#China #Suzhou #Innovent #SanegeneBio #IBI3016

Innovent and SanegeneBio Announce Phase 1 Clinical Data for IBI3016 at AHA 2025

The American Heart Association (AHA) Annual Meeting 2025 in San Francisco witnessed a significant presentation from Innovent Biologics, Inc. and SanegeneBio, showcasing the promising initial results from the Phase 1 clinical study of IBI3016. This experimental small interfering RNA (siRNA) medicine targets angiotensinogen mRNA (AGT) and aims to offer a new approach to treating hypertension.

Overview of the Study

IBI3016 has been developed through a collaboration involving Innovent, a leading biopharmaceutical company based in China, and SanegeneBio, a global biotechnology firm. The Phase 1 clinical trial focused on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBI3016, with patients receiving single-dose subcutaneous administration.

Dr. Fangfang Wang from Peking University Third Hospital provided an overview of the study results during a moderated poster presentation. A total of 40 healthy volunteers and patients with mild hypertension participated in this double-blind, placebo-controlled trial, which randomized participants into five dosage cohorts.

Key Findings

The results indicated that IBI3016 successfully achieved sustained AGT mRNA suppression. A significant 95% maximum reduction in AGT levels was observed, with sustained inhibition noted for up to six months post-administration. The cohorts exhibited an impressive reduction in blood pressure, with notable changes in both daytime and nighttime readings.

Three months after the treatment, all cohorts who received IBI3016 demonstrated reductions in both systolic and diastolic blood pressure, significantly outperforming the placebo group. For example, Cohort 5 showed changes of -16.7 mmHg for systolic pressure and -14.7 mmHg for diastolic pressure, highlighting the potential effectiveness of the treatment.

Moreover, the safety profile of IBI3016 appeared to be robust, with no severe adverse events reported, and all observed adverse events being mild to moderate.

Statements from Researchers

Dr. Haiyan Li, the principal investigator, commented on the urgent need for effective hypertension treatments in China, where approximately 245 million adults are affected by the condition. With hypertension being a primary risk factor for cardiovascular diseases, the results of this trial signify a crucial step towards a new treatment paradigm.

Contributing to this sentiment, Dr. Lei Qian from Innovent emphasized the commitment to advancing innovative therapies for chronic diseases. The collaboration aims to utilize the advantages of siRNA therapies in addressing issues like poor medication adherence associated with traditional drugs.

SanegeneBio's Senior Vice President, Dr. Yuyan Jin, echoed this assertion, highlighting the unmet clinical needs of hypertensive patients worldwide and the potential of IBI3016 as a transformative solution that could redefine the current treatment landscape.

The Future of IBI3016

Given the promising Phase 1 results, both companies are optimistic about the future trajectory of IBI3016. The next steps in clinical development are scheduled to start soon, paving the way for this innovative treatment to potentially enhance patient care in managing hypertension.

Conclusion

As hypertension continues to rise globally, innovative solutions like IBI3016 could represent a significant breakthrough. The results presented at the AHA 2025 serve as a strong foundation for the ongoing development of siRNA therapies in the cardiovascular field, which may ultimately lead to improved management options for patients suffering from this common chronic condition. Both Innovent and SanegeneBio remain dedicated to refining this promising therapy as part of their commitment to advance healthcare worldwide.