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MarketScreener Homepage  >  Aktien  >  Swiss Exchange  >  Idorsia Ltd    IDIA   CH0363463438

IDORSIA LTD

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Idorsia : announces the first patient recruited into REACT - the Phase 3 registration study with clazosentan

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05.02.2019 | 07:02

Idorsia Pharmaceuticals Ltd. / Idorsia announces the first patient recruited into REACT - the Phase 3 registration study with clazosentan . Verarbeitet und übermittelt durch West Corporation. Für den Inhalt der Mitteilung ist der Emittent verantwortlich. Source: Globenewswire

  

  • REACT assesses the efficacy and safety of intravenous clazosentan for the prevention of clinical deterioration due to vasospasm-related delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH)
  • On June 18, 2018, Idorsia announced the plans for REACT and held an investor webcast, please refer to the documentation on our corporate website for more information

Allschwil, Switzerland - February 5, 2019
Idorsia Ltd (SIX: IDIA) today announced that the first patient has been included into REACT, a Phase 3 registration study to investigate the efficacy and safety of clazosentan for the prevention of clinical deterioration due to vasospasm-related delayed cerebral ischemia in patients following an aneurysmal subarachnoid hemorrhage.

Guy Braunstein, MD and Head of Global Clinical Development, commented:
"REACT builds on the learnings from previous clinical studies with clazosentan, which have served to identify the optimal treatment dose for Phase 3 evaluation and the characteristics and management of the patients that are most likely to benefit from this treatment. It is very satisfying to have achieved the milestone of first patient included into the study. It's now full steam ahead to recruit 400 patients."
  

  
Notes to the editor

About clazosentan
Several studies have built our understanding of clazosentan, an intravenous endothelin receptor antagonist, regarding its impact on preventing or reversing cerebral vasospasm. These studies suggest that clazosentan has the potential to prevent vasospasm-related delayed cerebral ischemia and to decrease the need for invasive neurovascular intervention. Clazosentan was granted orphan status in Europe in 2003 and in the US in 2006.

About the REACT study
REACT is a prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the efficacy and safety of clazosentan in preventing clinical deterioration due to vasospasm-related delayed cerebral ischemia, in adult patients with aSAH. Approximately 400 patients, regardless of whether their hemorrhage has been treated with surgical clipping or endovascular coiling are expected to be enrolled. Patients will be enrolled from 100 trial sites across 15 countries and will be randomized to either 15 mg/hr clazosentan or placebo for a treatment period of up to 14 days. The study is expected to run for over two years.

REACT will enroll aSAH patients identified as being at high-risk of developing delayed ischemic neurological deficit because of high volume of their hemorrhage, as assessed by CT scan on hospital admission. Patients experiencing asymptomatic (or minimally symptomatic) moderate to severe cerebral vasospasm within 14 days of the aneurysm-rupture may also be included.

About aneurysmal subarachnoid hemorrhage and cerebral vasospasm
Aneurysmal subarachnoid hemorrhage (aSAH) is a sudden life-threatening bleeding occurring in the subarachnoid space. It is caused by the rupture of an aneurysm - a weak, bulging spot on the wall of a cerebral artery. Emergency repair (endovascular coiling or microsurgical clipping) is required to stop the hemorrhage.

The bleeding and the release of a vasoconstrictor, endothelin, by the neighboring vascular endothelium, causes many patients to experience vasospasm (constriction of arteries in the brain). This diminishes blood flow to the brain and as a consequence, about one third of patients experience worsening of their neurological condition. Patients with thick and diffuse blood clots are at a significantly higher risk of experiencing cerebral vasospasm. Today, patients with vasospasm are typically treated with hemodynamic therapy, or more invasive neurovascular intervention such as balloon angioplasty or intra-arterial administration of vasodilators.

References

  • Macdonald R L, et al. Stroke. 2012; 43(6):1463-9.
  • Macdonald R L, et al. The Lancet. Neurology, 2011; 10(7):618-625.
  • Macdonald R L, et al. Stroke 2008; 39:3015-3021.
  • Vajkoczy P, et al. Journal of Neurosurgery 2005; 103:9-17.
  • Roux S. et al. J Pharmacol Exp Ther 1997; 283:1110-1118.

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 700 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.




This announcement is distributed by West Corporation on behalf of West Corporation clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Idorsia Pharmaceuticals Ltd. via Globenewswire

--- Ende der Mitteilung ---

Idorsia Pharmaceuticals Ltd.
Hegenheimermattweg 91 Allschwil Schweiz

ISIN: CH0363463438;


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Finanzkennziffern (CHF)
Umsatz 2019 30,1 Mio
EBIT 2019 -538 Mio
Nettoergebnis 2019 -543 Mio
Liquide Mittel 2019 254 Mio
Div. Rendite 2019 -
KGV 2019 -
KGV 2020
Marktkap. / Umsatz 2019 71,1x
Marktkap. / Umsatz 2020 35,2x
Marktkap. 2 392 Mio
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NameTitel
Jean-Paul Clozel Chief Executive Officer & Director
Jean-Pierre Garnier Chairman
André C. Muller Chief Financial Officer & Executive Vice President
Martine Clozel Chief Scientific Officer & Executive VP
Robert J. Bertolini Non-Executive Director
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