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Innovent and SanegeneBio Announce Phase 1 Clinical Data for IBI3016 Presented at American Heart Association (AHA) 2025 Annual Meeting
Prnewswire· 2025-11-10 00:00
Core Insights - Innovent Biologics and Sanegene Bio USA announced preliminary results from the Phase 1 clinical study of IBI3016, an experimental siRNA medicine targeting angiotensinogen mRNA, presented at the 2025 AHA scientific sessions [1][8] Study Overview - The Phase 1 study (NCT06501586/CTR20242500) was a randomized, double-blind, placebo-controlled trial assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBI3016 in healthy subjects and patients with mild hypertension [2] - As of July 1, 2025, 40 subjects were enrolled, with a median age of 37 years, 30% female, and a mean BMI of 25.2 kg/m² [3] Efficacy Results - IBI3016 achieved a maximum reduction of over 95% in serum AGT levels, with sustained inhibition for up to six months [7] - Blood pressure reductions were observed in all treated cohorts at three months post-administration, with changes in 24-hour mean ambulatory daytime systolic/diastolic BP ranging from 2.1/-5.5 mmHg to 16.7/-14.7 mmHg compared to placebo [7] Safety Profile - The safety profile of IBI3016 was favorable, with no severe or serious adverse events reported, and all adverse events were mild to moderate and reversible [5] - No hypotension events occurred during the study [5] Future Development - The Phase 1 results support the potential for biannual subcutaneous dosing for hypertension treatment, with next-step development scheduled to begin soon [6] - The collaboration between Innovent and SanegeneBio aims to address the unmet clinical need for hypertension therapies, particularly focusing on improving patient adherence and managing aldosterone escape [8][9] Industry Context - Hypertension affects approximately 1.4 billion people globally, with only about 20% effectively controlled through current treatments [9] - The increasing prevalence of hypertension is attributed to factors such as aging populations and lifestyle choices, highlighting the need for innovative treatment options [9] Product Information - IBI3016 is a GalNAc-conjugated RNAi-based medicine targeting AGT, designed to inhibit AGT synthesis in the liver, potentially leading to long-term blood pressure reduction [10] Company Background - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including oncology and cardiovascular conditions, with 16 products launched and multiple assets in clinical trials [11] - SanegeneBio, established in 2021, specializes in RNAi-based therapeutics and aims to develop innovative treatments for various diseases, including cardiometabolic conditions [13]