Innovent Biologics and Sanegene Bio USA have dosed the first participant in a Phase I first-in-human (FIH) clinical trial of IBI3016, aimed at treating hypertension.
The trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBI3016 in healthy volunteers and patients with mild hypertension.
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IBI3016 is a small interfering RNA (siRNA) drug candidate that targets angiotensinogen (AGT), a precursor of the potent vasoconstrictor angiotensin II.
In preclinical studies, IBI3016 has shown to significantly cut down serum AGT protein levels and linked biomarkers in hypertensive cynomolgus monkeys, leading to a marked and sustained reduction in blood pressure without safety concerns such as hypotension.
Developed using Sanegene Bio’s siRNA technology platform, IBI3016 is claimed to have enhanced drug potency and durability while maintaining a favourable safety and tolerability profile.
Innovent Biologics Clinical Development vice-president Dr Lei Qian said: “siRNA therapies, due to their long-acting effects and stable efficacy, hold tremendous potential in the management of chronic diseases, particularly in the cardiovascular and metabolic (CVM) therapeutic areas, where long-term disease control and management are critical.
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By GlobalData“Leveraging SanegeneBio’s strengths in siRNA drug development and Innovent’s clinical development expertise in CVM diseases, we have efficiently advanced IBI3016 into the clinic.
“We are committed to a rigorous, science-driven clinical development strategy and will work closely with SanegeneBio to advance the clinical development of IBI3016 with high quality and efficiency, and the hope to bring this innovative treatment to a wide range of hypertension patients, as well as other potential disease areas.”
In December last year, Innovent and Sanegene Bio signed a partnership to jointly develop IBI3016.
As part of this agreement, Innovent secured an exclusive option to license the rights for the future development, manufacturing, and commercialisation of IBI3016.
The latest development comes after Innovent Biologics announced positive results from the Phase III DREAMS-1 clinical trial of mazdutide (IBI362), meeting the primary and key secondary endpoints, for treating type 2 diabetes in Chinese patients.
