Clinical data on Idorsia's pipeline compounds will be presented at the European Society of Cardiology Congress 2019
Allschwil, Switzerland – August 23, 2019
Idorsia Ltd (SIX: IDIA) today announced that data from Phase 2 studies with aprocitentan, a new dual endothelin receptor antagonist, and selatogrel, a highly-selective P2Y12 receptor antagonist, will be shared during the European Society of Cardiology (ESC) Congress 2019 in Paris, France.
An oral presentation entitled "Efficacy and safety of various doses of the new dual endothelin receptor antagonist aprocitentan in the treatment of hypertension", will be part of the "Drug treatment in hypertension - New insights" session with a focused discussion with the lead author, Dr Parisa Danaietash from Idorsia, at 09:54 on August 31, 2019. The abstract can be found online.
An oral presentation entitled "Selatogrel, a novel P2Y12 inhibitor for emergency use, achieves rapid, consistent and sustained platelet inhibition following single-dose subcutaneous administration in stable CAD patients", will be part of the "New developments in anti-thrombotic drug therapy" session with a focused discussion with the lead author, Professor Robert Storey, BM, Professor of Cardiology, University of Sheffield, UK, at 17:15 on September 1, 2019. The abstract can be found online.
A second oral presentation entitled "Inhibition of platelet aggregation after subcutaneous administration of a single-dose of selatogrel, a novel P2Y12 antagonist, in acute myocardial infarction: A randomised open-label phase 2 study", will be part of the "Emerging treatments in acute coronary syndromes" session with a focused discussion with the lead author, Professor Peter Sinnaeve, MD, Department of Cardiology, University Hospitals Leuven, Faculty of Medicine, University of Leuven, Belgium, at 11:34 on September 3, 2019. The abstract can be found online.
In addition, Idorsia representatives will be present at Stand B320 from 10:00 - 17:00 on Saturday, August 31, until Tuesday, September 3.
Notes to the editor
Aprocitentan is an orally active dual endothelin receptor antagonist, which is being investigated for patients whose hypertension is uncontrolled despite the use of three or more antihypertensive drugs.
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 fixed combination of a calcium channel blocker (amlodipine), an angiotensin receptor blocker (valsartan), and a diuretic (hydrochlorothiazide).
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 at Week 4, compared to placebo. Patients then enter a treatment period where they are treated with aprocitentan 25 mg for 32 weeks. This is followed by a double-blind, randomized 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 period.
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.
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 will oversee the Phase 3 development and submission for any additional indications.
Aprocitentan at ESC-19
Efficacy and safety of various doses of the new dual endothelin receptor antagonist aprocitentan in the treatment of hypertension.
Session: Drug treatment in hypertension – new insights, 34.
P Danaietash, P Verweij, B Flamion, J Menard, M Bellet; Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland, Clinical Investigation Centre, Inserm /Assistance Publique, Hôpitaux de Paris, Hôpital Européen and Université Paris-Descartes, Paris, France.
Saturday, August 31, 2019, 09:54 - 10:12
Selatogrel is a highly-selective P2Y12 receptor antagonist developed for acute coronary syndrome.
Two Phase 2 studies in patients with stable coronary artery disease and acute myocardial infarction, respectively, have met their pharmacodynamic objectives of significantly inhibiting platelet aggregation. Subcutaneous administration of selatogrel 8 mg and 16 mg has demonstrated a rapid onset of action, within 15 minutes, with the height of its effect extending over 4-8 hours, depending on the dose. The predefined extent of platelet aggregation inhibition was seen in at least 89% of the patients in both chronic and acute situations across doses. Selatogrel was safe and well tolerated in both studies and there were no treatment-emergent serious bleeds. Idorsia is now preparing for the end of Phase 2 meetings with health authorities where it will discuss a Phase 3 study.
Selatogrel at ESC-19
Selatogrel, a novel P2Y12 inhibitor for emergency use, achieves rapid, consistent and sustained platelet inhibition following single-dose subcutaneous administration in stable CAD patients.
Session: New Developments in Anti Thrombotic Drug Therapy, 2349.
Robert Storey, Paul Gurbel, Stefan James, Jurrien ten Berg, Jean-Francois Tanguay, Corine Bernaud, Jean-Marie Frenoux, Abdel Hmissi, Mike Ufer, Pim Van der Harst, Arnoud Van't Hof, George Dangas, Vijay Kunadian, Diana Gorog, Dietmar Trenk, Dominick Angiolillo.
Sunday, September 1, 2019, 17:15 - 17:32
Inhibition of platelet aggregation after subcutaneous administration of a single-dose of selatogrel, a novel P2Y12 antagonist, in acute myocardial infarction: A randomised open-label phase 2 study.
Session: Emerging Treatments in Acute Coronary Syndromes, 5232.
Peter Sinnaeve, Gregor Fahrni, Dan Schelfaut, Alessandro Spirito, Christian Mueller, Jean-Marie Frenoux, Abdel Hmissi, Corine Bernaud, Mike Ufer, Tizziano Mocetti, Shaul Atar, Marco Valgimigli.
Tuesday, September 3, 2019, 11:34 - 11:48
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 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.
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
Brunel stops activities in BIS - Earnings outlook substantially adjusted downwards22.10.2019 20:00:00 CEST | Press release
Amsterdam, 22 October 2019 BIS activities are loss-making and causing one-off costs Profitability further under pressure due to the performance in the Netherlands and expected tougher conditions in Germany After careful consideration, Brunel has decided to stop Brunel Industrial Services (BIS) in Texas, US. Since 2017, BIS has worked on various construction and maintenance projects, including large projects in shale oil & gas. As announced in Brunel´s Q2 results this August, we encountered issues with a project for a water treatment plant, which we won in 2018, leading to a one-off loss of EUR 5.5 million. We replaced the general manager and rebuild the organization, but at the same time we saw the market for shale oil & gas experiencing a slowdown with changing clients’ behavior in their contracting model from T&M to fixed pricing. As a consequence, our BIS-activities in Q3 were at a very low level, causing a disbalance with our organizational capacity and resulting in significant ope
Telenor Group and NENT Group to merge Canal Digital and Viasat Consumer22.10.2019 19:14:00 CEST | Press release
(Fornebu/Stockholm, 22 October 2019) Telenor Group and Nordic Entertainment Group (NENT Group) today announced the formation of a new company that combines Canal Digital and Viasat Consumer (satellite pay-TV & broadband-TV operations). This will create a vibrant Nordic TV distribution business and capture synergies in a maturing direct-to-home (DTH) segment. Telenor and NENT Group will each hold 50 percent of the new company. Highlights: The combination generates a Nordic player with combined net sales of approximately NOK 7 billion and around 1.25 million subscribers (Q2 2019). The combination is expected to yield peak annual cost synergies of approximately NOK 600 million, with full effect from 2022. Integration and other related costs are expected to total approximately NOK 830 million. The company will be headquartered in both Oslo and Stockholm, and will also have a substantial presence in Copenhagen. The joint venture will operate at arm’s length to its parents. The Nordic consum
Telenor og NENT slår sammen Canal Digital og Viasat Consumer22.10.2019 19:14:00 CEST | Pressemelding
(Fornebu / Stockholm, 22. oktober 2019) Telenor og Nordic Entertainment Group (NENT) kunngjør i dag opprettelsen av et nytt selskap som kombinerer Canal Digital og Viasat Consumer (satellitt- og bredbånds-TV). Dette vil skape en fremoverlent nordisk TV-distribusjonsvirksomhet og hente synergier i et modent direct-to-home segment (DTH). Telenor og NENT vil hver eie 50 prosent av det nye selskapet. Nøkkeltall Transaksjonen resulterer i et selskap med en total omsetning på ca 7 milliarder NOK og i overkant av 1,25 millioner kunder (Q2 2019). Transaksjonen er forventet å gi årlige synergier på inntil 600 millioner NOK med helårseffekt fra 2022. Det er forventet inntil 830 millioner NOK i integrasjonskostnader. Selskapet vil ha hovedkontorer i både Oslo og Stockholm, og vil også ha en betydelig tilstedeværelse i København. Selskapet vil operere på armlengdes avstand i forhold til eierne. Det nordiske kundetilbudet vil fokusere på satellittdistribuert betal-TV (DTH) og strømmetjenester, sam
Scanship Holding ASA : Presentation of 3Q 2019 Trading update, including contract awards on 22 October22.10.2019 16:59:00 CEST | Press release
Please find enclosed the presentation of the 3Q 2019 Trading update for Scanship Holding ASA, including the contract awards received the 22 October on the order backlog. For further queries, please contact: Henrik Badin - CEO Scanship Holding ASA Tel: +47 90 78 98 25 Email: email@example.com ABOUT SCANSHIP HOLDING ASA Scanship delivers world leading solutions for cleaner oceans in the Cruise and Aquaculture industries. Scanship provides advanced technologies for processing waste and purifying wastewater. Owners operating Scanship systems have the solution to convert all waste and wastewater into clean energy and purified water which meets the highest international discharge standards. Any residuals from the Scanship processes can be recovered for reuse. This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. Attachment 22102019_Scanship Holding ASA - 3Q2019 Trading Update with contract awards after presentation
European Commission has published a decision on the compatible state aid22.10.2019 16:58:00 CEST | Press release
European Commission has published a decision on the compatible state aid confirming that the measures proposed by the Republic of Lithuania to reduce the costs of maintenance of LNG terminal are compatible with the internal market and fulfil the criteria for state aid. The measures approved in this decision will create legal preconditions to reduce the costs of maintenance of LNG terminal by the amount of up to EUR 135,5 mln. until 2024. Further decisions will be approved by the Board and the General Meeting of Shareholders of AB Klaipedos nafta. More information on the approval of the European Commission is provided on the following: https://ec.europa.eu/competition/elojade/isef/case_details.cfm?proc_code=3_SA_53074 Jonas Lenkšas, Chief Financial Officer, +370 694 80594
Scanship Holding ASA : Scanship awarded clean ship system contracts and increases backlog to new record high22.10.2019 15:45:00 CEST | Press release
Scanship Holding ASA, through its subsidiary Scanship AS, has been awarded contracts with an European shipbuilder for the supply of a total Scanship clean ship system for two luxury and expedition class type of cruise ships. The newbuilds will enter service in 2022 and 2023. The contracts also include options for further deliveries to 6 newbuilds planned to enter service from 2024 and onwards. The luxury vessels will be delivered to one of the major US based shipowners. More details will be announced in relation to these contracts at a later stage. The Scanship contracts includes delivery of systems for food waste processing, garbage handling and wastewater purification, to meet the industry's highest environmental regulations worldwide and particularly the new regulations now being enforced in the Baltic Sea. This latest order intake accumulates the total order backlog to a record high level of NOK 710 million firm and NOK 570 million of optional contracts. For further queries, please