Positive Phase 3 study with aprocitentan demonstrates significant antihypertensive efficacy in patients with resistant hypertension

Ad hoc announcement pursuant to Art. 53 LR

• Aprocitentan reduces blood pressure compared to placebo by week 4 of treatment, the effect is maintained and confirmed over a period of 48 weeks, and is generally well tolerated with no major safety concerns
• Primary and key secondary endpoints were met with statistical significance and clinically meaningful results – the effect was consistent across multiple endpoints and methodologies of blood pressure monitoring
• Idorsia to host an investor webcast to discuss PRECISION top-line results tomorrow May 24 at 14:00hrs CEST

Allschwil, Switzerland – May 23, 2022
Idorsia Ltd (SIX: IDIA) today announced positive top-line results of PRECISION, the Phase 3 study investigating aprocitentan, Idorsia’s dual endothelin receptor antagonist, for the treatment of patients whose blood pressure is not adequately controlled despite receiving at least triple antihypertensive therapy – known as resistant hypertension. Aprocitentan significantly reduced blood pressure when added to standardized combination background antihypertensive therapy in patients with resistant hypertension over 48 weeks of treatment.

Hypertension is one of the most common cardiovascular risk factors, and its prevalence continues to rise. According to a recent study, there are more than one billion people living with hypertension worldwide – a number which has almost doubled in the past 40 years.¹

While many patients with hypertension are successfully treated with various existing anti-hypertensive therapies, 10–20% of the hypertensive population have blood pressure that remains high despite receiving at least three antihypertensive medications of different pharmacological classes, including a diuretic, at optimal doses, and they are categorized in hypertension guidelines^2,3,4 and in the medical community as having resistant hypertension. Certain populations are at a particular high risk of developing resistant hypertension later in life; these include patients with a high body mass index (BMI), African Americans, post-menopausal women and patients with obstructive sleep apnea.^5,6,7

It is estimated that by 2025, there could be approximately 10 million patients in the US who could be classified as having resistant hypertension and a similar number of patients in Europe.^3,4,8 Uncontrolled hypertension can lead to multiple cardiovascular and renal adverse outcomes, including stroke, heart disease, and kidney failure. These co-morbidities increase a patient's vulnerability and the complexity of their treatment.^9,10,11