Daridorexant Phase 3 results in insomnia presented at SLEEP 2020


Allschwil, Switzerland – August 28, 2020

Idorsia Ltd (SIX: IDIA) today announced that the positive results from the first pivotal Phase 3 study (evaluating 25 and 50 mg doses) of its investigational dual orexin receptor antagonist, daridorexant, in adult and elderly patients with insomnia, were presented by Dr Thomas Roth at SLEEP 2020. The study demonstrated efficacy of treatment with daridorexant on objective and subjective sleep parameters, and daytime functioning, with no next-morning residual effect.

The Associated Professional Sleep Societies (APSS) event, SLEEP 2020, is the world’s largest meeting devoted entirely to clinical sleep medicine, and sleep and circadian research and is currently taking place as a virtual meeting. The presentation, entitled “Efficacy and safety of daridorexant in adult and elderly patients with insomnia”, is available for on-demand replay for registered participants through August 1, 2021.

Dr Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at Henry Ford Hospital, commented:
“Daridorexant, a new dual orexin receptor antagonist, has a pharmacokinetic and pharmacodynamic profile optimized for sleep onset and duration of action to improve night-time efficacy, without residual effects. These pharmacological properties led us to hypothesize that daridorexant could also improve the impaired daytime functioning frequently observed in insomnia. A new patient-reported outcome instrument was developed – and validated according to FDA requirements – to specifically assess daytime functioning in patients with insomnia and we included it in the Phase 3 program. The results have been outstanding.”

The Phase 3 trial was designed to measure the impact of daridorexant on objective and subjective sleep parameters as well as on daytime functioning, and to evaluate safety, in patients with moderate to severe insomnia. Sleep variables were assessed using polysomnography for wake after sleep onset (WASO) and latency to persistent sleep (LPS). A sleep diary questionnaire was used to measure subjective total sleep time (sTST). Daytime functioning was assessed using a newly developed and validated patient-reported outcome instrument, the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). The IDSIQ comprises 14 items grouped into three domains that reflect daytime effects of insomnia that are commonly encountered in clinical practice: Alert/Cognition, Mood, and Sleepiness/Tiredness.

Daridorexant significantly improved sleep maintenance as measured by a larger decrease in WASO from baseline compared to placebo. The mean change from baseline in WASO (minutes) for placebo, 25 mg and 50 mg was -6.2, -18.4, and -29.0 at 1 Month and -11.1, -23.0 and -29.4 at 3 Months, respectively (all p values vs. placebo <0.0001).

Daridorexant significantly improved sleep onset as measured by a larger decrease in LPS from baseline compared to placebo. The mean change from baseline in LPS (minutes) for placebo, 25mg and 50mg was -19.9, -28.2 (p=0.0005) and -31.2 (p<0.0001) at 1 Month and, -23.1, -30.7 (p=0.0015) and -34.8 (p<0.0001) at 3 Months, respectively (p-values vs placebo).

Subjective total sleep time assessed daily by patients increased more with daridorexant from baseline compared to placebo. The mean change from baseline in sTST (minutes) for placebo, 25mg and 50mg was 21.6, 34.2 (p=0.0013), and 43.6 (p<0.0001) at 1 Month, and 37.9, 47.8 (p=0.0334), 57.7 (p<0.0001) at 3 Months, respectively (p-values vs placebo).

Daridorexant improved daytime functioning, as measured in a secondary efficacy endpoint by the Sleepiness/Tiredness domain of the IDSIQ. For this domain, the improved daytime functioning was demonstrated by a mean score reduction from baseline for placebo, 25mg and 50mg of -2.0,
-2.8 (p=0.0547) and -3.8 (p<0.0001) at 1 Month, and of -3.8, -4.8 (p=0.0534) and -5.7 (p=0.0002) at
3 Months, respectively (p-values vs placebo). In addition, other efficacy endpoints from the IDSIQ patient-reported outcome instrument, namely the “Alert/Cognition” domain, “Mood” domain, and the “Total IDSIQ” scores, consistently showed a dose-dependent improvement, as presented.

The most frequent AEs, nasopharyngitis and headache, were balanced between arms. Somnolence was reported in 6 (1.9%) patients on placebo, 11 (3.5%) patients on daridorexant 25mg, and 5 (1.6%) of patients on daridorexant 50mg.

The late breaking abstract (LBA 4) is available in the Virtual Sleep 2020 meeting guide.

Dr Roth concluded:
“As hypothesized, the optimized profile of daridorexant not only translated in this study into a dose-dependent improvement on objective and subjective sleep parameters, but also into improved daytime functioning, all of which was sustained over time. Very importantly, safety was comparable with daridorexant 25 mg and 50 mg, with no dose-limiting safety findings, no observed next-morning sleepiness compared to placebo, no signals suggestive of rebound insomnia compared to baseline sleep parameters, and no withdrawal effects. With these results daridorexant addresses important needs of patients with insomnia.”

The Phase 3 program design was also presented as a poster entitled “Daridorexant (ACT-541468), a dual orexin receptor antagonist, for the treatment of insomnia disorder: Phase 3 program for assessing efficacy and safety in adult and elderly patients”. The poster is available on demand to registered attendees of SLEEP 2020 and the abstract can be found in the Abstract Supplement.

In April and July 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia. More details and commentary can be found in the dedicated press releases (first study release), (second study release) and the investor webcasts (first study webcast), (second study webcast) which are available for replay on the corporate website.

Notes to the editor

About daridorexant
Daridorexant is a potent, selective, dual orexin receptor antagonist (DORA) currently in development for the treatment of insomnia. Orexin neurons are localized in the lateral hypothalamus and function as a key regulator of wakefulness, signaling other wake promoting neurons to be active, thus maintaining a "wake state". Insomnia is a condition of overactive wake signaling. Studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. Blocking the activity of orexin reduces the downstream activity of other wake promoting neurotransmitters, allowing sleep to occur. Daridorexant has a pharmacokinetic and pharmacodynamic profile that was tailored specifically for the treatment of insomnia, including fast absorption to support sleep onset, a half-life designed to promote sleep maintenance throughout the night and minimize the risk of relevant carry-over exposure in the morning, without accumulation over time.  Daridorexant has shown clinical efficacy in Phase 2 and 3 clinical studies and is expected to be submitted for regulatory review around the end of 2020.

About the Phase 3 registration program
The Phase 3 registration program comprises two confirmatory studies of 3-month duration, together with a long-term 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, around 40% of the recruited population was aged 65 years or older. The confirmatory multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography studies investigated 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 the US Food and Drug Administration (FDA) Guidance for Industry. 806 patients decided to continue treatment in the ongoing 40-week extension study which will measure the effect of all three doses vs. placebo, generating data for long-term treatment of insomnia.

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, worldwide, the most commonly reported sleep disorder and its impact is often underestimated. It can be a distressing condition that can impair quality of life. Sleepless nights can leave people feeling irritable and out of sorts – this may affect many aspects of daily life, from studying and employment to social activities and relationships. People who suffer from insomnia may lack the energy or motivation to exercise or to take part in social activities. It can also have a significant economic impact as it increases the risk of accident and injury on the road or in the workplace and is a leading cause of absenteeism and reduced productivity at work. People with insomnia are more likely to experience feeling down or depressed, lack concentration, and suffer from poor energy levels during the day compared with people who sleep well. In addition, worrying about sleep can cause stress and may lead to negative thought patterns which may in turn make it more difficult to sleep, setting up a vicious cycle. Chronic insomnia is associated with cardiovascular and cerebrovascular diseases, and increased mortality.

The goal of treatment for insomnia is to improve sleep quality and quantity, as well as to reduce insomnia-related impaired daytime functioning, while avoiding adverse events and next morning residual effects. Current treatment of insomnia includes cognitive behavioral therapy, sleep hygiene recommendations, and pharmacotherapy. The most widely prescribed products on the market that are indicated for insomnia enhance the effects of gamma-aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system. Such medications are only approved for short-term use and are associated with side effects such as next-day effects, anterograde amnesia, and risk of tolerance and dependence.

About Dr. Thomas Roth, PhD
Dr. Roth has been the Director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, since 1978. Dr. Roth is also a Professor in the Department of Psychiatry at Wayne State University, School of Medicine in Detroit, Michigan, and serves as a Clinical Professor in the Department of Psychiatry at the University of Michigan, College of Medicine in Ann Arbor.

After serving as president of the Sleep Research Society, and the founding president of the National Sleep Foundation (NSF), Dr. Roth became chairman of the National Center on Sleep Disorders Research advisory board. In addition, he was a member of the board of directors of the Associated Professional Sleep Societies (APSS), chaired the Association's Scientific Program Committee and the governing board of the World Federation of Sleep Research Societies.

Dr. Roth was instrumental in the formation of the Association of Sleep Disorders Center (ASDC) and served as the organization's second president. He is also the former Chairman of the World Health Organization's worldwide project on sleep and health. In addition to authoring and co-authoring numerous articles, Dr. Roth serves as past editor-in-chief of the journal Sleep. He currently sits on the editorial boards of Sleep Reviews, Stress Medicine, and Advances in Therapy and Human Psychopharmacology.

In 2002, Dr. Roth received the NSF's Lifetime Achievement Award for his accomplishments and contributions to sleep science, sleep medicine and public health. He received a Distinguished Research Award from the Sleep Research Society as well as the Nathanial Kleitman Award from the Academy of Sleep Medicine. Dr. Roth's contributions to the sleep field are expansive, ranging from prolific research productivity and scholarship to multiple national leadership positions, as well as the mentoring of many students and colleagues. Dr. Roth serves as a consultant to Idorsia.

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 800 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

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.


About GlobeNewswire

One Liberty Plaza - 165 Broadway
NY 10006 New York

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Huhtamaki publishes 2020 results on February 11, 202122.1.2021 10:00:00 CETPress release

HUHTAMÄKI OYJ PRESS RELEASE 22.1.2021 AT 11:00 Huhtamaki publishes 2020 Results on February 11, 2021 Huhtamäki Oyj will publish its 2020 Results on Thursday February 11, 2021 approximately at 8:30 Finnish time (CET +1). The report will be available on after publication, and the results presentation at 9:30 Finnish time (EET). Teleconference Huhtamaki will hold a combined audiocast and teleconference on the same day at 9.30 Finnish time. Huhtamaki´s President and CEO Charles Héaulmé and CFO Thomas Geust will present the results. The teleconference will be followed by a question and answer session. The event will be held in English, and it can be followed real-time at: If you wish to ask questions, please dial one of the following numbers 5-10 minutes prior to the call start: Finland: +358 981 710 310 Sweden: +46 85664 2651 UK: +44 333 300 08 04 US: +1 631 913 14 22 Confirmation code for the call is 80173894# An o

Telenor: The Covid-19 digitalisation wave makes its mark on 2021 tech trends22.1.2021 09:00:00 CETPress release

Telenor: The Covid-19 digitalisation wave makes its mark on 2021 tech trends (Fornebu, 22 January 2021) Digitalisation efforts in every corner of society will accelerate in the wake of Covid-19, predicts Telenor Research. From new technology to combat loneliness, to remote education that’s here to stay, compounded by password panic induced by rising security concerns - these are some of the trends that will shape 2021. The year 2020 will go down in history as not only one of the most challenging of the century, but also as one of the most transformative. Covid-19 has forced the global population to urgently adapt to a new way of life. A life lived much more digitally. “The pandemic has triggered us and nearly every industry around the globe to adapt at a rate once thought impossible. The past year has proved that digitalisation will be key to tackling major societal issues and to facilitate new ways of working and living in 2021,” says Bjørn Taale Sandberg, Head of Telenor Research. Fo

Participation Notification by Blackrock Inc.22.1.2021 08:30:00 CETPress release

Participation notification by Blackrock Inc. Brussels, 22 January 2021, 08:30 CET - According to Belgian transparency legislation (Law of May 2, 2007), BlackRock Inc. (55 East 52nd Street, New York, NY, 10055, U.S.A.) recently sent to Solvay the following transparency notifications indicating that it crossed the threshold of 3%. Here is a summary of the moves: Date on which the threshold was crossedVoting rights after the transactionEquivalent financial instruments after the transactionTotalJanuary 18, 20212.84%0.18%3.01%January 19, 20213.01%0.09%3.10% The latest notification, dated January 20, 2021, contains the following information: Reason for the notification: acquisition or disposal of voting securities or voting rightsNotified by: BlackRock Inc. (55 East 52nd Street, New York, NY, 10055, U.S.A.)Date on which the threshold is crossed: January 19, 2021Threshold of direct voting rights crossed: 3% upwardsDenominator: 105,876,416Additional information: The disclosure obligation arose

GrandVision reports comparable revenue growth of 0.8% in 4Q2022.1.2021 07:00:00 CETPress release

Schiphol, the Netherlands – 22 January 2021. GrandVision NV (EURONEXT: GVNV) publishes its preliminary and unaudited 4Q and FY20 revenue and comparable growth update. Fourth Quarter and Full Year Development Following a strong revenue recovery in the third quarter, GrandVision entered the fourth quarter with good momentum. The impact of the COVID-19 second wave subsequently built up through the quarter and slowed our progress resulting in 4Q revenue growth of 1.1% at constant exchange rates. Organic and comparable revenue growth for the quarter were 0.7% and 0.8% respectively. In the fourth quarter, we continued the strong EBITA momentum from the previous months. However, the increased restrictions in more and more countries due to the second wave in November and December resulted in a deceleration in the EBITA growth compared with the previous quarter. In the fourth quarter profit growth exceeded revenue growth. Revenue at constant exchange rates declined by 12.2% for the full year wi

Beter Bed Holding records strong sales growth of 28.7% in Q4 202022.1.2021 07:00:00 CETPress release

Highlights Q4 sales amount to € 61.3 million with strong growth driven across all businesses. Order intake in Benelux in Q4 (+15.1% like-for-like) and New Business (+52.0% like-for-like) resulted in +18.7% in order intake over Q4 and +24.8% for the full year (like-for-like).Order book rose to a record level of € 24.8 million (up 19% vs. 31 December 2019), despite the COVID-19 pandemic and store closures following the second lockdown as of mid-December.Online sales up 119.2% in Q4, leading to a channel share of 17.4% over Q4 and 14.8% for the full year. Strong performance New Business with significantly improved sales at Sängjätten and continued significant growth in the B2B channel at DBC. John Kruijssen, CEO of Beter Bed Holding, comments: “The fourth quarter of 2020 marks our seventh consecutive quarter of revenue growth for the Group both offline and online. Our strategy to improve sleep quality of our customers, through all activities we initiate, is clearly paying off. The investm

Jack Creek Investment Corp. Announces Pricing of $300 Million Upsized Initial Public Offering22.1.2021 03:51:48 CETPress release

NEW YORK, Jan. 21, 2021 (GLOBE NEWSWIRE) -- Jack Creek Investment Corp. (the “Company”), a special purpose acquisition company formed for the purpose of entering into a combination with one or more businesses, announced today the pricing of its upsized initial public offering of 30,000,000 units at a price of $10.00 per unit. The units will be listed on the Nasdaq Stock Market, LLC (“Nasdaq”) and will trade under the ticker symbol “JCICU” beginning on January 22, 2021. Each unit issued in the offering consists of one Class A ordinary share and one-half of one redeemable warrant. Each whole warrant entitles the holder thereof to purchase one Class A ordinary share at a price of $11.50 per share, subject to adjustment. After the securities comprising the units begin separate trading, the Class A ordinary shares and warrants are expected to be listed on Nasdaq under the symbols “JCIC” and “JCICW,” respectively. Jack Creek Investment Corp., led by Jeffrey Kelter, Robert Savage, Thomas Jerm

CrossAmerica Partners LP Maintains Quarterly Distribution21.1.2021 22:40:00 CETPress release

Allentown, Jan. 21, 2021 (GLOBE NEWSWIRE) -- CrossAmerica Partners LP Maintains Quarterly Distribution ·Quarterly distribution of $0.5250 per unit attributable to the fourth quarter of 2020 ALLENTOWN, PA (January 21, 2021) – CrossAmerica Partners LP (NYSE: CAPL) announced today that the Board of Directors of its general partner has approved a quarterly distribution of $0.5250 per unit attributable to the fourth quarter of 2020 (annualized $2.10 per unit). The distribution attributable to the fourth quarter is payable on February 9, 2021 to all unitholders of record on February 2, 2021. CrossAmerica will host a conference call on March 2nd at 9:00 a.m. Eastern Time to discuss year-end/fourth quarter earnings results, which will be released after the market closes on Monday, March 1. About CrossAmerica Partners LP CrossAmerica Partners is a leading wholesale distributor of motor fuels, convenience store operator, and owner and lessor of real estate used in the retail distribution of moto