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Roche and Alnylam are set to begin a Phase 3 study for a hypertension drug. The study aims to assess the cardiovascular outcomes of the drug, which is currently in development. Roche is a research-based healthcare company with divisions in Pharmaceuticals and Diagnostics, while Alnylam is a biotech company focused on RNAi therapeutics.

Roche (OTCQX: RHHBY) and Alnylam (Nasdaq: ALNY) have announced plans to advance zilebesiran into a Phase III cardiovascular outcomes trial (CVOT) for uncontrolled hypertension treatment. The decision follows comprehensive Phase II KARDIA program results, particularly KARDIA-3, which demonstrated clinically meaningful blood pressure reductions [1].

Zilebesiran, an investigational RNAi therapeutic, is being developed to reduce cardiovascular risk in high unmet need populations. The upcoming ZENITH Phase III trial will enroll approximately 11,000 patients, evaluating zilebesiran's effectiveness in reducing cardiovascular events in high-risk patients on multiple antihypertensives [1].

The KARDIA-3 study, part of the KARDIA program, showed that zilebesiran (300mg) achieved placebo-adjusted systolic blood pressure reductions of -5.0 mmHg at month three and -3.9 mmHg at month six. Notably, patients on diuretics with baseline BP 140 mmHg showed stronger results of -9.2 mmHg and -8.3 mmHg at three and six months, respectively [1].

The ZENITH Phase III trial will be a CVOT enrolling approximately 11,000 patients and evaluating zilebesiran (300 mg) every six months compared to placebo in patients with uncontrolled hypertension with either established CV disease or at high risk for CV disease on two or more antihypertensives, one being a diuretic [1].

Hypertension is the primary cause of and number one modifiable risk factor for cardiovascular disease. An estimated one in three adults, over 1.2 billion people worldwide, have hypertension and despite the wide availability of antihypertensives, up to 80% of them do not achieve adequate blood pressure control [1].

The ZENITH trial is expected to be initiated by the end of 2025 and will be submitted to global regulators. Roche and Alnylam are co-developing and co-commercializing zilebesiran [1].

References:
[1] https://www.stocktitan.net/news/RHHBY/roche-and-alnylam-advance-zilebesiran-into-global-phase-iii-a64odjes3xk0.html