a prevalence of approximately 10%. On 
this basis, and assuming a US adult population of around 250 million, 
there are approximately 25 million adults in the US who suffer from 
insomnia. 
 
   Insomnia as a disorder is quite different from a brief period of poor 
sleep, and it can take its toll on both physical and mental health. It 
is a persistent condition with a negative impact on daytime functioning. 
Idorsia's research has shown that poor-quality sleep can affect many 
aspects of daily life, including the ability to concentrate, mood, and 
energy levels. 
 
   The goals of managing insomnia are to improve sleep quality and quantity, 
as well as daytime functioning. Current recommended treatment of 
insomnia includes sleep hygiene recommendations, cognitive behavioral 
therapy and pharmacotherapy. 
 
   About the orexin system 
 
   Wake and sleep signalling is regulated by intricate neural circuitry in 
the brain. One key component of this process is the orexin system, which 
helps promote wakefulness. There are two forms of orexin neuropeptides 
-- small protein-like molecules used by nerve cells (neurons) to 
communicate with each other in the brain -- orexin A and orexin B. 
Orexin promotes wakefulness through its receptors OX1R and OX2R. 
Together, these neuropeptides and receptors make up the orexin system. 
The orexin system stimulates targeted neurons in the wake system -- 
leading to the release of several chemicals (dopamine, serotonin, 
histamine, acetylcholine, norepinephrine) which promote wakefulness. 
Under normal circumstances, orexin levels rise throughout the day as 
wakefulness is promoted and then fall at night. Overactivity of the wake 
system is an important driver of insomnia. 
 
   About daridorexant 
 
   Daridorexant is an investigational dual orexin receptor antagonist 
(DORA) designed and developed for the treatment of insomnia. 
Daridorexant reduces overactive wakefulness associated with insomnia by 
blocking the activity of orexin. DORAs specifically target the orexin 
system by competitively binding with both receptors, thereby reversibly 
blocking the activity of orexin. Blocking orexin receptors reduces the 
downstream activity of the wake-promoting neurotransmitters that are 
overactive in insomnia. 
 
   About the registration program 
 
   The Phase 3 registration program comprised two three-month studies, 
together with a long-term double-blind extension study. Both pivotal 
studies are complete, having enrolled around 1,850 patients with 
insomnia at over 160 sites across 18 countries. As insomnia often 
presents later in life, and elderly patients are more susceptible to 
fragmented sleep, early awakening and daytime sleepiness, around 40% of 
the recruited population was aged 65 years or older. The 
placebo-controlled studies investigated the effects of three doses of 
daridorexant (10 mg, 25 mg, and 50 mg) on sleep and daytime functioning 
parameters, objectively in a sleep lab by polysomnography and 
subjectively with a daily patient diary at home. The impact of insomnia 
on patients' daytime functioning was measured daily using the sleepiness 
domain score from the Insomnia Daytime Symptoms and Impacts 
Questionnaire (IDSIQ) -- a patient-reported outcome (PRO) instrument 
validated according to FDA industry guidance. Both Phase 3 studies met 
their primary endpoints and the results were first presented in a 
late-breaking oral presentation at the Associated Professional Sleep 
Societies (APSS) SLEEP 2020 medical congress in August 2020. 
 
   More than 800 patients continued treatment into a 40--week extension 
study, which measured the effects of all three doses vs placebo, 
generating data for long-term treatment of insomnia. 
 
   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 a leading biopharmaceutical company, 
with a strong scientific core. 
 
   Headquartered near Basel, Switzerland -- a European biotech-hub -- 
Idorsia is specialized in the discovery, development and 
commercialization of small molecules to transform the horizon of 
therapeutic options. Idorsia has a broad portfolio of innovative drugs 
in the pipeline, an experienced team of professionals covering all 
disciplines from bench to bedside, state-of-the-art facilities, and a 
strong balance sheet -- the ideal constellation to translate R&D efforts 
into business success. 
 
   Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in 
June 2017 and has over 900 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 
 
   investor.relations@idorsia.com 
 
   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 
      https://ml-eu.globenewswire.com/Resource/Download/057ab77a-4ed9-4259-80e0-98da46fa0832 
 
 
 
 
 
 
 

(END) Dow Jones Newswires

June 09, 2021 01:00 ET (05:00 GMT)

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Vorstände und Aufsichtsräte
Jean-Paul Clozel Chief Executive Officer & Director
André C. Muller Chief Financial Officer & Executive Vice President
Mathieu Simon Chairman
Guy Braunstein Executive VP & Head-Global Clinical Development
Martine Clozel Chief Scientific Officer & Executive VP
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