FLORENCE, Italy, October 29, 2025 / Biotech Newswire / --

意大利佛罗伦萨，2025年10月29日 /生物技术新闻社/ --

MimeTech S.r.l.

米姆科技有限公司

today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to its investigational drug

今天宣布，欧洲药品管理局（EMA）已授予其在研药物优先药物（PRIME）资格。

Udonitrectag lysine

乌冬直肠溶素

for the treatment of

用于治疗

diabetic foot ulcers (DFU)

糖尿病足溃疡 (DFU)

.

。

Existing measures for the treatment of diabetic foot ulcers achieve complete healing in only

现有的糖尿病足溃疡治疗方法只能实现完全愈合在仅仅

30–60% of cases within six months

30%-60% 的病例在六个月内

, with

，以及

40% one-year recurrence

40% 的一年复发率

and

和

amputation rates around 20–30%

截肢率约为20-30%

in complicated ulcers. This represents a

在复杂的溃疡中。 这代表了

significant unmet medical need

重要的未满足医疗需求

for innovative medicines capable of providing a clinically meaningful and durable improvement in healing and limb salvage.

针对能够提供具有临床意义且持久的愈合和肢体保全改善的创新药物。

Evidence from a

来自

6-week, randomised, single-blind, comparative Phase 1/2 study

6周、随机、单盲、对照的1/2期研究

in 24 patients with slow-healing diabetic foot ulcers testing

在24名慢愈合糖尿病足溃疡患者中进行测试

Udonitrectag lysine

乌冬直肠溶素

in addition to standard of care versus standard of care alone suggests that a

除了标准护理与单独的标准护理相比，这表明

potentially clinically meaningful treatment effect

潜在临床意义的治疗效果

addressing this unmet medical need can be achieved.

满足这一未被满足的医疗需求是可以实现的。

PRIME is a scheme run by the European Medicines Agency (EMA) to

PRIME是欧洲药品管理局（EMA）运行的一个计划，旨在

enhance support for the development of medicines that target an unmet medical need

增强对针对未满足医疗需求的药物开发的支持

. This voluntary programme is based on

。这个自愿项目基于

enhanced interaction and early dialogue

增强互动与早期对话

with developers of promising medicines to optimise development plans and

与有前景的药物开发者优化开发计划并

accelerate evaluation

加速评估

, helping these medicines reach patients earlier.

，帮助这些药物更早地送达患者手中。

“Receiving PRIME designation is an important recognition of the potential of Udonitrectag lysine to make a real difference for patients affected by diabetic foot ulcers,”

“获得PRIME认定是对Udonitrectag赖氨酸治疗糖尿病足溃疡患者潜力的重要认可，”

said Federico Cozzolino, CEO of MimeTech S.r.l.

米姆科技有限公司首席执行官费德里科·科佐利诺表示

“We look forward to working closely with EMA to advance the development of this innovative therapy and to bring it as soon as possible to patients in need.”

“我们期待与欧洲药品管理局密切合作，推动这种创新疗法的发展，并尽快将其带给有需要的患者。”

About

关于

MimeTech S.r.l.

米姆科技有限公司

MimeTech S.r.l. is a biotechnology company based in Florence, Italy, engaged in the development of innovative therapies based on

MimeTech S.r.l. 是一家总部位于意大利佛罗伦萨的生物技术公司，致力于开发基于创新疗法的技术。

neurotrophin mimetics

神经生长因子模拟物

, primarily proposed for the treatment of

，主要提议用于治疗

dermatologic, neurodegenerative, and cardiovascular diseases

皮肤病、神经退行性疾病和心血管疾病

, as well as for

，以及用于

solid organ transplant

实体器官移植

.

。

Contact

联系

MimeTech S.r.l.

米姆科技有限公司

Eloisa Perissi

艾洛伊萨·佩里西

Via della Cernaia 21

切尔纳亚街21号

I-50129 - Firenze - Italy

I-50129 - 佛罗伦萨 - 意大利

+39 3381330372

+39 3381330372

This email address is being protected from spambots. You need JavaScript enabled to view it.

该电子邮件地址正受到垃圾邮件程序的保护。您需要启用 JavaScript 才能查看它。

Keywords: Drugs, Investigational; Diabetes Mellitus; Diabetic Foot; Ulcer; Therapies, Investigational; Biotechnology; Amputation, Surgical; Italy; EMA; PRIME designation; MimeTech; Udonitrectag lysine; Diabetic foot ulcers; European Medicines Agency; Wound healing; Limb salvage; Clinical development; Phase 1/2 study; Federico Cozzolino; Neurotrophin mimetics.

关键词：药物，研究性；糖尿病；糖尿病足；溃疡；疗法，研究性；生物技术；外科截肢；意大利；欧洲药品管理局；PRIME指定；MimeTech；尿苷赖氨酸；糖尿病足溃疡；欧洲药品管理局；伤口愈合；肢体挽救；临床开发；1/2期研究；费德里科·科佐利诺；神经营养因子模拟物。

Source: Biotech Newswire

来源：生物技术通讯