Roche/Alnylam Blood Pressure Drug Aces In Mid-Stage Trial, Analyst Says Zilebesiran As Promising Opportunity In Addressing Global Hypertension Challenges

Zinger Key Points
  • Roche, Alnylam's Zilebesiran demonstrated encouraging safety and tolerability profile when added to standard-of-care antihypertensives.
  • Alnylam/Roche started KARDIA-3 Phase 2 study of zilebesiran as an add-on therapy for high cardiovascular risk and uncontrolled hypertension.

Tuesday, Alnylam Pharmaceuticals Inc ALNY said the KARDIA-2 Phase 2 study of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) for hypertension, met the primary endpoint.

The data showed that zilebesiran resulted in clinically and statistically significant additive, placebo-adjusted reductions in 24-hour mean systolic blood pressure (SBP) at Month 3 in each of three independent patient cohorts receiving the standardized background therapies of either a thiazide-like diuretic (indapamide), calcium channel blocker (amlodipine) or angiotensin receptor blocker (olmesartan). 

Zilebesiran demonstrated an encouraging safety and tolerability profile when added to these standard-of-care antihypertensives. 

Zilebesiran is being co-developed and co-commercialized by Alnylam and Roche Holdings AG RHHBY.

Alnylam and Roche also initiated a global KARDIA-3 Phase 2 study to evaluate the efficacy and safety of zilebesiran used as an add-on therapy in adult patients with high cardiovascular risk and uncontrolled hypertension despite treatment with two to four standard of care antihypertensive medications. 

William Blair expressed optimism about a recent data release, which lacked specific details but hinted at a positive midstage study. The anticipation is high for more data at the upcoming ACC event. 

Zilebesiran is seen as a promising opportunity, especially considering that one in three adults globally has hypertension, and a significant percentage remains uncontrolled despite available treatments. 

However, investor attention is currently focused on the HELIOS-B trial, evaluating vutrisiran in ATTR-CM, with results expected in June or July after adjustments to analysis plans. 

HELIOS-B is a pivotal event for Alnylam, contributing a substantial portion of its value. 

The analyst maintains a positive outlook on TTR silencers as a potential treatment for TTR-CM, citing promising results from previous studies (APOLLO-B and HELIOS-A), and reiterates an Outperform rating on Alnylam.

Price Action: ALNY shares are down 1.22% at $148.21 on the last check Tuesday.

Photo: Darko Stojanovic from Pixabay

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