Ad hoc announcement pursuant to Art. 53 LR
- Idorsia to host an investor webcast to discuss the Phase 3 study today at 14:30hrs CEST
Allschwil, Switzerland – June 28, 2021
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 P2Y12 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.
Martine Clozel, MD and Chief Scientific Officer at Idorsia, commented:
"From the moment that symptoms start, the clock is ticking. Thrombus formation is progressing, and ischemia is rapidly causing irreversible damage to the heart. In the initial stages of thrombus formation, platelet aggregation dominates – a process in which the platelet P2Y12 receptor plays a key role. If left untreated, the thrombus will become fibrin rich, at which point platelets have a more limited role in thrombus formation. This suggests that a fast-acting P2Y12 receptor antagonist could cut short the thrombus formation in the initial stages of thrombus formation. Our drug discovery team has created a compound with unique properties which might fill this important therapeutic gap."
Dr Deepak L. Bhatt, MD, MPH, Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital, Professor of Medicine at Harvard Medical School, and Chair of the Steering Committee for SOS-AMI, commented:
"P2Y12 receptor antagonists have been used in the treatment of millions of patients globally, and their safety and efficacy profiles are well established. Despite the success of chronic treatment with this class and other effective interventions, patients are still suffering recurrent heart attacks. The idea for patients to self-inject early in the onset of symptoms is truly innovative. The subcutaneous route of administration could overcome the onset delay observed with oral compounds from the same class."
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.
A Special Protocol Assessment has been agreed with the FDA. This indicates the FDA is in agreement with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints and planned analyses) for a study intended to support a future marketing application.
In December 2020, the FDA designated the investigation of selatogrel for the treatment of a suspected AMI in adult patients with a history of AMI as a "fast-track" development program. This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need.
Notes to the editor
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#
The need for an early intervention has been highlighted by the guidelines of the European Society of Cardiology, which identified the prehospital phase as the most critical for high-risk patients and reiterated that efforts must be made to reduce the delay in initiation of treatment in order to reduce death.[4,5]
About Dr Deepak L. Bhatt
Deepak L. Bhatt MD, MPH, FACC, FAHA, FSCAI, FESC, is Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School.
Key literature
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 a leading biopharmaceutical company, with a strong scientific core.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 900 highly qualified specialists dedicated to realizing our ambitious targets.
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