Pharma Focus Europe

Atom Bioscience Secures FDA IND Clearance to Initiate Clinical Trial for ABP-745 Targeting Acute Gout

Tuesday, January 02, 2024

Atom Bioscience, specifically Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., a biotechnology company in the clinical stage, is making strides in the development of treatments for inflammatory and metabolic diseases. The company recently announced that the U.S. Food and Drug Administration (FDA) has given clearance for its Investigational New Drug (IND) application for ABP-745, an oral small molecule drug with anti-inflammatory properties. This drug is intended for the treatment of acute gout. Simultaneously, Atom has submitted an IND application for a Phase 1 clinical trial of ABP-745 in China, and both trials are scheduled to be conducted concurrently in the U.S. and China.

Results from preclinical trials have indicated that ABP-745 can significantly reduce inflammatory factor levels in animals. Comparative analysis with similar drugs demonstrates its high efficiency and notable safety improvements. While the initial clinical focus of ABP-745 is on acute gout, its positive effects on various inflammatory factors suggest potential applications in the development of treatments for related indications.

Dr. William Dongfang Shi, Founder, Chairman, and CEO of Atom Biosciences, highlights the significance of the IND clearance for ABP-745 in advancing the company's anti-inflammatory research. The Phase 1 trial for acute gout in the U.S. is expected to commence soon, and Atom Biosciences plans to increase investment to address unmet clinical needs related to multiple inflammatory indications.

Acute gout manifests as sudden, severe pain and swelling in joints, primarily in the lower extremities, triggered by the accumulation of urate crystals. Hyperuricemia, characterized by an excessive level of uric acid in the blood exceeding 7 mg/dL, leads to the formation of these crystals, resulting in chronic gout and recurrent acute gout flare-ups.

Gout, a prevalent form of inflammatory arthritis, affects over 50 million people globally, with a substantial and growing patient population in the U.S., Europe, Asia, and Latin America. If left untreated, chronic gout significantly impacts patients' quality of life and is associated with serious comorbidities, including kidney function injury, increasing the risk of sudden cardiac death.

Atom is also actively developing ABP-671, an oral small molecule URAT1 inhibitor designed to lower uric acid levels for treating chronic gout. This drug is currently undergoing multicenter Phase 2b/3 clinical trials globally, including in the U.S



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