Atom Bioscience Receives FDA IND Clearance for Clinical Trial of ABP-745 for Acute Gout

2024-01-02

临床申请临床1期

ABP-745 is an oral small molecule drug that also has potential applications for other anti-inflammatory diseases 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. 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. 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. 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.” 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. 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. Atom is developing ABP-671, an oral small molecule URAT1 inhibitor 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. About Atom Bioscience 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 . 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: or atombp.us. View source version on businesswire.com: Contacts Business Development Contact: Roy J. Wu, MBA Sr. Vice President, Business Development Atom Bioscience and Pharmaceutical Co., Ltd Email: roy.wu@atombp.com Source: Atom Bioscience View this news release online at:

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