JIANGSU, China--(BUSINESS WIRE)--Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing best-in-class treatments for inflammatory and metabolic diseases, announced today the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1 clinical trial of ABP-745, an anti-inflammatory oral small molecule drug, for the treatment of acute gout.

中国江苏——（商业新闻短讯）——临床阶段的生物技术公司Atom Bioscience（江苏Atom Bioscience and Pharmaceutical Co.，Ltd.）今天宣布，美国食品和药物管理局（FDA）已批准其ABP-745一期临床试验的研究性新药（IND）申请，一种抗炎口服小分子药物，用于治疗急性痛风。

Atom also has submitted an IND application for a Phase 1 clinical of ABP-745 in China. The studies will be conducted concurrently in the U.S. and China..

Atom还提交了在中国进行ABP-745一期临床的IND申请。这些研究将在美国和中国同时进行。。

Preclinical trial results showed that ABP-745 can significantly reduce the levels of inflammatory factors in animals, and compared with similar drugs, it has good efficiency and significant safety improvement. While the early clinical indication for ABP-745 will be for the treatment of acute gout, based on its positive inhibitory effects on various inflammatory factors, it will also be used for development of other related indications..

临床前试验结果表明，ABP-745可显着降低动物体内炎症因子的水平，与同类药物相比，具有良好的疗效和显着的安全性改善。虽然ABP-745的早期临床适应症将用于治疗急性痛风，但基于其对各种炎症因子的积极抑制作用，它也将用于开发其他相关适应症。。

Dr. William Dongfang Shi, Founder, Chairman and CEO of Atom Biosciences, said, “The IND clearance of ABP-745 is important progress in the anti-inflammatory research field of Atom Bioscience’s clinical development. We expect to begin the Phase 1 trial for acute gout in the U.S. soon. In the future the company will increase investment in multiple inflammatory indications to address unmet clinical needs and enrich and improve the company product line.”.

Atom Biosciences创始人、董事长兼首席执行官William Dongfang Shi博士表示，“ABP-745的IND清除是Atom Bioscience临床开发抗炎研究领域的重要进展。我们预计不久将在美国开始急性痛风的1期临床试验。未来，该公司将增加对多种炎症适应症的投资，以解决未满足的临床需求，并丰富和改进公司的产品线。”。

Acute gout is characterized by sudden severe pain and swelling in joints, usually in the lower extremities, triggered by the build-up of urate crystals. The formation of the urate crystals is caused by hyperuricemia, an excessive level of uric acid in the blood greater than 7 mg/dL which leads to the development of chronic gout and repeated episodes of acute gout flare-ups..

急性痛风的特征是突然剧烈疼痛和关节肿胀，通常在下肢，由尿酸盐晶体的积累引发。尿酸盐晶体的形成是由高尿酸血症引起的，高尿酸血症是血液中尿酸水平过高超过7 mg/dL，导致慢性痛风的发展和急性痛风发作的反复发作。。

Gout is one of the most common types of inflammatory arthritis affecting more than 50 million people worldwide. The disease has a large and growing patient population in the U.S., Europe, Asia and Latin America. If left untreated, chronic gout can seriously affect patients’ quality of life and is associated with other serious comorbidities, including kidney function injury, increasing the probability of sudden cardiac death..

痛风是影响全球5000多万人的最常见的炎性关节炎类型之一。该疾病在美国、欧洲、亚洲和拉丁美洲的患者人数众多且不断增长。如果不及时治疗，慢性痛风会严重影响患者的生活质量，并伴有其他严重的合并症，包括肾功能损伤，增加心源性猝死的可能性。。

Atom is developing ABP-671, an oral small molecule URAT1 inhibitor, for treatment of chronic gout. The drug, which is designed to lower uric acid levels, is in multicenter Phase 2b/3 clinical trials worldwide, including the U.S.

Atom正在开发口服小分子URAT1抑制剂ABP-671，用于治疗慢性痛风。该药物旨在降低尿酸水平，目前正在全球进行多中心2b/3期临床试验，包括美国。

About Atom Bioscience

关于原子生物科学

Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd.) is a fast-growing innovative drug company, focused on development of best-in-class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, ABP-671, is in Phase 2b/3 clinical development for treatment of chronic gout .

Atom Bioscience（江苏Atom Bioscience and Pharmaceutical Co.Ltd.）是一家快速发展的创新药物公司，专注于开发用于治疗炎症和代谢疾病的一流小分子疗法。该公司的主导产品ABP-671正处于治疗慢性痛风的2b/3期临床开发阶段。

Another small molecule ABP-745 has shown significant efficacy and good safety in animal models of anti-inflammation, and is expected to be in Phase 1 clinical trials soon. For more information, please visit: www.atombp.com or atombp.us..

另一种小分子ABP-745在抗炎动物模型中显示出显着的功效和良好的安全性，预计很快将进入1期临床试验。有关更多信息，请访问：www.atombp.com或atombp.us。。