What's Happening?
Atom Therapeutics has dosed the first patient in its Phase 2 clinical trial evaluating lingdolinurad (ABP-671) for the treatment of chronic kidney disease (CKD) with hyperuricemia. This multicenter trial is being conducted in Australia and China. Lingdolinurad
is a highly potent and selective oral URAT1 inhibitor. Preclinical studies in animal models of CKD with hyperuricemia demonstrated that lingdolinurad significantly lowered serum uric acid (sUA) and blood urea nitrogen (BUN), and substantially improved serum creatinine levels. Previous clinical trials have shown favorable safety and tolerability profiles, and a Phase 2b study for gout in China achieved remarkable urate-lowering efficacy.
Why It's Important?
This Phase 2 trial is crucial for addressing a significant unmet medical need in the U.S. and globally. Hyperuricemia is a well-established independent risk factor for CKD, with studies indicating a 49% increased risk of developing CKD for every 1 mg/dL increase in sUA. The deposition of monosodium urate crystals can lead to microvascular disease and interstitial fibrosis, accelerating kidney function decline. Current urate-lowering therapies for CKD patients with hyperuricemia face substantial clinical limitations. If successful, lingdolinurad could offer a novel and effective treatment option, potentially slowing the progression of CKD and improving outcomes for millions of patients in the U.S. who suffer from this comorbidity.
What's Next?
Atom Therapeutics will continue to enroll patients and conduct the Phase 2 clinical trial for lingdolinurad in CKD with hyperuricemia. The company's lead product, lingdolinurad, is also undergoing pivotal Phase 3 trials in China and globally for chronic gout, hyperuricemia, tophaceous gout, and refractory gout. The results from this Phase 2 study will be critical in determining the drug's future development path for CKD. Atom Therapeutics is committed to delivering safer, more effective, and transformative medicines to patients worldwide, with other compounds like ABP-745 also in earlier stages of clinical development for inflammatory and cardiovascular diseases.
Beyond the Headlines
The initiation of this trial underscores the growing recognition of the intricate link between hyperuricemia and chronic kidney disease. Targeting URAT1, a transporter responsible for uric acid reabsorption, represents a precise pharmacological strategy to manage hyperuricemia and potentially mitigate its detrimental effects on kidney function. The global prevalence of CKD with hyperuricemia, affecting hundreds of millions, highlights the immense public health burden. A successful outcome for lingdolinurad could not only provide a new therapeutic option but also encourage earlier intervention for hyperuricemia in CKD patients, potentially altering the natural history of kidney disease progression and reducing the need for more invasive treatments like dialysis or transplantation.
