Element Pharmaceuticals Enrolls First Patient in Global Pivotal Trial for ABP-671, a Novel Gout Treatment

Atom Therapeutics (Jiangsu New Element Medical Technology Co., Ltd.) is a Best-in-Class innovative drug R&D enterprise dedicated to the treatment of diseases in the metabolic and anti-inflammatory fields. Its core pipeline product, ABP-671 for the treatment of gout, has successfully completed the enrollment of the first patient in its global pivotal clinical trial.

This multicenter, randomized, double-blind trial enrolled 580 patients globally, including in the United States, Europe, Latin America, and the Asia-Pacific region. The study will evaluate the safety and efficacy of ABP-671 at different doses and dosing regimens.

Gout is the most common form of inflammatory arthritis, caused by chronic hyperuricemia, defined as elevated serum uric acid (sUA) levels exceeding 7 mg/dL (420 μmol/L). Beyond typical acute gout flares, gout can lead to other serious health complications, including permanent joint damage, increased risk of sudden cardiac death, renal impairment, and ocular diseases. Currently available medications for chronic gout are often associated with severe adverse effects, such as significant hepatotoxicity, nephrotoxicity leading to renal failure, heightened risk of sudden cardiac death, or severe gastrointestinal discomfort. Globally, there are over 50 million gout patients, including nearly 10 million in the United States, with prevalence rising in many countries.

ABP-671 is a small-molecule drug that lowers serum uric acid (sUA) levels by inhibiting renal urate transporter 1 (URAT1), thereby reducing renal uric acid reabsorption and increasing urinary urate excretion. Results from two Phase 2 clinical trials evaluating multiple doses of ABP-671 (ranging from 1 mg to 12 mg, administered once daily) demonstrated favorable efficacy and safety profiles. Once-daily administration of 2 mg ABP-671 may exhibit efficacy comparable to or superior to that of the maximum 80 mg doses of benzbromarone and febuxostat. In the 6 mg and 8 mg dose groups, 100% of subjects achieved the clinical treatment endpoint of sUA < 6 mg/dL. Notably, 100% of subjects achieved sUA levels < 5 mg/dL (300 μmol/L), with more than 57% and 87.5% of subjects, respectively, achieving sUA levels < 4 mg/dL (240 μmol/L); some subjects even reached sUA levels < 3 mg/dL (180 μmol/L). Following a single dose in the high-dose 12 mg group, 100% of subjects achieved sUA levels < 4 mg/dL. The pharmacological effect of ABP-671 was maintained over 24 hours, and no significant safety concerns were observed compared with the placebo group.

Dr. Shi Dongfang, Founder, Chairman, and CEO“ABP-671 demonstrates favorable efficacy, safety, and tolerability, positioning it as a potential Best-in-Class therapeutic in this field. In terms of safety, ABP-671 exhibits an excellent profile; most adverse events were Grade 1 (or mild) in severity, with an incidence rate comparable to that of the placebo group, and no serious adverse events were reported.” Dr. Shi further added, “A human mass balance clinical trial evaluating the absorption, metabolism, and excretion of the drug showed that over 90% of ABP-671 is excreted unchanged, without generating any metabolites associated with the hepatotoxicity observed with benzbromarone.”

Gout patients need to lower their serum uric acid (sUA) levels to < 6 mg/dL through urate-lowering therapy to control gout flares. In practice, sUA levels in gout patients should be maintained at 4–5 mg/dL (240–300 μmol/L), as only long-term maintenance of such low sUA levels can continuously dissolve tophi in the joints and soft tissues, thereby reducing the size and number of tophi, decreasing the frequency of acute gout attacks, and ultimately achieving functional cure. This goal is difficult to achieve with most gout medications currently available on the market.

Atom Therapeutics is a rapidly growing, innovative biopharmaceutical company dedicated to the development of Best-in-Class novel drugs for diseases in the fields of metabolism and inflammation. The company’s core product, ABP-671, is in late-stage clinical development for the treatment of chronic gout. Another small-molecule innovative drug, ABP-745, has demonstrated favorable efficacy and safety in preclinical studies for indications in anti-inflammatory and autoimmune diseases, and Investigational New Drug (IND) applications are currently underway in both China and the United States.