CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aviceda Therapeutics, a privately held, late-stage clinical biotech company focused on developing next-generation immunomodulators by harnessing the power of glycobiology to alleviate chronic non-resolving inflammation, announced today the recent presentation of positive data about AVD-104, its lead ophthalmic clinical asset, at the EURETINA congress held in Amsterdam, Netherlands, from October 4–7, 2023..

马萨诸塞州剑桥市-（商业线）-Aviceda Therapeutics是一家私营的晚期临床生物技术公司，致力于利用糖生物学的力量缓解慢性非解决性炎症，开发下一代免疫调节剂，今天宣布最近发表关于AVD-104的积极数据，AVD-104是其主要的眼科临床资产，2023年10月4日至7日在荷兰阿姆斯特丹举行的EURETINA大会上。。

The Phase 2/3 SIGLEC trial is currently underway evaluating patients with geographic atrophy secondary to age-related macular degeneration (AMD). Updated data presented at the EURETINA congress showed continued safety of AVD-104, with no drug-related adverse events or serious adverse events thus far at three months in cohorts 1 and 2, two months in cohort 3, and one month in cohort 4.

2/3期SIGLEC试验目前正在评估继发于年龄相关性黄斑变性（AMD）的地理萎缩患者。在EURETINA大会上提交的最新数据显示AVD-104的持续安全性，迄今为止在第1组和第2组的3个月，第3组的2个月和第4组的1个月没有药物相关不良事件或严重不良事件。

No evidence of any significant dose-limiting toxicity has been observed, locally or systemically. Notably, no drug-related ocular inflammation, retinal vasculitis, choroidal neovascularization, infection, or optic nerve abnormalities were observed in any eyes..

没有观察到任何显着的剂量限制性毒性的证据，局部或全身。值得注意的是，在任何眼睛中均未观察到与药物相关的眼部炎症，视网膜血管炎，脉络膜新血管形成，感染或视神经异常。。

The presentation entitled, “Modulation of Macrophages and Complement Dysfunction in Nonexudative AMD utilizing Novel Sialic-acid Coated Nanoparticles,” was given by Baruch Kuppermann, M.D., Chair of the Department of Ophthalmology at University of California Irvine, Director of the Gavin Herbert Eye Institute, and the Roger F.

加利福尼亚大学欧文分校眼科主任，Gavin Herbert眼科研究所主任Baruch Kuppermann博士和Roger F.发表了题为“利用新型唾液酸包被的纳米颗粒调节非渗出性AMD中的巨噬细胞和补体功能障碍”的演讲。

Steinert Endowed Chair in Ophthalmology..

Steinert眼科学捐赠主席。。

Key Highlights Include:

主要亮点包括：

Safety Profile – AVD-104, the novel sialic acid–coated nanoparticle, demonstrated an excellent safety profile in an ongoing 9-month repeat-dose toxicology study in non-human primates, with no significant safety signals observed thus far with the three tested doses. All animals tolerated AVD-104 very well indicating its suitability for further development..

安全性概况-新型唾液酸包被的纳米颗粒AVD-104在正在进行的为期9个月的非人灵长类动物重复剂量毒理学研究中表现出优异的安全性，迄今为止，三种测试剂量均未观察到明显的安全性信号。所有动物对AVD-104的耐受性都很好，表明其适合进一步发育。。

Treatment Efficacy – AVD-104–treated mice experienced a significant reduction in outer nuclear layer thickness attenuation on day 7 following bright light severe retinal degeneration compared to control eyes. Treatment also reduced choroidal neovascular (CNV) lesion sizes comparable to aflibercept in a laser induced CNV mouse model..

治疗效果-AVD-104治疗的小鼠在明亮的光线严重视网膜变性后第7天与对照眼相比，外核层厚度衰减显着减少。在激光诱导的CNV小鼠模型中，治疗还减少了与阿柏西普相当的脉络膜新生血管（CNV）病变大小。。

Clinical Advancement – No dose-limiting toxicity or drug-related adverse events were reported in any eyes during Part 1 of the US Phase 2/3 SIGLEC clinical trial for AVD-104 at three months.

临床进展-在三个月的美国AVD-104 2/3 SIGLEC临床试验第1部分期间，任何眼睛均未报告剂量限制性毒性或药物相关不良事件。

“The preclinical results of the safety and efficacy data from animal models provide a strong foundation for human clinical trials,” said David Callanan, M.D., Aviceda’s Chief Medical Officer. “We are eager for the continuation of parts 1 and 2 of the US Phase 2/3 SIGLEC clinical trial for patients with AMD-related geographic atrophy.

Aviceda首席医疗官David Callanan博士说：“动物模型的安全性和有效性数据的临床前结果为人体临床试验奠定了坚实的基础。“我们渴望为AMD相关地理萎缩患者继续进行美国2/3期SIGLEC临床试验的第1部分和第2部分。

Initial data is coming in from part 1 and part 2 is scheduled to commence by the end of 2023.”.

初步数据来自第1部分，第2部分计划于2023年底开始。

Additional clinical data will be presented at the upcoming Retina Society annual meeting being held in New York, New York from October 11–14, 2023 as well as at other upcoming scientific meetings.

其他临床数据将在2023年10月11日至14日在纽约，纽约举行的即将举行的视网膜学会年会以及其他即将举行的科学会议上介绍。

Key Presentation:

主要介绍：

Thursday, October 12, 2023

2023年10月12日星期四

10:01–10:05 a.m. ET, David Chow, M.D.

美国东部时间上午10:01–10:05，David Chow，医学博士。

Modulation of Macrophages and Complement Dysfunction in Geographic Atrophy Utilizing Sialic-acid Coated Nanoparticles

利用唾液酸包被的纳米颗粒调节地理萎缩中的巨噬细胞和补体功能障碍

To learn more about the SIGLEC trial, click here.

要了解有关SIGLEC试用版的更多信息，请单击此处。

About Aviceda Therapeutics and AVD-104

关于Aviceda Therapeutics和AVD-104

www.avicedarx.com

www.avicedarx.com

Aviceda is a private, late-stage clinical biotechnology company located in Cambridge, MA, with a proprietary HALOS™ nanotechnology platform and an Investigational New Drug–cleared ophthalmic lead product, AVD-104, for the treatment of geographic atrophy secondary to age-related macular degeneration.

Aviceda是一家位于马萨诸塞州剑桥市的私人后期临床生物技术公司，拥有专有的光晕™ 纳米技术平台和研究性新药清除眼科铅产品AVD-104，用于治疗继发于年龄相关性黄斑变性的地理萎缩。

AVD-104 is a promising intravitreal glycan-coated nanoparticle with a dual mechanism of action that modulates critical inflammatory cellular and complement pathways through 1) direct inhibition of the activity of damaging phagocytic macrophages and repolarization of activated macrophages to their resolution state and 2) inhibition of complement cascade amplification.

AVD-104是一种有前途的玻璃体内聚糖包被的纳米颗粒，具有双重作用机制，通过1）直接抑制破坏性吞噬巨噬细胞的活性和活化的巨噬细胞复极化至其分辨状态来调节关键的炎性细胞和补体途径，2）抑制补体级联扩增。

AVD-104 has demonstrated robust in vitro/vivo efficacy with inhibition of both proinflammatory cellular and complement signaling pathways, and it has the potential for every 3- to 6-month dosing in humans. Outstanding safety has been demonstrated in multiple animal models, including non-human primates, in which no signs of intraocular inflammation were seen.

AVD-104已显示出强大的体外/体内功效，同时抑制促炎细胞和补体信号通路，并且有可能在人体内每3至6个月给药一次。在包括非人灵长类动物在内的多种动物模型中已经证明了优异的安全性，其中没有看到眼内炎症的迹象。

AVD-104 has also shown significant anti-neovascular activity equivalent to that of aflibercept (Eylea) in a well-established ocular choroidal neovascularization animal model. The U.S. SIGLEC Phase 2/3 clinical trial is currently actively enrolling for geographic atrophy..

在成熟的眼脉络膜新生血管动物模型中，AVD-104也显示出与阿柏西普（Eylea）相当的显着抗新生血管活性。美国SIGLEC 2/3期临床试验目前正在积极招募地理萎缩。。

Along with AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and multiple other therapeutic areas, including neurology, oncology, fibrosis and immunology.

与AVD-104一起，Aviceda在眼科和其他多个治疗领域拥有广泛的产品开发渠道，包括神经病学，肿瘤学，纤维化和免疫学。