Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical-stage biotechnology company, has announced the dosing of the first patient in a Phase 2b/3 clinical trial of ABP-671, an orally administered URAT1 inhibitor, for the treatment of chronic gout.
Here are the key details of the announcement:
- Clinical Trial: Atom Bioscience has initiated a Phase 2b/3 clinical trial of ABP-671 for the treatment of chronic gout. This trial is multicenter, randomized, and double-blind and will enroll 580 patients worldwide, including in the U.S.
- Trial Structure: The trial consists of two parts. Part 1 will evaluate the safety and efficacy of ABP-671 at different doses and regimens. Part 2 will be a confirmatory study for dosing regimens selected from Part 1.
- Expected Results: Results from Part 1 of the study are anticipated to be available in the fourth quarter of 2024.
- Mechanism of Action: ABP-671 is an orally available URAT1 inhibitor designed to reduce abnormally high levels of serum uric acid (sUA) and increase the excretion of urate through urine.
- Importance of Treatment: Gout is a common type of inflammatory arthritis caused by long-term hyperuricemia, which is characterized by excessive concentrations of sUA in the blood. Gout significantly impacts patients’ quality of life and is associated with comorbidities, including kidney function injury and an increased risk of sudden cardiac death. Current drugs for treating chronic gout have limitations in terms of efficacy and safety.
- Positive Phase 2 Data: In two Phase 2 clinical trials of ABP-671, the drug demonstrated a substantial reduction in sUA levels, with some subjects achieving sUA levels below recommended targets. The drug was well-tolerated, and adverse events were mostly mild and comparable to the placebo group.
- Safety Profile: ABP-671 has shown a favorable safety profile, with no severe adverse events occurring at the tested doses. Additionally, a Human Mass Balance study indicated that ABP-671 is primarily excreted in its original form and does not produce metabolites associated with severe liver toxicity, unlike some other gout treatments.
- Treatment Goals: The goal of gout treatment is to maintain sUA levels within a specific range (5 mg/dL to 4 mg/dL), which can help resolve gout symptoms, reduce tophi (uric acid deposits), and decrease the frequency of acute gout attacks.
Atom Bioscience’s Phase 2b/3 clinical trial represents a significant step in developing a potential treatment for chronic gout, addressing an unmet medical need for patients with this condition. The company aims to provide a safer and more effective treatment option for individuals living with gout.
About Atom Bioscience
Atom Bioscience, also known as Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., is an innovative drug company dedicated to developing cutting-edge small molecule therapeutics for the treatment of inflammatory and metabolic diseases.
The company’s primary focus is on advancing its lead product, ABP-671, through clinical development for the treatment of chronic gout. Additionally, Atom Bioscience is actively engaged in the development of another small molecule, ABP-745, which has demonstrated significant efficacy and safety in preclinical animal models of anti-inflammation. ABP-745 is expected to progress to phase 1 clinical trials in the near future.
Atom Bioscience’s commitment to developing novel therapies for inflammatory and metabolic diseases underscores its mission to address unmet medical needs and improve the lives of patients suffering from these conditions.
The initiation of clinical trials and the advancement of promising drug candidates like ABP-671 and ABP-745 demonstrate the company’s dedication to making a meaningful impact in the field of healthcare and drug development.