Investigating potential for an oral treatment in diabetic retinopathy

研究糖尿病视网膜病变口服治疗的潜力

First patient dosed in Phase 1b/2a clinical trial

第一名患者在1b/2a期临床试验中服用

COPENHAGEN, Denmark, Jan. 25, 2024 /PRNewswire/ -- Breye Therapeutics ApS (Breye), a clinical-stage biopharmaceutical company developing novel oral therapies for retinal vascular diseases within ophthalmology, today announces the start of a phase 1b/2a clinical trial to investigate danegaptide, following oral administration, in patients suffering from diabetic macular edema (DME)..

丹麦哥本哈根，2024年1月25日/PRNewswire/-Breye Therapeutics ApS（Breye）是一家临床阶段的生物制药公司，开发用于眼科视网膜血管疾病的新型口服疗法，今天宣布开始一项1b/2a期临床试验，以研究口服达尼加肽治疗糖尿病性黄斑水肿（DME）患者。。

Breye is developing novel, oral ophthalmology drugs to address the need for more effective and less burdensome therapies for millions of patients suffering with deteriorating vision due to Diabetic Retinopathy (DR) or Age-Related Macular Degeneration (AMD). While there has been successful development of intravitreally administered products for patients with late-stage disease, treatment options are currently limited for patients in the early or moderate stages..

Breye正在开发新型口服眼科药物，以满足数百万因糖尿病视网膜病变（DR）或年龄相关性黄斑变性（AMD）而视力恶化的患者对更有效和负担更小的治疗需求。虽然已经成功开发了用于晚期疾病患者的玻璃体内给药产品，但目前对于早期或中期患者的治疗选择有限。。

As an oral therapy, danegaptide targets the core pathological events in DR, including cell-cell uncoupling, apoptotic vascular cell death and vascular leakage, at earlier stages of disease progression.

作为一种口服疗法，达尼加肽在疾病进展的早期阶段靶向DR的核心病理事件，包括细胞-细胞解偶联，凋亡性血管细胞死亡和血管渗漏。

With safety data derived from over 500 clinical trial participants, robust toxicology data, and strong non-clinical in vitro and in vivo efficacy results, there is strong support for danegaptide's potential to address the clinical core ocular pathologies of vascular leakage and capillary breakdown. The positive effects of treating these pathologies have been clinically validated..

由于来自500多名临床试验参与者的安全性数据，强大的毒理学数据以及强大的非临床体外和体内疗效结果，有力支持了达尼加肽解决血管渗漏和毛细血管破裂的临床核心眼部病变的潜力。治疗这些病理的积极作用已得到临床验证。。

The study's design is a multicenter, open-label, dose-escalating Phase 1b/2a study to assess the safety, tolerability, pharmacokinetics (PK), and early signs of biological activity following oral administration of danegaptide in participants diagnosed with DME.

该研究的设计是一项多中心，开放标签，剂量递增的1b/2a期研究，旨在评估被诊断患有DME的参与者口服达尼加肽后的安全性，耐受性，药代动力学（PK）和生物活性的早期迹象。

Ulrik Mouritzen, Chief Executive Officer of Breye Therapeutics, said: 'The launch of the Phase 1b/2a clinical trial for danegaptide represents a significant milestone towards realising our mission of developing more effective, globally accessible orally administered treatment solutions for patients at risk of vision loss and blindness.

Breye Therapeutics首席执行官Ulrik Mouritzen表示：“达尼加肽1b/2a期临床试验的启动是实现我们为有视力丧失和失明风险的患者开发更有效，全球可获得的口服治疗方案的使命的一个重要里程碑。

The burden on patients with diabetic retinopathy is significant and those who experience vision loss and blindness face threats to their physical and mental health and overall quality of life. At Breye, we are committed to help treat the disease earlier by offering effective oral therapies, to patients who currently have limited or no treatment options.' .

糖尿病视网膜病变患者的负担很重，视力丧失和失明的患者面临着身心健康和整体生活质量的威胁。在布雷耶，我们致力于为目前治疗选择有限或没有治疗选择的患者提供有效的口服疗法，以帮助早期治疗疾病。”。

Prof. Carl Regillo, MD, Director of Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University in Philadelphia, Member of the Breye Therapeutics Scientific Advisory Board, commented: 'Danegaptide has the potential to become a valuable oral treatment option for patients with Diabetic Retinopathy.

威尔斯眼科医院视网膜服务主任、费城托马斯·杰斐逊大学眼科教授、布雷耶治疗科学咨询委员会成员卡尔·雷吉洛（CarlRegillo）医学博士评论道：“达尼加肽有可能成为糖尿病视网膜病变患者有价值的口服治疗选择。

Patients should ideally be treated earlier and before the disease progresses to later stages, where laser treatments or intravitreally administered products are required.'.

理想情况下，患者应该在疾病进展到晚期之前进行早期治疗，需要激光治疗或玻璃体内给药。”。

About Breye Therapeutics

关于Breye Therapeutics

Breye is a biopharmaceutical company developing novel, oral ophthalmology drugs to address the needs of millions of patients suffering with deteriorating vision due to Diabetic Retinopathy (DR) or Age-Related Macular Degeneration (AMD), for which there are no treatments in early or moderate disease.

Breye是一家生物制药公司，开发新型口服眼科药物，以满足数百万因糖尿病视网膜病变（DR）或年龄相关性黄斑变性（AMD）而视力恶化的患者的需求，而这些患者在早期或中度疾病中没有治疗方法。

Severe diabetic retinopathy requires intravitreal injections directly into the eye, which are unpopular with patients, resulting in a significant drop out rate of about 50% after 1 year and only 40% of patients obtain an optimal response. Orally administered drugs will be less burdensome than injections, as well as potentially more effective and commercially competitive.

严重的糖尿病视网膜病变需要直接向眼睛内注射玻璃体内注射，这不受患者欢迎，导致1年后显着辍学率约为50%，只有40%的患者获得最佳反应。口服药物比注射药物负担更小，并且可能更有效和具有商业竞争力。

With its clinically de-risked safety profile, the lead program with danegaptide has potential for a short and well-accepted clinical regulatory pathway. Breye is also developing an oral P2X7R antagonist for AMD which seeks to reduce nerve damage and inflammation..

凭借其临床上降低风险的安全性，达尼加肽的领先计划有可能建立一个短而广为接受的临床监管途径。布雷耶还开发了一种用于AMD的口服P2X7R拮抗剂，旨在减少神经损伤和炎症。。

Breye raised a seed round from Novo Holdings and Sound BioVentures and received financial support from the BioInnovation Institute, the Danish Growth Foundation (Vækstfonden) and the Danish Innovation Foundation (Innovationsfonden).

Breye从Novo Holdings和Sound BioVentures筹集了一轮种子资金，并获得了生物创新研究所、丹麦增长基金会（Vækstfonden）和丹麦创新基金会（Innovationsfonden）的财政支持。

For more information, please visit: https://breye.com

有关更多信息，请访问：https://breye.com

SOURCE Breye Therapeutics

来源Breye Therapeutics