Roche Strikes Gold: $310 Million Investment in Alnylam Pays Off Big with Phase II Hypertension Victory

Alnylam’s Hypertension Breakthrough: Roche Partnership Pays Off in Phase II Triumph

In a stunning turn of events, Alnylam Pharmaceuticals is sprinting ahead with its game-changing RNAi therapeutic, zilebesiran, co-developed with Roche as part of their July 2023 deal. The Cambridge-based biotech just unveiled exhilarating Phase II results for this revolutionary gene-silencing therapy aimed at conquering hypertension.

In the pulse-pounding KARDIA-1 trial, zilebesiran not only met but exceeded expectations, hitting the primary endpoint by significantly reducing 24-hour mean systolic blood pressure (SBP) within just three months. The magic of zilebesiran slashed blood pressure by an astounding 15 mmHg more than the placebo at the highest tested doses. And that’s not all—key secondary endpoints were also decisively conquered, marking a resounding victory for Alnylam.

Now, here’s the plot twist: while most blood pressure drugs tackle excess water and blood vessel relaxation, zilebesiran operates on a completely different level. It’s a gene-silencing maestro that tames the infamous liver-expressed angiotensinogen (AGT), a key hypertension culprit. The RNAi therapeutic showed its mettle by maintaining the suppression of serum AGT levels for a remarkable six months.

Hold onto your seats, because the safety and tolerability profile of zilebesiran is nothing short of “encouraging,” according to Alnylam. With just one unfortunate incident of cardiopulmonary arrest, unrelated to the drug, the trial’s adult participants—ranging from untreated hypertension sufferers to those on stable medication regimens—sailed through.

But the suspense doesn’t end here. A riveting sequel, KARDIA-2, is already in progress, exploring zilebesiran’s potential in combination with standard antihypertensive agents. Brace yourselves for more excitement, as the next installment, featuring topline results, is slated for early 2024.

As the world grapples with cardiovascular disease, a silent global killer, hypertension remains its most formidable modifiable foe. “Up to 80% of individuals globally remain uncontrolled,” warns George L. Bakris, director of the American Heart Association Comprehensive Hypertension Center. Their vulnerability to cardiovascular, cerebrovascular, and renal diseases is a chilling reality.

Just a mere two months ago, Roche sealed a groundbreaking co-development and commercialization pact with Alnylam for zilebesiran. The deal, valued at $310 million upfront with a staggering potential of $2.8 billion in milestone payments, is nothing short of a blockbuster. In the event of approval, U.S. profits will be shared equally, while Roche reigns supreme outside the country.

Meanwhile, AstraZeneca’s own hypertension tale unfolds as they acquired CinCor Pharma, a cardiorenal disease biotech, in January 2023. Their Phase II thriller, starring baxdrostat, managed to reduce SBP in treatment-resistant hypertension patients by a whopping 11 mmHg more than the placebo. AstraZeneca, eyeing a blockbuster duo, aims to pair this treatment with its diabetes sensation, Farxiga, promising more twists and turns in the world of hypertension solutions.

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