China-based Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd) has announced positive results from a Phase IIa clinical study for its lead product, ABP-671. The randomized, double-blind, placebo-controlled trial enrolled 54 patients with gout or hyperuricemia across six cohorts, with 7 randomized to ABP-671 and 2 to placebo per cohort. The study met its primary objective of lowering serum uric acid (sUA) levels to below 6 mg/dL, and the drug was well tolerated.
Clinical Trial Results
At a dose of 1 mg ABP-671 once daily (QD), 86% of patients reached sUA levels below 6 mg/dL. Furthermore, 100% of patients achieved sUA levels below 6 mg/dL in multiple higher-tested doses. At doses of 6 mg and 12 mg ABP-671 QD, 100% of patients saw their sUA levels drop below 5 mg/dL, and 57% and 100% respectively achieved sUA levels below 4 mg/dL. Importantly, all doses were well tolerated, and no significant safety concerns were observed.
Advancement of ABP-671
The Phase IIa Australian study’s success in meeting its primary objective and demonstrating the drug’s tolerability positions ABP-671 for further clinical development. Atom Bio is advancing pivotal clinical studies for ABP-671 in the US and other countries, aiming to bring this innovative treatment to patients with chronic gout.
Market and Therapeutic Context
Current medications in the gout therapeutics market require much higher doses to control chronic gout and are generally accompanied by serious side effects, such as severe hepatotoxicity, nephrotoxicity, higher risk of sudden death, heart disease, or gastrointestinal discomfort. ABP-671, a small molecule inhibitor of the urate transporter 1 (URAT1) protein, offers a novel approach by reducing the reabsorption of uric acid in the kidneys, thereby increasing its excretion in urine.
Company Overview
Atom Bioscience is a fast-growing innovative drug company focused on the development of best-in-class small molecule therapeutics for the treatment of inflammatory and metabolic diseases. With ABP-671 in late-stage clinical development for the treatment of chronic gout, the company is poised to make a significant impact in the field of gout management.-Fineline Info & Tech
