ROCHESTER, Minn.--(

明尼苏达州罗切斯特--(

BUSINESS WIRE

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)--RION, a clinical-stage regenerative medicine company at the forefront of exosome-based therapeutics, announced today that it has completed patient enrollment in its Phase 2 clinical trial for Purified Exosome Product™ (PEP™) in the treatment of Diabetic Foot Ulcers (DFUs). This milestone marks a significant step forward in the company’s mission to develop cutting-edge therapies addressing chronic wound care..

)--RION是一家临床阶段再生医学公司，位于基于外泌体的治疗学的前沿，今天宣布，它已经完成了纯化外泌体产品™（PEP™）治疗糖尿病足溃疡（DFU）的2期临床试验的患者登记。这一里程碑标志着该公司在开发针对慢性伤口护理的尖端疗法方面迈出了重要的一步。。

The multi-center, prospective, open-label study enrolled 59 patients across the United States. The trial is designed to evaluate the safety and efficacy of PEP™ when applied topically in conjunction with standard wound care, compared to standard care alone. Over the course of up to 12 weekly applications, key endpoints, including wound closure rates, time to healing, and overall safety, will be assessed..

这项多中心、前瞻性、开放性研究在美国招募了59名患者。该试验旨在评估PEP™与标准伤口护理联合使用时的安全性和有效性，与单独使用标准护理相比。在长达12周的每周应用过程中，将评估关键终点，包括伤口闭合率，愈合时间和总体安全性。。

DFUs remain a major complication of diabetes, affecting 18.6 million individuals globally each year, with significant associated morbidity, mortality, and financial burden

DFUs仍然是糖尿病的主要并发症，每年影响全球1860万人，并伴有严重的发病率、死亡率和经济负担

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. The cost of DFU treatment in the United States alone exceeds $13 billion annually

.仅在美国，DFU治疗的费用每年就超过130亿美元

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. Despite this urgent need, no new biologics have been approved for diabetic wound care in over two decades

尽管有这种迫切的需求，但二十多年来没有新的生物制剂被批准用于糖尿病伤口护理

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PEP™ is a proprietary, lyophilized exosome-based powder derived from human platelets. Stabilized regenerative exosomes in PEP™ are engineered to enhance the body’s natural healing mechanisms by promoting cellular growth, angiogenesis, and inflammation reduction, while also protecting vulnerable tissues—key factors in achieving successful wound healing..

PEP™是一种专有的冻干外泌体粉末，源自人血小板。。。

“We are thrilled to announce the full enrollment of our Phase 2 study, a crucial milestone in advancing PEP™ and exosome-based therapeutics,” said Atta Behfar, MD, PhD, co-founder of RION. “This achievement reflects the commitment of our clinical partners and the trial participants who are helping to move the field of regenerative medicine forward.

RION联合创始人、医学博士阿塔·贝法尔（Atta Behfar）表示：“我们很高兴宣布第二阶段研究的全部注册，这是推进PEP™和基于外泌体的疗法的关键里程碑。”。。

PEP™ has the potential to transform diabetic wound care by addressing a significant unmet need with a novel therapeutic approach.”.

PEP™有可能通过一种新的治疗方法来解决尚未满足的重大需求，从而改变糖尿病伤口护理。”。

The Phase 2 study builds on promising data from RION’s earlier Phase 1B trial conducted at Mayo Clinic, which demonstrated the safety and potential efficacy of PEP™. Upon successful completion of this trial, RION plans to initiate a pivotal Phase 3 study, with the goal of filing a Biologics License Application (BLA) with the U.S.

第二阶段研究基于RION在梅奥诊所进行的早期1B期试验的有希望的数据，该试验证明了PEP™的安全性和潜在疗效。在成功完成这项试验后，RION计划启动一项关键的第三阶段研究，目标是向美国提交生物制剂许可证申请（BLA）。

Food and Drug Administration (FDA)..

美国食品和药物管理局（FDA）。。

About RION

关于RION

RION was born out of Mayo Clinic after two decades of research and innovation. RION is located in Rochester, MN and is internationally recognized for its pioneering advancements in isolating and mass-producing platelet-derived regenerative exosomes into shelf stable PEP™.

。RION位于明尼苏达州罗切斯特，因其在分离和大量生产血小板衍生的再生外泌体到货架稳定的PEP™方面的开创性进展而获得国际认可。

RION is rewriting the regenerative medicine playbook. Our cutting-edge proprietary biomanufacturing platform crafts the future of regenerative therapy, unlocking the potent secrets within these tiny cellular messengers. RION’s regenerative PEP™ technology will be integral to the therapeutic exosome revolution..

里恩正在改写再生医学剧本。我们的尖端专有生物制造平台开创了再生疗法的未来，解开了这些微小细胞信使的强大秘密。RION的再生PEP™技术将成为治疗性外泌体革命的组成部分。。

About PEP™

关于PEP™

RION's Purified Exosome Product™ (PEP™) is a shelf stable product in a lyophilized powder derived from human platelets that contains stabilized platelet-derived regenerative exosomes. Discovered by the Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program, PEP™ is an exosome therapeutic that is designed to promote cell growth and formation of new blood vessels, while also reducing inflammation and protecting cells.

RION纯化的Exosome Product™（PEP™）是一种冻干粉末中的货架稳定产品，该粉末来自人血小板，其中含有稳定的血小板衍生的再生外泌体。由Mayo Clinic Van Cleve心脏再生医学计划发现，PEP™是一种外泌体治疗剂，旨在促进细胞生长和新血管的形成，同时减轻炎症和保护细胞。

RION and its scientific collaborators have performed extensive research showing the potential of PEP™ to heal a wide array of damaged tissue. The company is currently evaluating PEP™ in preclinical and clinical studies for several indications. While our focus remains on wound healing, multiple IND-enabling efforts in musculoskeletal, cardiovascular disease, pulmonary disease and women’s health disorders are creating new solutions where current standards of care cannot address unmet clinical needs..

RION及其科学合作者进行了广泛的研究，显示了PEP™治愈各种受损组织的潜力。该公司目前正在临床前和临床研究中评估PEP™的几种适应症。虽然我们的重点仍然是伤口愈合，但在肌肉骨骼疾病，心血管疾病，肺部疾病和女性健康疾病方面的多项IND努力正在创造新的解决方案，目前的护理标准无法满足未满足的临床需求。。

About Diabetic Foot Ulcers (DFU)

关于糖尿病足溃疡（DFU）

Diabetic Foot Ulcers (DFUs) are a severe and common complication of diabetes, characterized by wounds on the feet that are slow to heal and susceptible to infection. DFUs significantly impact the quality of life due to pain, reduced mobility, and the potential for amputation. Approximately 15-25% of people with diabetes will develop a DFU in their lifetime.

糖尿病足溃疡（DFU）是糖尿病的一种严重且常见的并发症，其特征是脚部伤口愈合缓慢且易感染。DFUs由于疼痛，行动不便和截肢的可能性而显着影响生活质量。大约15-25%的糖尿病患者在其一生中会发展成DFU。

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. Alarmingly, around 14-24% of these cases result in amputation

令人震惊的是，这些病例中约有14-24%会导致截肢

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. Furthermore, every three and a half minutes in the US, there is an amputation due to DFU

此外，在美国，每三分钟半就会有一次DFU截肢

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, highlighting the severity of this condition. The management of DFUs is challenging, with many patients experiencing recurrent ulcers. Additionally, DFU patients face a high mortality rate, with about 40% succumbing to the condition

。DFUs的管理具有挑战性，许多患者经历了复发性溃疡。此外，DFU患者的死亡率很高，约有40%死于这种情况

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. The economic burden of DFUs is substantial, imposing significant costs on healthcare systems, from direct treatment expenses to indirect costs related to loss of productivity and long-term disability.

。DFU的经济负担很重，给医疗系统带来了巨大的成本，从直接治疗费用到与生产力损失和长期残疾相关的间接成本。

References:

参考文献：

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2. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1. Erratum in: Diabetes Care. 2014 Sep;37(9):2660. PMID: 24186882

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3. Fang RC, Galiano RD. A review of becaplermin gel in the treatment of diabetic neuropathic foot ulcers. Biologics. 2008 Mar;2(1):1-12. doi: 10.2147/btt.s1338. PMID: 19707423; PMCID: PMC2727777

3.Fang RC，Galiano RD.becaplermin凝胶治疗糖尿病神经性足溃疡的综述。生物制剂。2008年3月；2（1）：1-12。doi:10.2147/btt.s1338。PMID:19707423；PMCID:PMC2727777

4. Yazdanpanah L, Shahbazian H, Nazari I, Arti HR, Ahmadi F, Mohammadianinejad SE, Cheraghian B, Hesam S. Incidence and Risk Factors of Diabetic Foot Ulcer: A Population-Based Diabetic Foot Cohort (ADFC Study)-Two-Year Follow-Up Study. Int J Endocrinol. 2018 Mar 15;2018:7631659. doi: 10.1155/2018/7631659.

4.Yazdanpanah L，Shahbazian H，Nazari I，Arti HR，Ahmadi F，Mohammadinejad SE，Cheraghian B，Hesam S.糖尿病足溃疡的发病率和危险因素：基于人群的糖尿病足队列（ADFC研究）-两年随访研究。Int J内分泌。2018年3月15日；2018:7631659。内政部：10.1155/2018/7631659。

PMID: 29736169; PMCID: PMC5875034..

PMID:29736169；PMCID:PMC5875034。。

5. Liao X, Li SH, El Akkawi MM, Fu XB, Liu HW, Huang YS. Surgical amputation for patients with diabetic foot ulcers: A Chinese expert panel consensus treatment guide. Front Surg. 2022 Nov 8;9:1003339. doi: 10.3389/fsurg.2022.1003339. PMID: 36425891; PMCID: PMC9679004

廖X，李SH，El Akkawi MM，傅XB，刘HW，黄YS。糖尿病足溃疡患者的手术截肢：中国专家小组共识治疗指南。前外科2022年11月8日；9： 1003339年。doi:10.3389/fsurg.2022.1003339。PMID:36425891；PMCID:PMC9679004

6. Amputation Prevention Alliance. (n.d.).

截肢预防联盟。（不另作说明）。

Amputation prevention alliance

截肢预防联盟

. Amputation Prevention Alliance | ADA

.截肢预防联盟| ADA

7. Jeyaraman K, Berhane T, Hamilton M, Chandra AP, Falhammar H. Mortality in patients with diabetic foot ulcer: a retrospective study of 513 cases from a single Centre in the Northern Territory of Australia. BMC Endocr Disord. 2019 Jan 3;19(1):1. doi: 10.1186/s12902-018-0327-2. PMID: 30606164; PMCID: PMC6318899..

7.Jeyaraman K，Berhane T，Hamilton M，Chandra AP，Falhammar H.糖尿病足溃疡患者的死亡率：对澳大利亚北部地区一个中心513例患者的回顾性研究。BMC内分泌疾病。2019年1月3日；19（1）：1。doi:10.1186/s12902-018-0327-2。PMID:30606164；PMCID:PMC6318899。。