Core Insights - The Phase 3 PRECISION trial analysis demonstrates the renal-protective benefits of aprocitentan alongside significant blood pressure reduction in high-risk chronic kidney disease (CKD) patients with resistant hypertension [1][2][3] Company Overview - Idorsia Ltd, headquartered in Allschwil, Switzerland, focuses on developing transformative medicines, including aprocitentan, which targets the endothelin pathway for treating systemic hypertension and resistant hypertension [2][10][22] Clinical Study Findings - The PRECISION study involved 730 patients with confirmed resistant hypertension, with a specific focus on 147 participants with CKD categorized as high or very high risk according to KDIGO criteria [9][11] - Aprocitentan significantly reduced office systolic blood pressure (SBP) by -15.3 mmHg and -15.2 mmHg for the 12.5 mg and 25 mg doses, respectively, compared to -11.5 mmHg for placebo [13] - Nighttime ambulatory SBP was reduced by -9.6 mmHg and -13.8 mmHg for the 12.5 mg and 25 mg doses, respectively, versus -2.5 mmHg with placebo [14] - Aprocitentan also lowered urinary albumin-to-creatinine ratio (UACR) by -47.1% and -59.6% for the respective doses, indicating a significant antiproteinuric effect [14] Safety and Tolerability - Aprocitentan was well tolerated, with the most common adverse event being mild-to-moderate peripheral edema, manageable with diuretic adjustments [3][16] - No significant changes in potassium levels or estimated glomerular filtration rate (eGFR) were observed, indicating a favorable safety profile [14][16] Market Context - Approximately 1.4 billion people globally suffer from hypertension, which remains a leading health challenge and a major risk factor for cardiovascular diseases [5][6] - In the US, around 50% of patients with hypertension on multiple treatments do not achieve blood pressure control, highlighting the need for effective therapies like aprocitentan [5][6]

Core Insights - Idorsia Ltd announced the publication of a new analysis from the Phase 3 PRECISION study, highlighting the effects of aprocitentan on blood pressure variables in resistant hypertension [1][6] Company Overview - Aprocitentan (TRYVIO™/JERAYGO™) is the first approved antihypertensive targeting the endothelin pathway, showing significant reductions in 24-hour blood pressure, especially at night [2][7] - Aprocitentan is approved in the US and EU for treating resistant hypertension in combination with other antihypertensives, with commercial availability since October 2024 [7][24] Clinical Findings - The PRECISION study demonstrated that aprocitentan led to substantial improvements in ambulatory blood pressure parameters predictive of cardiovascular risk, potentially reducing cardiovascular events [3][10] - Aprocitentan treatment normalized dipping patterns in non-dippers and reduced blood pressure load by approximately 20% during both daytime and nighttime [11][13] - The drug's efficacy was consistent across patients with varying arterial stiffness and salt sensitivity, indicating its broad applicability in difficult-to-control hypertension [11][12] Market Context - Approximately 1.4 billion people globally suffer from hypertension, with many patients remaining uncontrolled despite multiple treatments [5][9] - In the US, around 50% of patients with hypertension on multiple therapies do not achieve blood pressure control, highlighting a significant medical need [5][9] Research and Development - The PRECISION study was a multicenter, randomized, double-blind trial involving 730 patients, assessing the efficacy of aprocitentan against placebo [8][10] - The study's primary endpoints included changes in office systolic blood pressure, with significant reductions observed in both the 12.5 mg and 25 mg doses of aprocitentan compared to placebo [10][12] Safety Profile - Treatment-emergent adverse events were reported in 27.6% and 36.7% of patients treated with aprocitentan 12.5 mg and 25 mg, respectively, with fluid retention being the most common side effect [14]

Core Insights - Idorsia Ltd announced the publication of a new analysis from the Phase 3 PRECISION study, highlighting the effects of aprocitentan on blood pressure variables in resistant hypertension patients [1][7]. Group 1: Aprocitentan's Efficacy - Aprocitentan significantly lowered 24-hour blood pressure in patients with resistant hypertension, especially at night, which is a critical indicator of long-term outcomes [2][12]. - The analysis showed that aprocitentan improved multiple characteristics linked to poor clinical outcomes, including blood pressure load reduction and normalization of night-time dipping patterns [2][12]. - Aprocitentan was effective in patients with increased arterial stiffness and salt sensitivity, indicating its broad applicability [2][12]. Group 2: Clinical Implications - Experts believe that aprocitentan could reduce cardiovascular events and improve long-term outcomes for patients with resistant hypertension [3][4]. - The drug addresses a significant medical need for patients with difficult-to-control hypertension, without the risks associated with hyperkalemia or worsening renal function [5][4]. - Aprocitentan is now included in the American College of Cardiology and American Heart Association guidelines for managing high blood pressure [8]. Group 3: Study Design and Findings - The PRECISION study was a multicenter, randomized, double-blind trial involving 730 patients, assessing the efficacy of aprocitentan against placebo [9][10]. - Key findings included a significant reduction in office systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 4 weeks, with differences of -15.3 mmHg and -15.2 mmHg for aprocitentan doses compared to placebo [11]. - Aprocitentan treatment led to a higher proportion of patients normalizing their nocturnal blood pressure fall, a positive prognostic indicator [12][14]. Group 4: Safety Profile - Treatment-emergent adverse events were reported in 27.6% and 36.7% of patients treated with aprocitentan, with fluid retention being the most common side effect [15]. - Fluid retention was generally mild to moderate and manageable with current clinical practices [15]. Group 5: Market Context - Approximately 1.4 billion people globally live with hypertension, making it a leading health challenge [5]. - In the US, about 50% of patients with hypertension on multiple treatments do not achieve blood pressure control, highlighting the need for effective therapies like aprocitentan [5].