Diamyd®3期试验达到招募里程碑-动脉网

Recruitment milestone reached in Diamyd® Phase 3 trial

BioSpace 等信源发布 2024-04-12 16:56

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STOCKHOLM, April 12, 2024 /PRNewswire/ -- Diamyd Medical's precision medicine Phase 3 trial for Type 1 Diabetes, DIAGNODE-3, has enrolled 100 patients. To date, no serious adverse events have been reported, and no patients have discontinued the trial.

斯德哥尔摩，2024年4月12日/PRNewswire/--Diamyd Medical针对1型糖尿病的精准医学3期试验DIAGNODE-3已招募了100名患者。迄今为止，尚未报告严重不良事件，也没有患者停止试验。

'This is an important milestone in our Phase 3 trial and the notable zero dropout rate confirms our insights from previous trials regarding the safety and convinience of the treatment,' says Ulf Hannelius, President & CEO of Diamyd Medical. 'We are deeply grateful to our participants for their continued commitment to the trial and to the dedicated staff at our participating clinics for their relentless efforts.'.

Diamyd Medical总裁兼首席执行官乌尔夫·汉内利乌斯（Ulf Hannelius）说：“这是我们第三阶段试验的一个重要里程碑，值得注意的零辍学率证实了我们从以前的试验中对治疗的安全性和方便性的见解。”我们非常感谢我们的参与者对试验的持续承诺，以及我们参与诊所的敬业人员的不懈努力。”。

DIAGNODE-3, being the first ever precision medicine Phase 3 trial in type 1 diabetes, is ongoing in eight European countries and in the United States. The trial specifically enrols patients that carry the genetic HLA DR3-DQ2 haplotype, a genetic subgroup of type 1 diabetes that in previous trials has been associated with positive clinical response to Diamyd® treatment.

DIAGNODE-3是有史以来第一个针对1型糖尿病的精准医学3期试验，目前正在八个欧洲国家和美国进行。该试验专门招募携带遗传HLA DR3-DQ2单倍型的患者，该单倍型是1型糖尿病的遗传亚组，在以前的试验中，该亚组与Diamyd®治疗的阳性临床反应有关。

The antigen-specific immunotherapy Diamyd® was in February 2024 granted Fast Track designation by the FDA and has previously been granted Orphan Drug designation in the U.S..

抗原特异性免疫疗法Diamyd®于2024年2月被FDA授予快速通道指定，此前已在美国获得孤儿药指定。。

About DIAGNODE-3

关于DIAGNODE-3

The confirmatory Phase III trial DIAGNODE-3 (www.diagnode-3.com), evaluating the safety and efficacy of the antigen-specific immunotherapy Diamyd® in individuals diagnosed with Type 1 Diabetes is ongoing in the United States and in eight European countries: Sweden, Spain, the Czech Republic, the Netherlands, Germany, Poland, Hungary and Estonia..

在美国和八个欧洲国家（瑞典、西班牙、捷克共和国、荷兰、德国、波兰、匈牙利和爱沙尼亚）正在进行验证性III期试验DIAGNODE-3（www.DIAGNODE-3.com），评估抗原特异性免疫疗法Diamyd®在诊断为1型糖尿病的个体中的安全性和有效性。。

DIAGNODE-3 will enroll up to 330 individuals aged 12 to 29 years, recently diagnosed (within 6 months) with Type 1 Diabetes, who carry the HLA DR3-DQ2 haplotype, a certain genetic risk factor for Type 1 Diabetes. A further stratification for HLA haplotypes is included in order to evaluate the potential super responder group of individuals who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8.

DIAGNODE-3将招募多达330名年龄在12至29岁之间的患者，这些患者最近被诊断出（在6个月内）患有1型糖尿病，他们携带HLA DR3-DQ2单倍型，这是1型糖尿病的某种遗传危险因素。包括对HLA单倍型的进一步分层，以评估HLA DR3-DQ2阳性和HLA DR4-DQ8阴性的潜在超级应答者组。

HLA testing is well established and widely available..

HLA测试已经建立并广泛可用。。

This patient population is based on clinical efficacy and safety results from the Phase IIa and Phase IIb trials DIAGNODE-1 and DIAGNODE-2, as well as on the large-scale meta-analysis encompassing data from more than 600 individuals from previous Phase II and Phase III trials using Diamyd®. The trial design provides a high probability to reach its co-primary endpoints of preservation of endogenous insulin producing capacity measured as stimulated C-peptide and improved blood glucose control as determined by HbA1c..

该患者群体基于IIa期和IIb期试验DIAGNODE-1和DIAGNODE-2的临床疗效和安全性结果，以及大规模荟萃分析，包括来自先前II期和III期试验的600多名患者的数据。使用Diamyd®。该试验设计提供了很高的可能性，可以达到其共同主要终点，即以刺激的C肽测量的内源性胰岛素产生能力的保存，以及由HbA1c确定的改善的血糖控制。。

DIAGNODE-3 is supported in part by funding from JDRF, the leading global type 1 diabetes research and advocacy organization.

DIAGNODE-3部分由全球领先的1型糖尿病研究和倡导组织JDRF资助。

About Diamyd Medical

关于Diamyd Medical

Diamyd Medical develops precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd® is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production that has been granted Orphan Drug Designation in the U.S.

Diamyd Medical开发了用于预防和治疗1型糖尿病和LADA（成人潜伏性自身免疫性糖尿病）的精准药物疗法。Diamyd®是一种抗原特异性免疫调节疗法，用于保存内源性胰岛素的产生，已在美国被授予孤儿药称号。

as well as Fast Track Designation (Feb-2024) by the U.S. FDA. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset Type 1 Diabetes in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase IIb trial, where Diamyd® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes.

以及美国FDA的快速通道指定（2024年2月）。DIAGNODE-3是一项验证性III期临床试验，正在八个欧洲国家和美国积极招募近期发作的1型糖尿病患者。之前，在一个大型的基因预定义患者组中，在大规模的荟萃分析以及该公司的前瞻性欧洲IIb期试验中，Diamyd®直接应用于最近诊断为1型糖尿病的儿童和年轻人的浅表淋巴结。

Injections into a superficial lymphnode can be performed in minutes and is intended to optimize the immune response. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd®.

注射到浅表淋巴结可以在几分钟内完成，旨在优化免疫反应。瑞典Umeå正在开发生物制造设施，用于制造重组GAD65蛋白，这是抗原特异性免疫疗法Diamyd®的活性成分。

Diamyd Medical also develops the GABA-based investigational drug Remygen® as a component in the treatments of metabolic diseases. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB as well as in the artificial intelligence company MainlyAI AB..

Diamyd Medical还开发了基于GABA的研究药物Remygen®作为代谢疾病治疗的组成部分。Diamyd Medical是干细胞公司NextCell Pharma AB以及人工智能公司MainlyAI AB的主要股东。。

Diamyd Medical's B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser.

Diamyd Medical的B股在纳斯达克第一北方增长市场（Nasdaq First North Growth Market）以DMYD B的股票代码进行交易。FNCA Sweden AB是该公司的认证顾问。

For further information, please contact:

欲了解更多信息，请联系：

Ulf Hannelius, President and CEO

总裁兼首席执行官Ulf Hannelius

Phone: +46 736 35 42 41

电话：+46 736 35 42 41

E-mail: ulf.hannelius@diamyd.com

电子邮件：ulf.hannelius@diamyd.com

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