USA — Alnylam Pharmaceuticals, in collaboration with Roche, is advancing rapidly with its groundbreaking RNAi therapeutic, zilebesiran, following their July 2023 partnership.

Exciting news emerged as the Cambridge-based biotech unveiled positive Phase II results for their gene-silencing therapy designed to combat hypertension.

In the KARDIA-1 trial, zilebesiran, developed by Alnylam, achieved its primary objective by significantly reducing the 24-hour mean systolic blood pressure (SBP) in patients with high cardiovascular risk and hypertension within just three months.

The remarkable therapy demonstrated the ability to lower blood pressure by over 15 mmHg compared to a placebo at the two highest tested doses. Additionally, Alnylam reported successful outcomes for key secondary endpoints in the trial.

Zilebesiran, unlike most blood pressure medications that eliminate excess body water to relax blood vessels, employs gene-silencing technology.

It targets liver-expressed angiotensinogen (AGT), a pivotal player in hypertension’s development. Impressively, the RNAi therapeutic maintained a durable reduction in serum AGT levels throughout the first six months of treatment.

Alnylam noted that the therapy exhibited a reassuring safety and tolerability profile during the study, with one reported death due to cardiopulmonary arrest considered unrelated to the drug.

The study enrolled adults with untreated hypertension or those on stable therapy with one or more medications.

A second Phase II study, KARDIA-2, is currently underway, assessing zilebesiran in combination with one of three standard antihypertensive agents. Anticipated topline results are expected in early 2024.

Despite various classes of oral antihypertensive treatments being available, cardiovascular disease remains the leading global cause of death, with hypertension as the most common modifiable risk factor for premature cardiovascular mortality.

George L. Bakris, director of the American Heart Association Comprehensive Hypertension Center, highlighted the critical need for effective hypertension treatments.

He stated, “Despite the availability of several classes of oral anti-hypertensive treatments, up to 80% of individuals globally remain uncontrolled, leaving them at an increased risk of cardiovascular, cerebrovascular, and renal disease.”

Roche and Alnylam entered into a co-development and commercialization agreement for zilebesiran less than two months ago.

In this deal, Alnylam received an initial US$310 million in cash, with the potential for up to US$2.8 billion in milestone payments.

If approved, both companies will equally share U.S. profits, while Roche will hold rights to market the drug outside the United States.

In January 2023, AstraZeneca acquired CinCor Pharma, a biotech specializing in cardiorenal diseases, for its investigational hypertension treatment.

A Phase II study of baxdrostat revealed a promising reduction of 11 mmHg in SBP for patients with treatment-resistant hypertension compared to a placebo.

AstraZeneca is exploring the possibility of combining this treatment with its blockbuster diabetes drug, Farxiga. This signifies a growing interest in innovative solutions to address the widespread issue of hypertension.

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