JIANGSU, China I October 09, 2023 I Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing new treatments for inflammatory and metabolic diseases, announced today the first patient has been dosed in a Phase 2b/3 clinical trial of ABP-671, a novel orally administered URAT1 inhibitor, for the treatment of chronic gout.
The multicenter, randomized, double-blind trial will enroll 580 patients worldwide, including the U.S. The results from Part 1 of the study are expected to be available in Q4/2024. Part 1 will evaluate the safety and efficacy of ABP-671 at different doses and regimens. Part 2 of the study will be a confirmatory study for dosing regimens of ABP-671 selected from Part 1.
“Gout affects more than 50 million people worldwide and is on the rise in many countries,” said Atom Bioscience CEO, Chairman and Founder Dr. William Dongfang Shi. “The need for a safe and effective treatment has never been greater. We believe our unique, potent, orally-available drug, ABP-671, will be a better treatment option for patients as suggested by currently available safety and efficacy data.” ABP-671 works by reducing the abnormally high levels of serum uric acid (sUA) and increasing excretion of urate through urine.
Gout is one of the most common types of inflammatory arthritis. It is caused by long-term hyperuricemia, an excessive concentration of serum uric acid (sUA) greater than 7 mg/dL (420 μmol/L). Gout seriously affects patients’ quality of life and is associated with other serious comorbidities, including kidney function injury, increasing the probability of sudden cardiac death. Existing drugs for treating chronic gout have poor efficacy and pose serious safety issues, such as leading to kidney failure, sudden cardiac death, or severe liver toxicity.
In two Phase 2 clinical trials of ABP-671 at doses ranging from 1 mg to 12 mg once a day, ABP-671 at a dose of 1 mg had showed a substantial reduction of sUA. 100% of subjects with levels of sUA achieved the primary endpoint of < 6 mg/dL at doses of 6 mg and 8 mg. Notably, 100% of subjects also experienced sUA levels of < 5 mg/dL, and there were 57% and 87.5% of subjects with sUA levels < 4 mg/dL (240 μmol/L), respectively. Some subjects had sUA levels < 3 mg/dL (180 μmol/L).
At a dose 12 mg of ABP-671, 100% of the subjects achieved sUA levels <4 mg/dL. The two studies showed that the efficacy of ABP-671 can be maintained up to 24 hours with once daily dosing, and there were no significant adverse events compared to the placebo group.
“In terms of safety, ABP-671 is well tolerated. Its adverse events were mostly grade 1 (mild and generally not bothersome), and the incidence is comparable to that of the placebo group,” said Dr. Shi. “No severe adverse events have occurred with ABP-671 at the dose tested.”
Dr. Shi also added, “A Human Mass Balance study, which evaluates how drugs are absorbed, metabolized and excreted, showed that ABP-671 is mostly excreted in its original form and does not produce any of similar metabolites seen with benzbromarone (a currently marketed drug for gout treatment) which causes severe liver toxicity.”
Maintaining sUA levels of 5 mg/dL to 4 mg/dL in gout patients is recommended by many national gout treatment guidelines. At these levels gout tophi are re-dissolved, tophi size and quantity are reduced and eventually acute gout attacks are reduced. This is difficult for most market drugs to achieve.
About Atom Bioscience
Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd.) is a fast-growing innovative drug company, focused on development of best-in-class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, ABP-671, is in clinical development for treatment of chronic gout. Another small molecule ABP-745 has shown significant efficacy and good safety in animal models of anti-inflammation, and is expected to be in phase 1 clinical trials soon. For more information, please visit: https://www.atombp.com or atombp.us.
Phase 2b/3 clinical trial information:
(www.clinicaltrials.gov; NCT05818085)
SOURCE: Atom Bioscience
Post Views: 146
JIANGSU, China I October 09, 2023 I Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing new treatments for inflammatory and metabolic diseases, announced today the first patient has been dosed in a Phase 2b/3 clinical trial of ABP-671, a novel orally administered URAT1 inhibitor, for the treatment of chronic gout.
The multicenter, randomized, double-blind trial will enroll 580 patients worldwide, including the U.S. The results from Part 1 of the study are expected to be available in Q4/2024. Part 1 will evaluate the safety and efficacy of ABP-671 at different doses and regimens. Part 2 of the study will be a confirmatory study for dosing regimens of ABP-671 selected from Part 1.
“Gout affects more than 50 million people worldwide and is on the rise in many countries,” said Atom Bioscience CEO, Chairman and Founder Dr. William Dongfang Shi. “The need for a safe and effective treatment has never been greater. We believe our unique, potent, orally-available drug, ABP-671, will be a better treatment option for patients as suggested by currently available safety and efficacy data.” ABP-671 works by reducing the abnormally high levels of serum uric acid (sUA) and increasing excretion of urate through urine.
Gout is one of the most common types of inflammatory arthritis. It is caused by long-term hyperuricemia, an excessive concentration of serum uric acid (sUA) greater than 7 mg/dL (420 μmol/L). Gout seriously affects patients’ quality of life and is associated with other serious comorbidities, including kidney function injury, increasing the probability of sudden cardiac death. Existing drugs for treating chronic gout have poor efficacy and pose serious safety issues, such as leading to kidney failure, sudden cardiac death, or severe liver toxicity.
In two Phase 2 clinical trials of ABP-671 at doses ranging from 1 mg to 12 mg once a day, ABP-671 at a dose of 1 mg had showed a substantial reduction of sUA. 100% of subjects with levels of sUA achieved the primary endpoint of < 6 mg/dL at doses of 6 mg and 8 mg. Notably, 100% of subjects also experienced sUA levels of < 5 mg/dL, and there were 57% and 87.5% of subjects with sUA levels < 4 mg/dL (240 μmol/L), respectively. Some subjects had sUA levels < 3 mg/dL (180 μmol/L).
At a dose 12 mg of ABP-671, 100% of the subjects achieved sUA levels <4 mg/dL. The two studies showed that the efficacy of ABP-671 can be maintained up to 24 hours with once daily dosing, and there were no significant adverse events compared to the placebo group.
“In terms of safety, ABP-671 is well tolerated. Its adverse events were mostly grade 1 (mild and generally not bothersome), and the incidence is comparable to that of the placebo group,” said Dr. Shi. “No severe adverse events have occurred with ABP-671 at the dose tested.”
Dr. Shi also added, “A Human Mass Balance study, which evaluates how drugs are absorbed, metabolized and excreted, showed that ABP-671 is mostly excreted in its original form and does not produce any of similar metabolites seen with benzbromarone (a currently marketed drug for gout treatment) which causes severe liver toxicity.”
Maintaining sUA levels of 5 mg/dL to 4 mg/dL in gout patients is recommended by many national gout treatment guidelines. At these levels gout tophi are re-dissolved, tophi size and quantity are reduced and eventually acute gout attacks are reduced. This is difficult for most market drugs to achieve.
About Atom Bioscience
Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd.) is a fast-growing innovative drug company, focused on development of best-in-class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, ABP-671, is in clinical development for treatment of chronic gout. Another small molecule ABP-745 has shown significant efficacy and good safety in animal models of anti-inflammation, and is expected to be in phase 1 clinical trials soon. For more information, please visit: https://www.atombp.com or atombp.us.
Phase 2b/3 clinical trial information:
(www.clinicaltrials.gov; NCT05818085)
SOURCE: Atom Bioscience
Post Views: 146
