SWITZERLAND — Swiss Pharmaceutical company, Roche has recently formed a strategic partnership with Alnylam Pharmaceuticals to co-develop and commercialize a potentially revolutionary treatment for high blood pressure.
The collaboration brings forth zilebesiran, an investigational RNAi therapeutic administered subcutaneously and currently undergoing phase 2 development.
The treatment aims to address the pressing unmet needs in hypertension care, particularly in high-risk patient populations.
The agreement grants Roche exclusive commercialization rights for zilebesiran outside of the United States and joint commercialization rights within the country.
In exchange, Alnylam will receive an upfront payment of US$310 million and may become eligible for additional milestone payments.
Hypertension, a leading contributor to cardiovascular disease, afflicts over 1.2 billion adults globally.
Despite existing therapies, significant gaps in treatment options persist, especially for patients at high cardiovascular risk.
Zilebesiran operates by inhibiting the production of angiotensinogen, a pivotal protein responsible for elevating blood pressure, in the liver.
Encouraging results from a Phase I study demonstrated that zilebesiran outperformed placebo in reducing angiotensinogen levels in a dose-dependent manner.
Additionally, treatment with zilebesiran at a dose of 200 mg or higher led to sustained blood pressure reduction over 24 hours, with effects lasting up to six months.
Based on these promising findings, Alnylam believes that zilebesiran holds the potential to be a best-in-disease treatment for hypertension patients with high cardiovascular risk.
Furthermore, Roche highlighted the treatment’s potential to enhance adherence and compliance to therapy due to its potential bi-annual subcutaneous dosing regimen.
Roche expressed enthusiasm about zilebesiran’s potential, stating, “Based on the positive phase 1 data, zilebesiran could be a best-in-disease treatment and provide transformational benefit, especially for patients with hypertension at high cardiovascular risk.”
For Roche, this partnership marks a significant entry into the metabolic space, where it currently has limited involvement.
Apart from zilebesiran, Roche’s pipeline includes only one clinical-stage metabolic asset, RG6359, a treatment for Pompe disease.
Meanwhile, Alnylam is actively conducting the Phase II KARDIA program to evaluate zilebesiran’s safety and efficacy.
The program comprises KARDIA-1, a study with nearly 400 enrolled patients assessing zilebesiran as a monotherapy for mild-to-moderate hypertension, and KARDIA-2, evaluating zilebesiran in combination with one of three standard antihypertensive agents in 630 patients.
The results from these trials will contribute to the advancement of this potentially groundbreaking hypertension treatment.
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