Triveni Bio在 TRIV-509临床试验中首次对健康志愿者进行给药，同时发布的临床前数据进一步验证了在特应性皮炎中新的 Kallikrein 5/7生物学机制-动脉网

Triveni Bio Doses First Healthy Volunteers in Clinical Trial for TRIV-509, Coinciding with Preclinical Data Presentations Further Validating Novel Kallikrein 5/7 Biology in Atopic Dermatitis

CISION 等信源发布 2025-05-21 19:00



可切换为仅中文







Triveni Bio

特里维尼生物公司

enters the clinic with TRIV-509 and plans to initiate two additional patient studies in the second half of 2025 --

带着TRIV-509进入诊所，并计划在2025年下半年启动另外两项患者研究 --

-- Scientific presentations elucidate the importance of KLK5/7 in AD disease pathology and support advancement of second-generation bispecific antibody, TRIV-573, in IND-enabling studies --

-- 科学报告阐明了KLK5/7在AD疾病病理学中的重要性，并支持二代双特异性抗体TRIV-573在IND启用研究中的进展 --

WATERTOWN, Mass.

马萨诸塞州沃特敦

，

May 21, 2025

2025年5月21日

/PRNewswire/ --

Triveni Bio

特里维尼生物公司

, Inc., a biotechnology company focused on developing innovative antibody treatments for inflammation and immunology (I&I) disorders, today announced the initiation of dosing in healthy volunteers for its first-in-human Phase 1 clinical trial of TRIV-509. This study will assess the safety and tolerability of TRIV-509 and is the first of three clinical trials the company expects to begin in 2025 as Triveni advances its anti-kallikrein mechanism into patients with moderate-to-severe atopic dermatitis (AD)..

，是一家专注于开发炎症和免疫学（I&I）疾病创新抗体疗法的生物技术公司，今天宣布已在健康志愿者中开始其TRIV-509首次人体一期临床试验的剂量投放。本研究将评估TRIV-509的安全性和耐受性，是Triveni预计在2025年启动的三项临床试验中的第一个，随着公司将抗激肽释放酶机制推进至中度至重度特应性皮炎（AD）患者的治疗中。

'Triveni's transition into the clinic with TRIV-509 marks a significant milestone in our strategy to advance orthogonal mechanisms that deliver enhanced efficacy and convenience,' stated

“Triveni向诊所过渡并使用TRIV-509标志着我们在推进提供增强疗效和便利性的正交机制战略中迈出了重要的一步，”声明表示。

Bhaskar Srivastava

巴斯基·斯里瓦斯塔瓦

, M.D., Ph.D., Chief Medical Officer of

医学博士，哲学博士，首席医疗官

Triveni Bio

特里韦尼生物公司

。

TRIV-509 inhibits kallikreins 5 and 7 (KLK 5/7) and is being positioned as a more convenient and differentiated treatment option for AD and other barrier-related diseases.

TRIV-509抑制激肽释放酶5和7（KLK 5/7），并被定位为一种更方便、更差异化的AD及其他屏障相关疾病的治疗选择。

This milestone follows recent presentations at the Society for Investigative Dermatology (SID) 2025 Annual Meeting and the Protein Engineering & Cell Therapy Summit (PEGS).

这一里程碑是在皮肤病研究学会（SID）2025年年会和蛋白质工程与细胞治疗峰会（PEGS）上的近期展示之后达成的。

'We are also pleased to share human ex vivo data which, alongside existing in vivo data, demonstrate TRIV-509's impact on key markers of barrier integrity and epidermal differentiation, further underscoring the critical role of KLK5 and KLK7 in AD pathogenesis,' said

“我们也很高兴分享人体离体数据，这些数据与现有的体内数据一起，展示了TRIV-509对屏障完整性和表皮分化关键标志物的影响，进一步凸显了KLK5和KLK7在特应性皮炎（AD）发病机制中的关键作用，”

Jennifer Dovey

詹妮弗·多维

, Ph.D., Chief Scientific Officer of

，博士，首席科学官

Triveni Bio

特里维尼生物

。

TRIV-509 data presented at SID showed rapid improvement in skin barrier integrity and epidermal differentiation in AD patient explants. The data also showed that TRIV-509 significantly reduced epidermal thickness and abnormal maturation, markedly improved abnormal AD skin proliferation, and increased the presence of a key protein essential for skin barrier function.

在SID上展示的TRIV-509数据显示，AD患者移植物的皮肤屏障完整性和表皮分化迅速改善。数据还显示，TRIV-509显著减少了表皮厚度和异常成熟，明显改善了AD皮肤的异常增殖，并增加了对皮肤屏障功能至关重要的关键蛋白的存在。

Collectively, these data support the significant role of KLK5/7 in AD..

这些数据共同支持了KLK5/7在AD中的重要作用。

Furthermore, Triveni presented data at PEGS on TRIV-573, a next-generation bispecific antibody that inhibits both KLK5/7 and IL-13. Building upon the TRIV-509 findings, this bispecific is designed to leverage the KLK5/7 mechanism to repair the skin barrier while further reducing Th2 inflammation. Preclinical data highlighted TRIV-573's favorable design characteristics, including high affinity and long half-life..

此外，Triveni公司在PEGS会议上展示了TRIV-573的数据，这是一种下一代双特异性抗体，能够同时抑制KLK5/7和IL-13。基于TRIV-509的研究成果，这款双特异性抗体旨在利用KLK5/7机制修复皮肤屏障，同时进一步减少Th2炎症。临床前数据强调了TRIV-573的良好设计特性，包括高亲和力和长半衰期。

'We are highly encouraged by the progress of our first and potentially best-in-class pipeline and we look forward to initiating patient studies later this year,' added Dr. Srivastava.

“我们对我们首个且可能是同类最佳的管线进展感到非常鼓舞，并且我们期待在今年晚些时候开始患者研究，”Srivastava博士补充道。

About TRIV-509

关于TRIV-509

Triveni's lead program, TRIV-509 (anti-kallikreins 5 & 7), is a half-life extended monoclonal antibody being positioned for the treatment of moderate-to-severe atopic dermatitis (AD). Through its mechanism, TRIV-509 has demonstrated the ability to directly impact each key pillar of AD – barrier dysfunction, inflammation, and itch.

Triveni的主导项目TRIV-509（抗激肽释放酶5和7）是一种延长半衰期的单克隆抗体，正被定位用于治疗中度至重度特应性皮炎（AD）。通过其作用机制，TRIV-509已证明能够直接影响特应性皮炎的每个关键支柱——屏障功能障碍、炎症和瘙痒。

TRIV-509 has demonstrated superior efficacy compared to IL-4R inhibition in multiple preclinical AD models and shown rapid improvement in AD patient explants. TRIV-509 is a clinical stage program..

TRIV-509在多个临床前AD模型中展示了比IL-4R抑制更优越的疗效，并在AD患者离体组织中显示出快速改善。TRIV-509是一个临床阶段的项目。

About TRIV-573

关于TRIV-573

TRIV-573 is a half-life extended second-generation bispecific antibody which combines TRIV-509 with a highly potent anti-interleukin 13 mechanism (IL-13). IL-13 inhibition has been demonstrated in humans to improve outcomes in AD patients. TRIV-573 is currently in IND-enabling studies.

TRIV-573 是一种半衰期延长的第二代双特异性抗体，它将 TRIV-509 与一种高效的抗白细胞介素 13 机制 (IL-13) 结合起来。在人类中已证明，抑制 IL-13 能改善特应性皮炎（AD）患者的预后。TRIV-573 目前正处于 IND 申报研究阶段。

About Triveni Bio

关于Triveni Bio

Triveni Bio

特里韦尼生物公司

is a biotechnology company at the forefront of novel antibody-based therapies for immunological and inflammatory disorders. Using a genetics-informed, precision medicine approach, the company seeks to establish proof-of-concept early in the drug development process by leveraging deep insights into genetic and mechanistic biology.

是一家处于免疫和炎症性疾病新型抗体疗法前沿的生物技术公司。该公司采用基于基因信息的精准医疗方法，通过深入洞察基因和机制生物学，在药物开发过程的早期寻求建立概念验证。

To learn more, visit .

要了解更多信息，请访问。

www.triveni.bio

。

Media Contact

媒体联系人

Peg Rusconi

佩格·鲁斯科尼

, Deerfield Group

，鹿场集团

peg.rusconi@deerfieldgroup.com