By Fineline Cube 
Innovent Biologics, Inc. (HKG: 1801) and Sanegene Bio USA Inc. announced today the first‑in‑human (FIH) Phase I data for IBI3016 (Sanegene R&D code: SGB‑3908), a small‑interfering RNA (siRNA) drug that targets angiotensinogen (AGT). The results were presented at the digital poster session of the 2025 American Heart Association (AHA) Scientific Sessions.
Study Design & Key Endpoints
| Parameter | Detail |
|---|---|
| Study Type | Single‑ascending‑dose, open‑label Phase I |
| Population | Healthy volunteers (n = 48) |
| Dose Levels | 0.5 mg, 1 mg, 2 mg, 4 mg sub‑cutaneous (GalNAc‑mediated) |
| Primary Endpoint | Safety & tolerability (6‑month follow‑up) |
| Secondary Endpoints | Serum AGT reduction, systolic/diastolic BP change |
| Presentation | AHA 2025 Digital Poster Session (Nov 10) |
Efficacy Highlights
- Serum AGT: Single dose produced > 95 % maximal reduction in circulating AGT, sustained up to 6 months post‑dose.
- Blood Pressure: All dose cohorts showed significant systolic/diastolic reductions at the 3‑month mark, with the greatest effect observed in the 4 mg group (average SBP ↓ ‑12 mmHg, DBP ↓ ‑7 mmHg).
- Durability: The AGT knock‑down plateau persisted without additional dosing, indicating a potential once‑yearly regimen.
Safety Profile
| Observation | Outcome |
|---|---|
| Severe AEs / SAEs | None reported over 6 months |
| Hypotensive Events | Zero incidents |
| Overall AE Severity | Mild‑to‑moderate, reversible (e.g., injection‑site erythema, transient headache) |
| Discontinuations | None |
Technology & Strategic Implications
- Delivery Platform: Utilises Sanegene Bio’s proprietary GalNAc liver‑targeting conjugate, enabling high‑efficiency hepatocyte uptake and potent RNAi activity.
- Mechanistic Rationale: By silencing hepatic AGT, IBI3016 reduces the substrate for angiotensin‑II (Ang II) generation, delivering vasodilation and sustained BP lowering without the need for chronic daily dosing.
- Market Opportunity: Hypertension affects ≈ 1.13 billion adults worldwide. A once‑yearly siRNA therapy could capture a sizable share of the $200 billion antihypertensive market, especially among patients non‑responsive to ACE inhibitors or ARBs.
- Next Steps: A Phase IIb dose‑ranging study is slated for Q2 2026 in patients with stage 2 hypertension, followed by a global Phase III program targeting both monotherapy and combination‑therapy indications.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the development timeline, regulatory expectations, and commercial potential of IBI3016. Actual results may differ due to risks including clinical trial outcomes, regulatory approvals, and market acceptance.-Fineline Info & Tech