Alnylam Presents Positive Late-Breaking Data from Ongoing Phase 1 Study of ALN-AGT, an Investigational RNAi Therapeutic for the Treatment of Hypertension - Seite 2
Suboptimal BP control remains the most common attributable risk factor for cardiovascular disease and cerebrovascular disease, and a leading cause of chronic kidney disease progression. These durable pharmacologic effects of ALN-AGT may support tonic control of BP with once quarterly and potentially biannual dosing. Less frequent dosing than available with current treatment options may help achieve improved medication adherence, an important part of maintaining BP control.ii
ALN-AGT was shown to be generally well tolerated with an acceptable safety profile that supports advancement into Phase 2 studies. Most adverse events (AEs) were mild or moderate in severity and resolved without intervention, with the most common AE consisting of mild and transient injection site reactions in 5 out of 56 patients (8.9 percent) receiving ALN-AGT. There were no clinically significant elevations in serum alanine aminotransferase (ALT), serum creatinine or serum potassium, and no patient required intervention for hypotension. There were no treatment-related serious AEs, deaths or AEs leading to study withdrawal.
“We believe the results for ALN-AGT are highly encouraging and demonstrate the potential of an RNAi therapeutic to help people reach and maintain their blood pressure goals,” said Akshay Vaishnaw, M.D., Ph.D., President of R&D at Alnylam. “We believe ALN-AGT has the potential to transform the way hypertension is managed, a disease that has been devoid of new therapeutic interventions for decades and remains a major contributing risk factor for stroke, heart attack and sudden death. Based on these findings, we look forward to advancing the clinical program for ALN-AGT with the initiation of Phase 2 KARDIA studies planned in mid-2021.”
To view the data presented at the ESH-ISH 2021 Joint Meeting, please visit www.alnylam.com/capella.
About ALN-AGT Phase 1 Study
The Phase 1 study is a multi-center, randomized, double-blind, placebo-controlled, single dose (SD) and active comparator-controlled multiple dose (MD) trial designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of ALN-AGT in patients with essential hypertension. The study is being conducted in four parts: single ascending dose (SAD) phase in hypertensive patients; SD phase in hypertensive patients with controlled salt intake; MD phase in hypertensive patients who are obese, with once daily oral doses of irbesartan (angiotensin II receptor blocker) used as the active comparator; and open-label SD phase with co-administration of irbesartan in hypertensive patients. Patients will be randomized 2:1 ALN-AGT to placebo or ALN-AGT to irbesartan. The planned enrollment for this study, including optional cohorts, is up to 160 patients.