-SGB-3908 demonstrates sustained and potent AGT mRNA suppression with preliminary evidence of antihypertensive efficacy after single-dose subcutaneous administration- -The clinical Phase 1 data of SGB-3908 further support the potential for biannual subcutaneous dosing for the treatment of hypertension. Next-step development is scheduled to initiate soon-
SanegeneBio, a clinical-stage biotechnology focused on developing best-in-class RNAi medicines for obesity, cardiometabolic, and autoimmune diseases, and Innovent Biologics, Inc. (Innovent), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, jointly announced that the preliminary results from the first-in-human (FIH) Phase 1 clinical study of SGB-3908 (Innovent’s R&D code: IBI3016), an experimental small interfering RNA (siRNA) medicine targeting angiotensinogen mRNA (AGT), were reported at the 2025 American Heart Association (AHA) scientific sessions. Dr. Fangfang Wang from Peking University Third Hospital, delivered the moderated digital poster presentation of the study results.
This FIH study (NCT06501586/CTR20242500) is a randomized, double-blind, placebo-controlled, single-ascending-dose trial in healthy subjects and patients with mild hypertension to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously administered SGB-3908.
As of July 1, 2025, 40 healthy subjects and mild hypertensive subjects were enrolled and randomized into 5 cohorts (each cohort had a 6:2 ratio of SGB-3908 dose group to placebo group). All subjects were Chinese, with a median age (range) of 37 years (24-54 years), 30% female, mean BMI of 25.2 kg/m², and baseline 24-hour ambulatory blood pressure (BP) mean of 122/74 mmHg. There were no significant differences in baseline characteristics across treatment groups.
Single-dose administration of SGB-3908 achieves sustained reduction in AGT levels and demonstrated initial blood pressure-lowering effects
– Following a single-dose administration, serum AGT levels were significantly and durably reduced, with a maximum reduction of over 95%, with sustained inhibition for up to six months: Cohorts 1–5 reached maximum suppression at approximately four weeks, the reductions were 91.7%, 91.4%, 94.7%, 96.2%, and 97.5%, respectively. At three months, the sustained serum AGT reductions were 91.2%, 90.0%, 93.8%, 96.5%, and 97.0% for Cohorts 1-5, respectively. At six months, the serum AGT reductions were 85.9%, 84.0%, 90.8%, 93.8%, and 96.4% for Cohorts 1-5, respectively.
– 3 months after administration, all treated cohorts demonstrated reductions in blood pressure: The 24-hour mean ambulatory daytime systolic/diastolic BP (SBP/DBP) changes from baseline were −8.8/-9.7, −2.1/0.8, −7.1/-5.5, −11.0/-12.5, and −16.7/-14.7 mmHg for Cohorts 1–5, respectively, compared to −3.2/-5.7 mmHg for placebo. Nighttime SBP/DBP changes were −9.4/-3.3, −7.1/-4.9, −15.1/-10.7, −11.6/-6.7, and −16.0/-12.9 mmHg for Cohorts 1–5, respectively, versus −5.0/-2.6 mmHg with placebo.
The safety profile was favorable, with no unexpected safety signals
– SGB-3908 demonstrated favorable safety and tolerability over 6 months. No severe adverse events (AEs) or serious adverse events (SAEs) were observed, and no hypotension events occurred. All adverse events reported were mild to moderate in severity and reversible.
Dr. Haiyan Li, the Principal Investigator of the Study and Director of Peking University Third Hospital, stated:
Hypertension is the most prevalent non-infectious disease in China, and the estimated number of adults with hypertension in China is about 245 million. At the same time, hypertension is also the primary risk factor for an increased risk of cardiovascular disease and death. Millions of deaths from cardiovascular disease complicated by hypertension each year create a significant socio-economic burden. Although there are many oral drugs for the treatment of hypertension in clinical practice, there are still problems such as poor medication adherence and aldosterone escape, resulting in a low overall blood pressure control rate. With their unique molecular advantages, siRNAs targeting AGT offer the potential to improve patient adherence and address aldosterone escape by providing durable blood pressure reduction and upstream inhibition of the renin-angiotensin-aldosterone system (RAAS). I am pleased to see the Phase 1 results of SGB-3908 presented at the AHA conference. SGB-3908 has demonstrated favorable safety and preliminary efficacy in Phase 1 study, laying a solid foundation for subsequent clinical development.
Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at SanegeneBio, stated:
There is still a huge unmet clinical need for hypertension worldwide. SGB-3908 as a transformative RNAi innovative therapeutic that promises to address existing issues such as poor adherence to traditional drugs and aldosterone escape. With the full cooperation and professional investment of the Peking University Third Hospital, Innovent and SanegeneBio, the Phase 1 study of SGB-3908 has achieved encouraging preliminary results and orally reported at the international conference. The study demonstrates that SGB-3908 exhibits a favorable safety profile, sustained AGT inhibition, and preliminary antihypertensive effects in both healthy subjects and patients with mild hypertension, strongly supporting its subsequent clinical development. In the future, we will continue to work closely with Innovent to efficiently implement the clinical development plan, strive to achieve positive results as soon as possible, fully release its therapeutic value, and bring more effective, safer and better compliant innovative treatment options to hypertensive patients.
Dr. Lei Qian, Chief R&D Officer of General Biomedicine from Innovent, stated
Innovent is committed to becoming a leader in chronic disease therapeutics, bringing innovative medicines to patients. With their long-acting effects and stable efficacy, siRNA drugs have shown great application potential in chronic conditions such as cardiometabolic diseases that require sustained, long-term management. Leveraging SanegeneBio’s expertise in siRNA drug discovery and Innovent’s extensive clinical experience in cardiovascular and metabolic diseases, we have achieved positive results from the Phase 1 clinical study of SGB-3908. The positive outcomes have reinforced our confidence as we advance to the next stage of clinical development. We will continue to uphold scientific rigor and high-quality, efficient clinical execution, collaborating closely with SanegeneBio to accelerate the development of this innovative therapy and bring meaningful benefit to people living with hypertension as soon as possible.
For more information, read the original press release.
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