LONDON, May 3, 2024 /PRNewswire/ -- Omeza®, a regenerative skincare company that develops marine-based therapies for wounds that are hard to treat, today presented final data from a diabetic foot ulcer (DFU) clinical trial showing that Omeza® OCM™ plus offloading of weight on the affected foot achieved a 94 percent area reduction (PAR) rate in DFUs within twelve weeks, and a 62 percent PAR within four weeks.

伦敦，2024年5月3日/PRNewswire/--Omeza®是一家针对难以治疗的伤口开发海洋疗法的再生护肤公司，今天提供了一项糖尿病足溃疡（DFU）临床试验的最终数据，显示Omeza®OCM™加上受影响足部的减重，在12周内DFU的面积减少率（PAR）达到94%，在四周内达到62%。

PAR is considered a surrogate endpoint of complete wound healing, with a PAR of 50 percent at four weeks in diabetic wound patients considered a strong predictor of subsequent complete healing.1.

PAR被认为是完全伤口愈合的替代终点，糖尿病伤口患者四周的PAR为50%，被认为是随后完全愈合的有力预测因子。

Final data from the clinical trial are being presented at the 34th annual Conference of the European Wound Management Association (EWMA) May 1-3.

临床试验的最终数据将于5月1日至3日在欧洲伤口管理协会（EWMA）第34届年会上公布。

'Diabetic foot ulcers are one of the leading causes of mortality, morbidity, and lower extremity amputations in patients with diabetes, and the medical community continuously strives to identify novel therapies to prevent or reduce these complications and their significant burden to patients, families, and the healthcare system at large,' said Dr.

“糖尿病足溃疡是糖尿病患者死亡率、发病率和下肢截肢的主要原因之一，医学界一直在努力寻找新的疗法来预防或减少这些并发症及其对患者、家庭和整个医疗保健系统的重大负担，”Dr。

Richard Simman, Professor of Plastic Surgery at the University of Toledo College of Medicine, Jobst Vascular Institute at ProMedica Health System in Toledo, Ohio. ProMedica conducted the DFU clinical trial..

Richard Simman，俄亥俄州托莱多市托莱多大学医学院整形外科教授，俄亥俄州托莱多ProMedica Health System的Jobst血管研究所。ProMedica进行了DFU临床试验。。

'We're extremely encouraged by the final results of our clinical trial evaluating Omeza®'s OCM™ platform, which showed significant healing—and in over half the cases, complete closure—of patients' diabetic wounds in twelve weeks or less. This is a notable achievement, given the resistance to standard treatments that DFUs often display,' said Simman, principal investigator at the ProMedica clinical trial site..

“我们对评估Omeza®OCM™平台的临床试验的最终结果感到非常鼓舞，该平台显示出明显的愈合效果，在超过一半的病例中，患者的糖尿病伤口在12周或更短的时间内完全闭合。ProMedica临床试验现场的首席研究员西曼（Simman）说，鉴于DFUs经常表现出对标准治疗的抵抗力，这是一个值得注意的成就。。

In the study, 19 patients with DFUs were treated with OCM™, a drug/device containing cold water fish peptides and other pharmaceutical-grade components that create an absorbable matrix which conforms to the wound bed and supports the synthesis of new tissue. Patients also reduced or eliminated weight bearing on the affected foot, known as offloading, to support healing.

在这项研究中，19名DFUs患者接受了OCM™治疗，OCM™是一种含有冷水鱼肽和其他药物级成分的药物/装置，可产生符合伤口床并支持新组织合成的可吸收基质。患者还减少或消除了受影响足部的负重，称为卸载，以支持愈合。

A control group received current standards of wound care, including offloading, debridement, collagen, hypochlorite solution, and/or wound dressings containing silver alginate..

对照组接受当前的伤口护理标准，包括卸载，清创，胶原蛋白，次氯酸盐溶液和/或含有海藻酸银的伤口敷料。。

Final Study Results

最终研究结果

At the conclusion of the study, all subjects in the treatment group saw a PAR greater than 73%, with 3 subjects seeing a PAR of 100% at 4 weeks of treatment. Eight of fourteen subjects achieved 100% PAR at 12 weeks. Five patients had DFUs that were greater than 12 months old, and 3 of those patients had 100% PAR.

在研究结束时，治疗组的所有受试者的PAR均大于73%，其中3名受试者在治疗4周时的PAR为100%。14名受试者中有8名在12周时达到100%的PAR。5名患者的DFU大于12个月大，其中3名患者的PAR为100%。

No adverse events related to the treatment were reported during the study..

研究期间未报告与治疗相关的不良事件。。

4 WK PAR

4 WK标准杆数

12 WK PAR

12 WK标准杆数

% CLOSED

%已关闭

OCM™

OCM™

62

62

94

94

57

57

CONTROL

控制

42

42

50

50

17

17

'It is gratifying to see the positive impact of OCM™ on patients who had been struggling without resolution from ulcers that are very difficult to treat, and to demonstrate these positive results in both a real-world setting as well as in a clinical trial truly reinforces the potential of Omeza® OCM™ to fulfill an unmet need for patients with nonhealing wounds, said Desmond Bell, DPM, Chief Medical Officer at Omeza®..

Omeza®首席医疗官Desmond Bell说：“很高兴看到OCM™对那些难以治愈的溃疡患者产生了积极的影响，并且在现实环境和临床试验中都证明了这些积极的结果，真正增强了Omeza®OCM™满足不愈合伤口患者未满足需求的潜力。”。。

'All of the components in OCM™ are natural, pharmaceutical-grade ingredients that are known to be safe and have been shown to harness an individual's innate immune processes to activate healing at the site of the wound,' Bell said. 'Our ongoing in vivo and in vitro studies will further elucidate the mechanisms of action that underlie the exciting results we're accumulating in clinical trials and the real-world setting.'.

贝尔说：“OCM™中的所有成分都是天然的药物级成分，已知是安全的，并且已被证明可以利用个体的先天免疫过程来激活伤口部位的愈合。”我们正在进行的体内和体外研究将进一步阐明我们在临床试验和现实环境中积累的令人兴奋的结果的作用机制。”。

Studies to further evaluate the performance of OCM™ in patients with venous leg ulcers (VLUs) and in other wound types are underway, and ProMedica will begin recruiting patients for a VLU RCT trial starting Q4 2024.

进一步评估OCM™在静脉性腿部溃疡（VLU）和其他伤口类型患者中的表现的研究正在进行中，ProMedica将从2024年第4季度开始招募患者进行VLU RCT试验。

References:

参考文献：

1 https://www.jvascsurg.org/article/S0741-5214(22)02154-1/fulltext

1 https://www.jvascsurg.org/article/S0741-5214(22)02154-1/fulltext

About OMEZA

关于OMEZA

Omeza® is a commercial-stage regenerative skin and wound-care company that develops marine-based products comprising containing cold water fish peptides and other pharmaceutical-grade components designed to reduce inflammation, increase tissue proliferation, and support skin remodeling in adults with a range of chronic, non-healing wounds.

Omeza®是一家商业级再生皮肤和伤口护理公司，开发含有冷水鱼肽和其他药物级成分的海洋产品，旨在减轻炎症，增加组织增殖，并支持患有一系列慢性不愈合伤口的成年人的皮肤重塑。

Founded in 2014, the company currently markets OCM™ for the treatment of nonhealing wounds. OCM™ is also being evaluated in real-world settings and in multiple clinical trials to compare the effects of OCM™ versus standard of care on wound healing, pain reduction, quality of life, and other secondary endpoints in patients with diabetic ulcers, chronic venous leg ulcers, and multiple other wound types.

该公司成立于2014年，目前销售用于治疗不愈合伤口的OCM™。OCM™也正在现实环境和多项临床试验中进行评估，以比较OCM™与标准护理对糖尿病溃疡患者伤口愈合，疼痛减轻，生活质量和其他次要终点的影响，慢性静脉性腿部溃疡和其他多种伤口类型。

The company is headquartered in Sarasota, Florida, and has research, manufacturing, and analytical facilities located throughout Florida..

该公司总部位于佛罗里达州萨拉索塔，在佛罗里达州拥有研究、制造和分析设施。。

Media Contacts:Bernadette Cupitbcupit@omeza.com908-334-4554

媒体联系人：BernadetteCupitbcupit@omeza.com908-334-4554

SOURCE Omeza LLC

SOURCE Omeza有限责任公司