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03.10.2022 - 07:00

GlobeNewswire: Idorsia Japan announces positive results with daridorexant in a Phase 3 study of Japanese patients with insomnia

Idorsia Japan announces positive results with daridorexant in a Phase 3 study
of Japanese patients with insomnia

Ad hoc announcement pursuant to Art. 53 LR Daridorexant demonstrated
significant improvement in the subjective measures of Total Sleep Time (sTST)
and Latency for Sleep Onset (sLSO) in Japanese patients with insomnia Idorsia
Japan expects to file a New Drug Application (NDA) with the Japanese Ministry
of Health Labor and Welfare (MHLW) in the first half of 2023

Allschwil, Switzerland , and Tokyo, Japan - October 3 , 2022
Idorsia Ltd (SIX: IDIA) and Idorsia Pharmaceuticals Japan today announced
positive top-line results of the Japanese Phase 3 study investigating 25 and 50
mg doses of Idorsia's dual orexin receptor antagonist, daridorexant, in 490
randomized adult and elderly patients (30.1% ≥ 65 years) with insomnia
disorder. In general, the results are in-line with the safety and efficacy
profile of daridorexant as reported in The Lancet Neurology.

The study was a randomized, double-blind, placebo-controlled, Phase 3 study to
investigate the efficacy and safety of daridorexant. Patients were randomized
to receive 50 or 25 mg doses of daridorexant or placebo once daily for 28 days.

The study met both primary and secondary efficacy endpoint measures.
Daridorexant significantly improved sTST from baseline compared to placebo at
28 days (p < 0.001 for 50 mg, p=0.042 for 25 mg). Daridorexant also
significantly improved sleep onset as measured by a decrease in sLSO from
baseline compared to placebo at 28 days (p < 0.001 for 50 mg, p=0.006 for
25 mg).

The rate of adverse events was comparable between placebo and daridorexant at
both treatment doses. Treatment-emergent adverse events (TEAEs) during the
double-blind study period were reported in 23.5% and 22.7%of the patients
treated with 50 and 25 mg daridorexant, respectively (24.4% for placebo). The
most frequent TEAEs reported over 3% incidence and higher than placebo were
somnolence (6.8% and 3.7% for daridorexant 50 mg and 25 mg groups respectively,
versus 2.4% in the placebo group), and pyrexia (0.6% and 3.7% for daridorexant
50 mg and 25 mg groups respectively, versus 1.2% in the placebo group).

Makoto Uchiyama, M.D., Ph.D., medical advisor of the Japanese Phase 3 study ,
Director of Tokyo Adachi Hospital , Visiting Professor of Nihon University ,
and Visiting Professor of Toho University commented:
"Insomnia is highly prevalent in Japan and is recognized as an important
national health issue. Patients with insomnia have trouble falling or staying
asleep, as well as waking up earlier than desired, all of which lead to
detrimental effects on both physical and mental health. This Phase 3 trial
showed that daridorexant increased total sleep time and shortened sleep latency
in patients with insomnia without marked hangover symptoms the next morning
which clearly indicates its potency to improve core symptoms of insomnia. Such
a promising outcome was likely due to the unique characteristics of the drug, a
dual orexin receptor antagonist with an optimal elimination half-life."

Satoshi Tanaka, Dr Med Sci. and President of Idorsia Pharmaceuticals Japan,
"I want to say thank you to the patients who participated in the study, and
the investigators and their staff for their dedication to running the study to
a high quality. The Idorsia Japan team will now fully analyze the study data
and I look forward to sharing the wealth of data generated with daridorexant
with Japanese health authorities in the form of a new drug application for
marketing authorization in Japan. Together with our partner Mochida, the whole
team is eager to rapidly make daridorexant available to Japanese patients with

About the Japanese Phase 3 study
The Japanese Phase 3 study was a randomized, double-blind, placebo-controlled,
parallel-group, multicenter study to investigate the efficacy and safety of
daridorexant in patients with insomnia disorder. The primary objective of the
study was to demonstrate the efficacy of 50 mg of daridorexant once daily at
bedtime versus placebo for 4 weeks in patients with insomnia disorder. The
efficacy of daridorexant was measured by patient reported total sleep time and
latency to sleep onset. The primary efficacy endpoint was change from baseline
to Week 4 in sTST and change from baseline to Week 4 in sLSO with 50 mg
daridorexant versus placebo. The secondary efficacy endpoint was change from
baseline to Week 4 in sTST and change from baseline to Week 4 in sLSO with 25
mg daridorexant versus placebo. The study also evaluated the dose effect of 50
or 25 mg of daridorexant versus placebo using other patient reported sleep
measures. The study enrolled 490 patients, randomized 1:1:1 to daridorexant
50, 25 mg or placebo. As insomnia often presents later in life, and older
adults are more susceptible to experience fragmented sleep, early awakening,
and daytime sleepiness, around 30% of the recruited population was at least 65
years of age. A long-term treatment safety study of 12-month duration is
expected to deliver results before the end of the year.

About the license agreement in Japan
In December 2019, Idorsia and Mochida Pharmaceutical Co., Ltd. entered into an
exclusive license agreement for the supply, co-development and co-marketing of
daridorexant for insomnia and related disorders in Japan.

Global r egulatory status of daridorexant
In January 2022, QUVIVIQ (daridorexant) was approved by the US Food and Drug
Administration (FDA) and subsequently made commercially available in May 2022.
In April 2022, marketing authorization of QUVIVIQ was granted by the European
Commission and subsequently by the Medicines and Healthcare products Regulatory
Agency (MHRA) in Great Britain via the European Commission Decision Reliance
Procedure. Launch preparations are underway in the major European markets with
the first launch expected before the end of the year. Daridorexant is currently
under review with Swissmedic and Health Canada.

Notes to the editor

About insomnia disorder
Insomnia disorder is defined as difficulty initiating or maintaining sleep,
causing clinically significant distress or impairment in important areas of
daytime functioning. This impact on sleep quantity or quality should be present
for at least three nights per week, lasts for at least three months, and occurs
despite an 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. According to Japan Preventive Association of
Life-style Related Disease, Insomnia is a common problem with an estimated
prevalence in Japan of 20% of the adult population.

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 goal of treatments for insomnia is to improve sleep quality and quantity,
as well as daytime functioning, while avoiding adverse events and next-morning
residual effects. Current recommended treatment of insomnia includes sleep
hygiene therapy, cognitive behavioral therapy, and pharmacotherapy.

About the orexin system
Wake and sleep signaling 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 (serotonin, histamine,
acetylcholine, norepinephrine) - to 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 t he global daridorexant Phase 3 registration program (outside of Japan)
The global Phase 3 registration program comprised two double-blind three-month
studies, together with a long-term double-blind extension study. The program
enrolled a total of 1,854 patients with insomnia disorder. As insomnia often
presents later in life, and older adults are more susceptible to experience
fragmented sleep, early awakening, and daytime sleepiness, around 40% of the
recruited population was at least 65 years of age.

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 developed and validated according to
the FDA Guidance for Industry.

More than 800 patients continued treatment in the 40-week extension study,
which measured the effect of all three doses vs. placebo, generating data for
long-term treatment of insomnia disorder.

Phase 3 data has been reported in The Lancet Neurology: The pivotal studies
demonstrated that daridorexant 50 mg significantly improved sleep onset, sleep
maintenance and self-reported total sleep time at months one and three compared
to placebo. The largest effect was observed with the highest dose (50 mg),
followed by 25 mg, while the 10 mg dose did not have a significant effect. In
all treatment groups the proportions of sleep stages were preserved, in
contrast to findings reported with benzodiazepine receptor agonists.

A major focus of the trials was to evaluate the impact of daridorexant on
daytime functioning in patients with insomnia disorder, as assessed by the
IDSIQ. IDSIQ is a patient-reported outcomes instrument specifically developed
and validated according to FDA guidelines, to measure daytime functioning in
patients with insomnia. The sleepiness domain score of the IDSIQ was evaluated
as a key secondary endpoint in both pivotal studies and comparisons to placebo
included type I error control for multiplicity. Daridorexant 50 mg demonstrated
highly statistically significant improvement in daytime sleepiness at month one
and month three. The sleepiness domain score was not significantly improved on
25 mg in either study at either timepoint.

The overall incidence of adverse events was comparable between treatment
groups. The most frequently reported adverse reactions were headache and
somnolence and, overall, the majority of adverse reactions were mild to
moderate in intensity. There was no evidence of dose-dependent increases in
adverse events across the dosing range. Further, no dependence, rebound
insomnia or evidence of abuse or withdrawal symptoms indicative of physical
dependence upon treatment discontinuation was observed in clinical studies.

About Makoto Uchiyama, M.D. , Ph.D.
Director, Tokyo Adachi Hospital, Tokyo
Visiting Professor, Departments of Psychiatry and Sleep Medicine, Nihon
University School of Medicine, Tokyo
Visiting Professor, Department of Psychiatry, Toho University School of
Medicine, Tokyo

Educational Achievements and certificates:
M.D., Tohoku University, School of Medicine, Sendai, 1980
Ph.D., Tokyo Medical and Dental University, Tokyo, 1994
Designated Physicians of Mental Health, Ministry of Health, Labor and Welfare,
Certified Sleep Physician, Japanese Society of Sleep Research, 2002
Certified Psychiatrist, Japanese Society of Neurology and Psychiatry, 2006
Certified Electroencephalographer, Japanese Society of Clinical
Neurophysiology, 2006

Dr Uchiyama serves as a consultant to Idorsia.

Key literature Riemann, D., et al. Sleep. 2017;26(6):675-700. The Diagnostic
and Statistical Manual of Mental Disorders (5th ed.; DSM-5; American
Psychiatric Association, 2013). Wardle-Pinkston S., et al. Sleep Med Rev.
2019;48. Mignot, E., et al. Lancet Neurol. 2022;21:125-39. Muehlan, C., et al.
Expert Opin. Drug Metab. Toxicol. 2020;16(11):1063-1078. Muehlan, C., et al. J
Psychopharmacol. 2020;34(3):326-335. Buysse, D.J., et al. Drug Discov Today Dis
Models. 2011;8(4):129-137. Levenson, J.C., et al. Chest. 2015;147(4):1179-1192.
Boof, M.L., et al. Eur J Clin Pharmacol. 2019;75(2):195-205. Clifford, B.S., et
al. Trends Neurosci. 2001;24(12).726-31. Gotter, A.L., et al. BMC Neuroscience.
2013;14(1):14-19. Patel, D., et al. J Clin Sleep Med. 2018;14(06):1017-1024.
Hudgens, S., et al. Patient. 2020. doi:10.1007/s40271-020-00474-z.

IDSIQ © 2020, University of Pittsburg. All rights reserved. IDSIQ-14
derivative created 2020 by Idorsia Pharmaceuticals Ltd under license and
distributed by Idorsia Pharmaceuticals Ltd under license. IDSIQ is further a
registered trademark of Idorsia Pharmaceuticals Ltd.

About Mochida
Mochida Pharmaceutical Co., Ltd. has been committed to research and
development of innovative pharmaceutical products since its establishment
thereby providing distinctive medicines to the medical field. Currently, the
core pharmaceutical business focuses resources on the targeted areas of
cardiovascular medicine, obstetrics and gynecology, psychiatry and
gastroenterology, while also providing medicine for intractable disease as well
as generics including biosimilars, to meet medical needs. For more information
on Mochida Pharmaceutical Co., Ltd., please see

About Idorsia Pharmaceuticals Japan
Idorsia Pharmaceuticals Japan was established, under the leadership of Dr
Satoshi Tanaka, in 2018 to conduct clinical development and prepare the
commercialization of Idorsia's innovative and promising compounds for patients
in Japan.

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 1,200 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 - media.relations@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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