GlobeNewswire

Clinical data on Idorsia's pipeline compounds will be presented at the European Society of Cardiology Congress 2019

Share

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.

Idorsia’s aprocitentan
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.

Idorsia’s selatogrel
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

About aprocitentan
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
Oral presentation:
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

About selatogrel
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
Oral presentation:
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

Oral presentation:
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

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 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
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.

Attachment

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

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

LIDDS Liproca® Depot Phase IIb study results presented at EMUC19 showing both primary and secondary endpoints being met16.11.2019 10:10:00 CETPress release

UPPSALA, SWEDEN – LIDDS AB (publ) Phase IIb clinical data from the LPC-004 prostate cancer study on LIDDS Liproca® Depot were presented today in an oral session at the 11th European Multidisciplinary Congress on Urological Cancers, EMUC19. The study met both its primary and secondary endpoints as well as demonstrated that a larger proportion of intermediate risk patients, which is the Liproca Depot target group, are PSA responders. The presentation can be accessed through LIDDS webpage and are also attached to this release. The phase IIb results from the LPC-004 prostate cancer study was presented as “Late Breaking News” at EMUC in Vienna on November 16, 2019 by Professor Laurence Klotz, a world leading expert in Active Surveillance of prostate cancer patients. Professor Klotz was one of the LPC-004 study investigators and is Professor at the University of Toronto Division of Urology at the Sunnybrook Health Sciences Centre in Canada. The preliminary data recently released from the pha

AMG Advanced Metallurgical Group N.V. Completes Acquisition of International Specialty Alloys15.11.2019 23:30:00 CETPress release

Amsterdam, 15 November 2019 --- AMG Advanced Metallurgical Group N.V. ("AMG", EURONEXT AMSTERDAM: "AMG") has finalized the acquisition of the assets of International Specialty Alloys ("ISA"), a leading U.S. producer of titanium master alloys and other binary alloys for the aerospace market, from Kennametal, Inc. The acquisition was previously announced on October 9, 2019 and closed and became effective today. About AMG AMG is a global critical materials company at the forefront of CO2 reduction trends. AMG produces highly engineered specialty metals and mineral products and provides related vacuum furnace systems and services to the transportation, infrastructure, energy, and specialty metals & chemicals end markets. AMG Critical Materials produces aluminum master alloys and powders, ferrovanadium, natural graphite, chromium metal, antimony, lithium, tantalum, niobium and silicon metal. AMG Technologies produces titanium aluminides and titanium alloys for the aerospace market; designs,

New Novartis medicine Adakveo® (crizanlizumab) approved by FDA to reduce frequency of pain crises in individuals living with sickle cell disease15.11.2019 21:06:00 CETPress release

Sickle cell pain crises are unpredictable, severe events associated with life-threatening complications1 Adakveo reduced the annual rate of sickle cell pain crises by 45% compared to placebo (1.63 vs 2.98) and the annual rate of days hospitalized (4 vs 6.87) in a 52-week study2 Approximately 100,000 people in the United States, most of whom are of African descent, have sickle cell disease3 Approval comes approximately two months ahead of FDA’s priority review action date, allowing Adakveo to be available to patients more quickly Basel, November 15, 2019 – Novartis announced today that the US Food and Drug Administration (FDA) approved Adakveo ® (crizanlizumab), previously known as SEG101, to reduce the frequency of vaso-occlusive crises (VOCs), or pain crises, in adult and pediatric patients aged 16 years and older with sickle cell disease.4 Adakveo represents the first FDA-approved medicine in sickle cell disease that binds to P-selectin –a cell adhesion protein that plays a central r

SFL - Invitation to Presentation of Q3 2019 Results15.11.2019 20:06:00 CETPress release

SFL Corporation Ltd. ("SFL" or the “Company”) (NYSE: SFL) plans to release its preliminary financial results for the third quarter of 2019 on Thursday, November 21, 2019. SFL plans to host a conference call and webcast for all stakeholders and interested parties on Thursday, November 21, 2019 at 10:00 AM (EST) / 4:00 PM (CET). Relevant material will be available from the Investor Relations section of the Company’s website at www.sflcorp.com on the same day. In order to listen to the presentation you may do one of the following: A: Webcast Visit the Investor Relations section of the Company’s website at www.sflcorp.com and click on the link to "Webcast". The webcast with slideshow will be played live from this platform. To listen to the conference call from the website, you need to have installed Windows Media Player, and you need to have a sound card on your computer. B: Conference Call Participants dial-in details: US Toll Free telephone number +1 866 966 1396 International Dial-in te

Cavotec’s Nomination Committee ahead of Annual General Meeting 202015.11.2019 18:00:00 CETPress release

The Nomination Committee of Cavotec SA (“Cavotec”) consists of members appointed by Cavotec’s Board of Directors, in accordance with Cavotec's Internal Regulations. The composition of the members of the Nomination Committee presented below is in line with the recommendations of the Swedish Corporate Governance Code. The main purpose and responsibility of the Nomination Committee is to present proposals for the election and remuneration of the Chairman and the Board of Directors as well as the Auditors to the Annual General Meeting 2020. The Board of Directors has decided that the four largest shareholders and the Chairman of Cavotec’s Board of Directors shall be represented in the Nomination Committee. On 31 October 2019, the four largest shareholders recorded in the company’s share register were Bure Equity AB (27.1% of the vote), AP4 (9.8% of the vote), Nomina SA (8.1% of the vote) and Founding Shareholders (Stefan Widegren, Lars Hellman and Peter Brandel with families) (11.9 % of th

Touax: Nine-Month Revenue From Activities: +4.9%15.11.2019 17:45:00 CETPress release

PRESS RELEASE Paris, 15 November 2019 – 5.45 p.m. YOUR OPERATIONAL LEASING SOLUTION NINE-MONTH REVENUE FROM ACTIVITIES: +4.9% Revenue 1 up 1.4% in the third quarter of 2019, Revenue up 4.9% over the first nine months of the year (+1.5% at constant scope and currency) validating the group’s strategic objectives ANALYSIS OF REVENUE FROM ACTIVITIES Q3 2019 revenue totalled €40.1 million vs. €39.6 million in Q3 2018, an increase of 1.4%. Over the first nine months of the year, revenue from activities totalled €119.6 million (€115.7 million at constant scope and currency), up 4.9% compared to the same period in 2018. Revenue from leasing activities amounted to 99.8 million euros (96.8 million euros at constant scope and currency) at 30 September 2019, including a 10% increase in the Leasing Revenue on owned equipment (36.9 million euros). Leasing Revenue from leasing activities stood at 99.9 million euros in the first nine months of 2018. Sales rose to €19 million (€14.2 million at constant