Phase 2 trial of novel injectable antihypertensive drug meets primary endpoint
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Key takeaways:
- Zilebesiran, an injectable RNA interference agent, met the primary endpoint in the phase 2 KARDIA-2 trial of patients with hypertension.
- Full results will be presented in April.
Alnylam announced that the KARDIA-2 phase 2 trial of its novel injectable antihypertensive drug zilebesiran met its primary endpoint.
Full results of KARDIA-2 will be presented at the American College of Cardiology Scientific Session in April, according to a press release from the company.
As Healio previously reported, in the phase 2 KARDIA-1 trial, a single dose of zilebesiran, an investigational RNA interference therapeutic targeting liver-expressed angiotensinogen, lowered systolic BP at 3 months and sustained the reduction to 6 months in patients with daytime mean ambulatory systolic BP of 135 mm Hg to 160 mm Hg.
The company stated in the release that in KARDIA-2, which enrolled 672 adults with mild to moderate hypertension, zilebesiran achieved “clinically and statistically significant additive, placebo-adjusted reductions in [the primary endpoint of] 24-hour mean systolic BP at month 3 as measured by ambulatory BP monitoring.” The reduction was achieved in each of three cohorts, one also taking a thiazide-type diuretic, one also taking a calcium channel blocker and one also taking an angiotensin receptor blocker.
Zilebesiran also “demonstrated an encouraging safety and tolerability profile,” according to the release.
“We are thrilled that a single dose of zilebesiran achieved clinically significant, additional reductions in systolic blood pressure when administered to patients who are not adequately controlled with commonly prescribed antihypertensives,” Simon Fox, PhD, vice president and program lead for zilebesiran at Alnylam, said in the release. “These KARDIA-2 results, showing durable additional levels of blood pressure reduction on top of what is achieved by standard of care first-line antihypertensives with an encouraging safety profile, reinforce our confidence in zilebesiran’s differentiated profile. We look forward to sharing the full KARDIA-2 data as a late-breaking clinical trial at the upcoming American College of Cardiology Annual Scientific Session.”
Alnylam and Roche also announced that the phase 2 KARDIA-3 trial has been launched, which will evaluate zilebesiran as an add-on therapy for adult patients with high CV risk and uncontrolled hypertension despite treatment with two to four standard of care antihypertensive medications, according to the release.
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