ABP-745 is an oral small molecule drug with potential applications, for other inflammatory conditions such as cardiovascular disease
HANGZHOU, China–(BUSINESS WIRE)–Atom Therapeutics, a clinical stage biotechnology company developing best-in-class treatments for inflammatory and metabolic diseases, announced today it has enrolled the first patient in a multi-country Phase 2 trial of ABP-745, a novel anti-inflammatory drug, for treatment of painful acute gout flares.
Trial sites in the US, China and Australia are expected to enroll more than 200 patients in this randomized, double-blind study to evaluate the safety, efficacy and pharmacodynamics of ABP-745 in reducing the pain and swelling associated with an acute gout flare. ABP-745 dosing regimen will be compared with placebo and colchicine, a standard treatment for gout flares.
Dr. William Dongfang Shi, Founder, Chairman and CEO of Atom Therapeutics, commented, āThis study follows a Phase 1 trial in the US demonstrating that ABP-745 is safe and well tolerated and represents significant progress in our development of a new anti-inflammatory drug. ABP-745 was designed as a new chemical entity with the intention of improving efficacy without the concern for key interactions with other medications and better safety than colchicine in the treatment of acute gout flares.ā
Dr. Shi added, āWhile the first clinical indication for ABP-745 is for the treatment of acute gout flares, based on its positive inhibitory effects on various inflammatory factors such as IL-1Ī², TNF-Ī±, IL-6, and IL-18, it will also be developed for other inflammatory conditions including certain types of cardiovascular disease.ā
Acute gout flares are characterized by sudden severe pain and swelling of joints, usually in the lower extremities, triggered by a build-up of urate crystals. The formation of urate crystals is caused by an excessive level of uric acid in the blood usually greater than 7 mg/dL which leads to the development of chronic gout. Most acute gout flares occur in the big toe joint and last for up to seven to ten days before pain and swelling subside. In addition to colchicine, nonsteroidal anti-inflammatory drugs and glucocorticoids are used for the treatment for acute gout flares, but these medications can be associated with serious adverse events such as gastrointestinal discomfort, cardiovascular events, kidney injury, and osteoporosis. Another class of medications used in treatment of gout, IL-1Ī² inhibitors, also have serious side effects such as increased risk of infection, immunosuppression, and allergic reactions.
Gout is caused by hyperuricemia and it is one of the most common types of inflammatory arthritis affecting more than 60 million people worldwide. The disease has a large and growing patient population in the U.S., Europe, Asia and Latin America. Gout affects approximately 12 million patients in the U.S., with an average of 6.6 acute gout flares per year. As many gout flares are not reported, the true burden may be higher, and the number of acute gout flares in the U.S. may exceed 80 million per year.
If hyperuricemia is not controlled, the frequency and severity of acute gout flares may further worsen. Acute gout flares seriously affect the quality of life and safety of patients. Recent research reports have shown that acute gout flares are associated with an increased probability of sudden death caused by cardiovascular disease. Gout can also worsen other serious comorbidities including kidney injury.
Atomās lead product, lingdolinurad (ABP-671), is an oral small molecule URAT1 inhibitor in global multicenter Phase 2b/3 trials for chronic gout. Positive topline results show ABP-671 has achieved its primary endpoint in lowering patientsā uric acid levels and has demonstrated good safety and tolerability, positioning it as a leading candidate for best-in-class treatment of chronic gout. Read the full press release.
About Atom Therapeutics
Atom Therapeutics Co., Ltd (formerly Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd) is a fast-growing innovative clinical stage biotechnology company focused on development of best-in-class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The companyās lead product, lingdolinurad (ABP-671), is in late-stage clinical development for treatment of chronic gout. Another small molecule ABP-745, for anti-inflammatory and autoimmune conditions, is in global Phase 2 clinical trials for acute gout.
For more information, please visit: https://atomthera.us/
Contacts
Media Contact:
Daniel Eramian
Opus Biotech Communications
http://opusbiotech.com/
425-306-8716
Business Development Contact:
Roy J. Wu, MBA
Sr. Vice President, Business Development
Atom Therapeutics
Email: [email protected]
