Innovent and SanegeneBio Announce First Participant Dosed in a Phase 1 Clinical Trial of IBI3016 (AGT siRNA)
Innovent Biologics (HKEX: 01801) and SanegeneBio have announced the dosing of the first participant in a Phase 1 clinical trial for IBI3016, an siRNA drug candidate targeting angiotensinogen (AGT) for hypertension treatment. The trial (NCT06501586) aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses in healthy volunteers and patients with mild hypertension.
Preclinical studies have shown that IBI3016 significantly reduces serum AGT protein levels and associated biomarkers, resulting in marked and sustained blood pressure reduction without observed safety concerns. Developed using SanegeneBio's proprietary siRNA technology platform, IBI3016 demonstrates enhanced drug potency and durability while maintaining favorable safety profiles.
Innovent Biologics (HKEX: 01801) e SanegeneBio hanno annunciato la somministrazione del primo partecipante in uno studio clinico di Fase 1 per IBI3016, un candidato farmaco siRNA che mira all'angiotensino (AGT) per il trattamento dell'ipertensione. Lo studio (NCT06501586) ha l'obiettivo di valutare la sicurezza, la tollerabilità, la farmacocinetica e la farmacodinamica di dosi crescenti in volontari sani e pazienti con ipertensione lieve.
Studi preclinici hanno dimostrato che IBI3016 riduce significativamente i livelli di proteine AGT sieriche e i biomarcatori associati, portando a una riduzione marcata e sostenuta della pressione sanguigna senza preoccupazioni di sicurezza osservate. Sviluppato utilizzando la piattaforma tecnologica proprietaria di siRNA di SanegeneBio, IBI3016 dimostra una potenza e durabilità del farmaco migliorate mantenendo profili di sicurezza favorevoli.
Innovent Biologics (HKEX: 01801) y SanegeneBio han anunciado la dosificación del primer participante en un ensayo clínico de Fase 1 para IBI3016, un candidato a medicamento de siRNA que tiene como objetivo la angiotensina (AGT) para el tratamiento de la hipertensión. El ensayo (NCT06501586) tiene como objetivo evaluar la seguridad, tolerabilidad, farmacocinética y farmacodinamia de dosis en aumento en voluntarios sanos y pacientes con hipertensión leve.
Los estudios preclínicos han demostrado que IBI3016 reduce significativamente los niveles de proteína AGT sérica y biomarcadores asociados, resultando en una disminución notable y sostenida de la presión arterial sin preocupaciones de seguridad observadas. Desarrollado utilizando la plataforma tecnológica de siRNA propietaria de SanegeneBio, IBI3016 demuestra una potencia y durabilidad del medicamento mejoradas mientras mantiene perfiles de seguridad favorables.
Innovent Biologics (HKEX: 01801)와 SanegeneBio가 1상 임상 시험의 첫 참가자 투약을 발표했습니다. IBI3016은 고혈압 치료를 위한 안지오텐시노겐(AGT)을 겨냥한 siRNA 약물 후보입니다. 이 시험(NCT06501586)은 건강한 자원봉사자와 경증 고혈압 환자의 단일 상승 용량에 대한 안전성, 내약성, 약물 동태학 및 약물 역학을 평가하는 것을 목표로 합니다.
전임상 연구에 따르면 IBI3016은 혈청 AGT 단백질 수준과 관련 바이오 마커를 상당히 감소시킵니다, 이로 인해 충분하고 지속적인 혈압 감소가 나타났으며 관찰된 안전성 우려는 없었습니다. SanegeneBio의 고유한 siRNA 기술 플랫폼을 사용하여 개발된 IBI3016은 약물의 효능과 지속성이 향상되었습니다, 동시에 유리한 안전성 프로필을 유지합니다.
Innovent Biologics (HKEX: 01801) et SanegeneBio ont annoncé la dose du premier participant dans un essai clinique de Phase 1 pour IBI3016, un candidat médicament siRNA ciblant l'angiotensinogène (AGT) pour le traitement de l'hypertension. L'essai (NCT06501586) vise à évaluer la safety, tolérance, pharmacocinétique et pharmacodynamique des doses croissantes chez des volontaires en bonne santé et des patients souffrant d'hypertension légère.
Des études précliniques ont montré qu'IBI3016 réduit significativement les niveaux de protéine AGT dans le sérum et les biomarqueurs associés, entraînant une réduction marquée et durable de la pression artérielle sans préoccupations de sécurité observées. Développé en utilisant la plateforme technologique siRNA propriétaire de SanegeneBio, IBI3016 démontre une meilleure puissance et durabilité du médicament, tout en maintenant des profils de sécurité favorables.
Innovent Biologics (HKEX: 01801) und SanegeneBio haben die Dosierung des ersten Teilnehmers in einer Phase-1-Studie angekündigt für IBI3016, einen siRNA-Arzneimittelkandidaten, der auf Angiotensinogen (AGT) zur Behandlung von Bluthochdruck abzielt. Die Studie (NCT06501586) hat das Ziel, Sicherheit, Verträglichkeit, Pharmakokinetik und Pharmakodynamik von einzelnen aufsteigenden Dosen bei gesunden Freiwilligen und Patienten mit leichter Hypertonie zu bewerten.
Präklinische Studien haben gezeigt, dass IBI3016 die Serum-AGT-Proteinlevel sowie die zugehörigen Biomarker signifikant senkt, was zu einer deutlichen und anhaltenden Senkung des Blutdrucks führt, ohne beobachtete Sicherheitsbedenken. IBI3016, entwickelt mit der proprietären siRNA-Technologieplattform von SanegeneBio, zeigt eine verbesserte Arzneimittelpotenz und -haltbarkeit und behält gleichzeitig gunstige Sicherheitsprofile.
- First participant dosed in Phase 1 clinical trial for IBI3016, a potential hypertension treatment
- Preclinical studies showed significant reduction in serum AGT protein levels and associated biomarkers
- IBI3016 demonstrated marked and sustained blood pressure reduction without observed safety concerns in preclinical studies
- Enhanced drug potency and durability reported from SanegeneBio's proprietary siRNA technology platform
- None.
SAN FRANSCISO and
IBI3016 (SanegeneBio's R&D code: SGB-3908) is an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Preclinical studies have demonstrated that IBI3016 significantly reduces serum AGT protein levels and associated biomarkers (ANG I, ANG II) in hypertensive cynomolgus monkeys, resulting in marked and sustained blood pressure reduction without observed safety concerns such as hypotension. IBI3016 is developed using SanegeneBio's next-generation proprietary siRNA technology platform, which enhances drug potency and durability while maintaining favorable safety and tolerability profiles. In December 2023, Innovent and Sanegene Bio entered into a strategic collaboration to co-develop IBI3016. Innovent also maintains an exclusive option to license the future development, manufacturing and commercialization rights of IBI3016.
This FIH study (NCT06501586) is a Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (SAD) of IBI3016 in healthy volunteers and patients with mild hypertension, aiming to support the further clinical development of IBI3016.
Dr. Lei Qian, Vice President of Clinical Development at Innovent Biologics, stated: "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. 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."
Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at SanegeneBio, stated: "Hypertension represents a significant unmet clinical need globally. IBI3016, as a transformative RNAi therapy, has demonstrated superior drug activity, sustained efficacy, and favorable safety and tolerability profiles in preclinical studies. The rapid initiation and progress of the Phase 1 study of IBI3016 would not have been possible without the strong support from the research center at Peking University Third Hospital, as well as the collaborative efforts of the clinical teams at Innovent and Sanegene. We look forward to continued close collaboration with Innovent as we diligently execute the clinical development plan for IBI3016 and achieve positive outcomes. Our ultimate goal is to fully realize the therapeutic potential of IBI3016, offering a more effective, safer, and patient-friendly treatment option for individuals with hypertension."
About Hypertension
Hypertension is a common chronic disease that currently affects over 1 billion people worldwide. It not only increases the risk of cardiovascular and cerebrovascular diseases while also potentially leading to complications such as kidney damage and impaired vision. With the aging population and the prevalence of risk factors such as obesity, lack of physical exercise, and unhealthy diet, the prevalence of hypertension is increasing globally. Effective anti-hypertension treatments exist, but they have some drawbacks. For example, patients must take anti-hypertension drugs daily, and because hypertension often has mild or no noticeable symptoms, it can lead to poor medication adherence. Poor compliance has become a major challenge in the treatment of hypertension, with less than
About IBI3016 (AGT siRNA)
IBI3016 (SanegeneBio's R&D code: SGB-3908) is an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Preclinical studies have demonstrated that IBI3016 significantly reduces serum AGT protein levels and associated biomarkers (ANG I, ANG II) in hypertensive cynomolgus monkeys, resulting in marked and sustained blood pressure reduction without observed safety concerns such as hypotension. IBI3016 is developed using SanegeneBio's next-generation proprietary siRNA technology platform, which enhances drug potency and durability while maintaining favorable safety and tolerability profiles. In December 2023, Innovent and SanegeneBio entered into a strategic collaboration to co-develop IBI3016. Innovent also maintains an exclusive option to license the future development, manufacturing and commercialization rights of IBI3016.
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.
Guided by the motto, 'Start with Integrity, Succeed through Action,' Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
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About SanegeneBio
SanegeneBio is an emerging RNAi-based company developing innovative RNA interference (RNAi) therapeutics driven by the cutting-edge delivery technology. Founded in 2021, SanegeneBio was led by a team of industry-leading experts and has operations in both the US and
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Reference
[i] Global report on hypertension: the race against a silent killer, WHO 2023, https://www.who.int/publications/i/item/9789240081062 |
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SOURCE Innovent Biologics
FAQ
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