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Chugai Secures License for RNAi Therapy Zilebesiran Targeting Hypertension in High Cardiovascular Risk Population

NextEdge Admin

18 Apr 2024

3 min 3 sec

Chugai Pharmaceutical Co., Ltd recently finalized a licensing agreement with Roche for zilebesiran, an innovative RNAi therapeutic designed for hypertension. Developed by Alnylam Pharmaceuticals, Inc. and currently undergoing development by Roche and Alnylam, zilebesiran targets angiotensinogen (AGT) to reduce vasoconstrictor angiotensin II levels by hindering its synthesis in the liver.

The agreement grants Chugai commercialization rights in Japan for zilebesiran, with Roche set to receive upfront fees and milestone payments. Recognizing hypertension’s severity and its link to various cerebrovascular and cardiovascular events, Chugai’s President and CEO, Dr. Osamu Okuda, emphasized the critical unmet need in managing hypertension, where up to 80% of patients still exhibit uncontrolled blood pressure.

Zilebesiran’s efficacy and safety were demonstrated in the global Phase II KARDIA-2 study, where it significantly reduced systolic blood pressure (SBP) when added to standard antihypertensive therapies. The ongoing KARDIA-3 study aims to further evaluate zilebesiran’s efficacy in patients with high cardiovascular risk and uncontrolled hypertension.

Hypertension stands as a leading cause of cardiovascular disease globally, emphasizing the urgency for innovative treatments. Zilebesiran, with its RNAi mechanism targeting AGT, holds promise for addressing this pressing medical need. Its unique technology, utilizing Alnylam’s Enhanced Stabilization Chemistry Plus (ESC+) GalNAc-conjugate, enables infrequent dosing while ensuring consistent and durable blood pressure reduction.

In 2023, Roche and Alnylam established a global partnership to co-develop and co-commercialize zilebesiran. Under this agreement, Roche and Alnylam will collaborate on commercialization efforts in the U.S., while Roche has exclusive commercialization rights outside the U.S., with Chugai securing commercial rights in Japan through its agreement with Roche.

RNAi therapeutics, leveraging the natural biological process of RNA interference, represents a promising frontier in drug development, recognized with the 2006 Nobel Prize in Physiology or Medicine. By targeting disease-causing proteins at the mRNA level, RNAi therapeutics offer a potent and innovative approach to treating various conditions, including hypertension.