Atom Therapeutics to Present Positive Clinical Trial Data for Lead Gout Therapies at ACR Convergence 2025

Atom Therapeutics, a clinical-stage biotechnology company focused on developing innovative treatments for inflammatory and metabolic diseases, announced today that it will present two abstracts showcasing positive clinical trial data for its lead drug candidates at the American College of Rheumatology (ACR) Convergence 2025. The event will take place October 24–29, 2025, in Chicago, Illinois.

The company will share results from studies of its novel oral therapies: lingdolinurad (ABP-671), targeting chronic gout, and ABP-745, aimed at acute gout flares. Both drugs are part of Atom Therapeutics’ growing pipeline designed to address significant unmet needs in gout management.

The first abstract, titled “A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ABP-671 in Subjects with Hyperuricemia or Gout in China,” will be presented by Ullrich Schwertschlag, M.D., Ph.D., FACP, Atom’s Senior Vice President of Clinical Development. The presentation is scheduled for Tuesday, October 28, in Poster Session C, Hall F, from 10:30 a.m. to 12:30 p.m. Central Daylight Time.

The second abstract, titled “A Phase 1 Placebo-Controlled, Single (SAD) and Multiple Dose Escalation (MAD) Safety and Pharmacokinetic (PK) Study of a Novel Colchicine Analogue ABP-745 in Healthy Volunteers,” will also be presented by Dr. Schwertschlag at the same session. This study focuses on the safety, tolerability, and pharmacokinetics of ABP-745, a novel colchicine analogue designed to treat acute gout flares with potentially improved safety and efficacy compared to existing therapies.

William Dongfang Shi, Ph.D., Founder and CEO of Atom Therapeutics, commented on the upcoming presentations:

The positive findings from these studies have advanced our mission to provide meaningful relief to patients worldwide suffering from both the chronic and acute manifestations of gout. Both ABP-671 and ABP-745 have the potential to offer patients safer and more effective alternatives to current therapies, which often have limited efficacy and can be associated with serious or even life-threatening side effects.

ABP-671: Chronic Gout Therapy

ABP-671 is Atom Therapeutics’ lead candidate for the treatment of chronic gout. The Phase 2a trial enrolled 45 patients with chronic gout and mild-to-moderate kidney abnormalities. Participants were randomized into five oral dose groups, receiving 1 mg, 2 mg, 4 mg, 6 mg, or 12 mg once daily.

The trial results demonstrated dose-dependent reductions in serum uric acid (sUA), the key biomarker in gout management. All patients in the trial who received doses ranging from 2 mg to 12 mg daily achieved sUA levels below 6 mg/dL, the therapeutic target for chronic gout. Impressively, 85.7% of participants taking the lowest 1 mg dose reached a sUA level of 5 mg/dL, and higher doses further reduced sUA below 4 mg/dL in many patients.

ABP-671 was generally safe and well-tolerated, supporting further development in chronic gout patients, including those with renal impairment. Based on these encouraging results, Atom plans to enroll patients with mild-to-moderate renal dysfunction in future Phase 3 trials of ABP-671.

Additionally, a recently completed global Phase 2b study demonstrated positive top-line results for ABP-671 when compared with allopurinol and placebo, further supporting the potential of ABP-671 as a superior alternative to current therapies. These findings will help guide the design of pivotal studies aimed at confirming both the efficacy and safety of ABP-671 in larger patient populations worldwide.

ABP-745: Acute Gout Flares

ABP-745 is a novel colchicine analogue being developed for the treatment of acute gout flares. In the Phase 1 study conducted in healthy volunteers, ABP-745 was well-tolerated and displayed dose-proportional pharmacokinetics, supporting continued development for the management of acute gout attacks.

Acute gout flares are characterized by sudden, intense pain, often impacting mobility and quality of life. Current standard-of-care therapies, including traditional colchicine, can be associated with significant gastrointestinal side effects and other serious adverse events. ABP-745 aims to provide a safer, more tolerable alternative while maintaining efficacy in reducing inflammation and pain associated with gout flares.

Building on these promising Phase 1 results, Atom has recently enrolled the first patient in a multicenter Phase 2 trial evaluating ABP-745 in patients experiencing acute gout flares. The study will include sites in the United States, China, and Australia and will compare ABP-745 with placebo and colchicine, providing head-to-head data on efficacy and safety in a diverse patient population.

Significance for Gout Patients

Gout affects millions of individuals worldwide, with chronic hyperuricemia leading to joint damage, kidney disease, and recurring painful flares. Existing treatments often fall short, with limited efficacy, frequent side effects, or complex dosing requirements. Atom Therapeutics’ lead candidates—ABP-671 for chronic gout and ABP-745 for acute flares—represent a potential new generation of gout therapies that aim to overcome these challenges.

By targeting both long-term uric acid management and rapid flare relief, Atom is addressing the full spectrum of disease burden in gout patients, offering hope for improved quality of life and reduced complications associated with the condition.

The upcoming presentations at ACR Convergence 2025 provide a platform to share these promising results with the global rheumatology community, fostering dialogue and collaboration with physicians, researchers, and other stakeholders in the field of inflammatory and metabolic disease.

Looking Ahead

Atom Therapeutics remains focused on advancing its pipeline through rigorous clinical development, with the ultimate goal of delivering safe, effective, and patient-friendly treatments for gout and other inflammatory disorders. The company’s dual approach—targeting both chronic and acute manifestations—reflects a commitment to comprehensive disease management and a patient-centered strategy that could redefine the standard of care in gout therapy.

About Atom Therapeutics
Atom Therapeutics is a clinical-stage biotechnology company dedicated to developing innovative therapies for inflammatory and metabolic diseases. The company’s lead programs, ABP-671 and ABP-745, are oral therapies designed to improve the treatment landscape for chronic gout and acute gout flares, providing safer and more effective alternatives to existing op

Source Link

Share your love