PARSIPPANY, N.J.--(BUSINESS WIRE)--Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed ReSTORE phase 3 global clinical trial evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis (IC) in adults. The data analyses in the article, “Outcomes by Candida spp.

新泽西州帕西帕尼——（商业新闻短讯）——梅林塔治疗有限责任公司今天宣布，已完成的ReSTORE第三阶段全球临床试验评估了REZZAYO®（注射用雷扎芬净）治疗成人念珠菌病和侵袭性念珠菌病（IC）的数据经过同行评审。文章中的数据分析，“念珠菌属的结果”。

in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis,” published in the American Society for Microbiology Antimicrobial Agents and Chemotherapy, demonstrates the efficacy of rezafungin in adult patients across a variety of Candida species. Rates of global cure and mycological eradication at day 14 and all-cause mortality at day 30 were generally comparable between the two treatment groups..

在《美国微生物抗菌剂和化学疗法学会》上发表的ReSTORE 3期试验中，雷扎芬净与卡泊芬净治疗念珠菌血症和/或侵袭性念珠菌病的对比研究表明，雷扎芬净对多种念珠菌属的成年患者有效。两个治疗组在第14天的全球治愈率和真菌学根除率以及第30天的全因死亡率通常相当。。

The article additionally highlights the approval of the Clinical and Laboratory Standards Institute (CLSI) susceptibility breakpoints for rezafungin against several Candida species including Candida glabrata, a species increasingly associated with reduced susceptibility to treatment with echinocandins, and Candida auris, a highly resistant pathogen that is associated with life-threating infections.

这篇文章还强调了临床和实验室标准研究所（CLSI）对雷扎芬净对几种念珠菌的敏感性断点的批准，包括光滑念珠菌（Candida glabrata），一种与棘白菌素治疗敏感性降低越来越相关的物种，以及金黄色念珠菌（Candida auris），一种高度耐药的病原体，与威胁生命的感染有关。

Rezafungin is the only antifungal, based on in vitro data, that has a defined susceptibility breakpoint for C. auris approved by CLSI; the efficacy of rezafungin in treating candidemia or invasive candidiasis caused by this pathogen has not been established in adequate and well-controlled clinical trials..

根据体外数据，Rezafungin是唯一一种对CLSI批准的金黄色葡萄球菌具有明确易感性断点的抗真菌药物；在充分且对照良好的临床试验中，尚未确定雷扎芬净治疗由该病原体引起的念珠菌病或侵袭性念珠菌病的疗效。。

Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, said, 'We are delighted with the release of this analysis of data from the ReSTORE Phase 3 trial, which supports the effectiveness and safety of REZZAYO in comparison to caspofungin and are also pleased to see that CLSI approved the REZZAYO susceptibility breakpoints for Candida pathogens, including C.

Melinta Therapeutics总裁兼首席执行官克里斯汀·安·米勒（Christine Ann Miller）说，“我们很高兴ReSTORE 3期试验数据分析的发布，该试验支持REZZAYO与卡泊芬净相比的有效性和安全性，也很高兴看到CLSI批准了包括C在内的念珠菌病原体的REZZAYO易感性断点。

auris, which has been identified as a potential global threat by the CDC and WHO.”.

疾病预防控制中心和世卫组织已将其确定为潜在的全球威胁。”。

She added, 'Melinta has been leveraging our expertise in hospital and acute care environments to commercialize REZZAYO, making it available to healthcare providers and their patients affected by candidemia and invasive candidiasis. This effort supports our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses.'.

她补充道，“梅林塔一直在利用我们在医院和急诊护理环境中的专业知识，将REZZAYO商业化，使其可供医疗保健提供者及其受念珠菌病和侵袭性念珠菌病影响的患者使用。这项努力支持了我们为受急性和危及生命的疾病影响的人提供创新疗法的使命。”。

Melinta holds the exclusive rights to commercialize rezafungin in the U.S. from Mundipharma.

Melinta拥有Mundipharma在美国商业化rezafungin的专有权。

About REZZAYO® (rezafungin for injection)

关于REZZAYO®（注射用rezafungin）

REZZAYO (rezafungin for injection) is a novel once weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation..

REZZAYO（注射用rezafungin）是一种新的棘白菌素，每周一次，在美国被批准用于治疗成人念珠菌病和侵袭性念珠菌病。REZZAYO目前正在研究预防接受异基因血液和骨髓移植的成年人的侵袭性真菌疾病。。

INDICATIONS AND USE

适应症和用途

REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.

REZZAYO是一种棘白菌素抗真菌药，适用于18岁或以上的患者，这些患者在治疗念珠菌病和侵袭性念珠菌病方面的选择有限或没有替代选择。该适应症的批准是基于有限的临床安全性和有效性数据。

REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

REZZAYO尚未对念珠菌引起的心内膜炎，骨髓炎和脑膜炎患者进行研究。

IMPORTANT SAFETY INFORMATION

重要安全信息

Contraindications

禁忌症

REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

REZZAYO禁用于已知对rezafungin或其他棘白菌素过敏的患者。

Warnings and Precautions

警告和注意事项

Infusion-related Reactions: REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.

输液相关反应：REZZAYO可能引起输液相关反应，包括潮红，温暖感，荨麻疹，恶心或胸闷。如果发生这些反应，请减慢或暂停输注。

Photosensitivity: REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.

光敏性：REZZAYO可能引起光敏性。建议患者使用防晒霜和其他紫外线辐射源。

Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.

肝脏不良反应：在用REZZAYO治疗的临床试验患者中发现肝脏检查异常。监测肝脏检查异常的患者，并评估患者继续接受REZZAYO治疗的风险/益处。

Adverse Reactions

不良反应

Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

最常见的不良反应（发生率≥5%）是低钾血症，发热，腹泻，贫血，呕吐，恶心，低镁血症，腹痛，便秘和低磷血症。

Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.

请参阅REZZAYO（注射用rezafungin）的完整处方信息，网址为www.REZZAYO.com。

About Melinta Therapeutics, LLC

关于Melinta Therapeutics，LLC

Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients.

Melinta Therapeutics是一家生物制药公司，致力于为受急性和危及生命的疾病影响的人提供创新疗法。我们将不断扩大的投资组合重点放在为未满足需求的患者提供服务上，因为这是我们产生最有意义影响的方式。在梅林塔，我们是致力于创新的远见者，同时立足于最重要的事情：患者。

Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO® (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit www.melinta.com..

我们的产品组合目前包括七种商业舞台产品：BAXDELA®（delafloxacin），KIMYRSA®（oritavancin），注射用米诺环素®（minocycline），ORBACTIV®（oritavancin），REZZAYO®（注射用瑞扎芬净），TOPROL-XL®（琥珀酸美托洛尔）和VABOMERE®（美罗培南和瓦博巴坦）。有关Melinta Therapeutics、我们对患者的承诺以及我们的治疗组合的更多信息，请访问www.Melinta.com。。