Positive Phase 3 study with aprocitentan demonstrates significant antihypertensive efficacy in patients with resistant hypertension - Seite 2

Martine Clozel, MD and Chief Scientific Officer of Idorsia, commented:
“I have long been convinced that resistant hypertension is only resistant to treatment because the endothelin system had not been tackled. The observation of high endothelin levels in populations most at risk of developing resistant hypertension, as well as the close association between endothelin and the comorbidities often seen in patients with resistant hypertension, suggested that endothelin is a key contributor to the problem. I believe the top-line results from PRECISION support our initial hypothesis that endothelin is the missing link when hypertension is not adequately controlled with existing therapies.”

About aprocitentan
Aprocitentan is an investigational, novel, oral, dual endothelin receptor antagonist (ERA) which potently inhibits the binding of ET-1 to ET_A and ET_B receptors. Aprocitentan has a long half-life, a low potential for drug-drug interaction and a mechanism of action that is ideally suited for the pathophysiology of difficult-to-treat forms of hypertension.

About the PRECISION study¹² Danaietash P et al. J Clin Hypertension 2022 (in press) (NCT03541174)
Idorsia, in consultation with regulatory agencies, designed a single, international, multi-center, blinded randomized study with three sequential treatment parts. The study design addressed both the 4-week placebo-controlled efficacy of 12.5 and 25 mg aprocitentan (Part 1) and the durability of its effects in long-term active treatment with 25 mg aprocitentan for a further 32 weeks (Part 2) followed by a 12-week placebo-controlled withdrawal period with patients re-randomized to 25 mg or placebo (Part 3).

Patient population with established resistant hypertension
To confirm a diagnosis of resistant hypertension and exclude pseudo resistant hypertension, 1’965 patients entered a thorough 12-week screening period. During the screening period, qualifying patients were transitioned to guideline-recommended standardized background antihypertensive therapy of a fixed-dose combination of a calcium channel blocker (amlodipine), an angiotensin receptor blocker (valsartan) and a diuretic (hydrochlorothiazide) for at least 4 weeks before entering a 4-week single-blind run-in period. In this period, placebo was added to the background antihypertensive therapy. Patients with systolic blood pressure consistently above 140 mmHg were then randomized to the first treatment part.