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Monday, June 28, 2021

Idorsia initiates Phase 3 registration study with selatogrel for acute myocardial infarction

 to host an investor webcast to discuss the Phase 3 study today at

      14:30hrs CEST 

Idorsia Ltd (SIX: IDIA) today announced the initiation of the Phase 3 registration study "SOS-AMI" to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia's P2Y(12) receptor antagonist, in suspected acute myocardial infarction (AMI).

An AMI, or heart attack, is a life-threatening condition that occurs when blood flow to the heart muscle (myocardium) is suddenly decreased or completely cut off by a blood clot in one or more of the coronary vessels. An AMI requires immediate treatment, as any delay in intervention can result in irreversible damage to the heart muscle and adverse clinical outcomes. According to the US Centers for Disease Control and Prevention, each year more than 800,000 persons living in the US will suffer a heart attack.([1])

Although the management of AMI has improved in recent decades, morbidity and mortality associated with AMI remain high. The majority of deaths occur outside the hospital.([) (2,3) (]) Early action is crucial for survival and to preserve heart muscle.

Besides aspirin, there are no treatment options currently available for the critical time from onset of AMI symptoms to first medical contact. The development of selatogrel in an autoinjector aims to fulfill this medical gap: upon symptoms suggestive of a heart attack, patients would self-inject selatogrel as early as possible and immediately call for emergency medical help.

To be effective, any antithrombotic treatment for use at the onset of AMI symptoms should be rapidly absorbed and potent, acting quickly to inhibit thrombus formation at an early stage. Inhibition should be reversed after a few hours to avoid interfering with later patient management decisions. It must also have an appropriate safety profile for use prior to formal diagnosis of AMI. Selatogrel has the potential to satisfy these necessary conditions.

Selatogrel administered subcutaneously is a potent, highly selective, fast-acting, reversible P2Y(12) receptor antagonist. Two published Phase 2 studies, one in patients with chronic coronary syndromes and one in patients with AMI showed fast and reversible inhibition of platelet aggregation. Subcutaneous administration of selatogrel 16 mg has demonstrated a rapid onset of action, within 15 minutes, with the magnitude of the effect extending over approximately eight hours. Selatogrel was safe and well tolerated in both studies.([) (6,7) (])


Investor webcast

An investor conference call and webcast will be held to discuss the Phase 3 program. The call will start with presentations by senior management, followed by a Q&A session (live access to the speakers).

Date: Monday June 28, 2021

Time: 14:30 CEST | 13:30 BST | 08:30 EDT

Webcast participants should visit Idorsia's website www.idorsia.com 10-15 minutes before the webcast is due to start.

Conference call participants should start calling the number below 10-15 minutes before the conference is due to start.

Dial-in: CH: +41 44 580 6522 | UK: +44 20 3009 2470 | US: +1 877 423 0830

PIN: 27481532#

https://www.marketscreener.com/quote/stock/IDORSIA-LTD-35837944/news/Press-Release-nbsp-Idorsia-initiates-the-Phase-3-registration-study-with-selatogrel-for-the-treatm-35727043/

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