Express reduces key indicators of gout, and the Phase 2a clinical results of oral innovative drugs are positive

▎WuXi AppTec Content Team Editor On March 21, 2022, Jiangsu New Element Pharmaceutical Technology Co.
, Ltd.
(Atom Bioscience) announced that a Phase 2a clinical trial of ABP-671, an innovative 1.
1 drug under development, in the treatment of chronic gout patients has obtained positive results
.

The trial met the primary endpoint of reducing patients' serum uric acid (sUA) levels to below 6 mg/dL (below the clinically defined hyperuricemia threshold of 7 mg/dL)
.

Hyperuricemia is the cause of gout
.

Notably, the trial reported no safety concerns
.

Gout is one of the most common types of inflammatory arthritis, affecting more than 55 million people worldwide, mainly affecting the joints of the lower extremities (foot, ankle and knee)
.

It is caused by hyperuricemia
.

Patients can have a sudden onset of an acute gout attack, which is caused by a buildup of urate crystals in the joint, causing a sudden, intense attack of pain, swelling, redness, and tenderness in the joint
.

Gout is often associated with a variety of diseases, including hypertension, obesity, cardiovascular disease, diabetes, etc.
, thus complicating the treatment of gout and increasing the risk of premature death
.

A high-purine diet or other dietary factors such as alcohol and fructose intake can increase serum urate levels and the risk of gout
.

Drugs currently on the market for gout treatment are often accompanied by severe side effects, such as severe liver toxicity, renal toxicity, and a higher risk of sudden death
.

Therefore, there is a significant unmet clinical need in patients with chronic gout
.

ABP-671 is a small-molecule inhibitor of urate transporter (URAT1), which is involved in renal reabsorption of uric acid
.

The currently available data prove that ABP-671, as a single-agent first-line treatment for gout patients, orally administered once a day can reduce the reabsorption of uric acid and increase the excretion of uric acid in the urine, thereby reducing the level of sUA to prevent gout attacks
.

And, in long-term treatment, this also reduces the number and size of tophi and reduces acute gout attacks
.

In addition, by maintaining normal levels of sUA, the drug also reduces the likelihood of complications related to hyperuricemia, such as diabetes, heart and kidney disease
.

ABP-671 has completed Phase 2a clinical trials overseas and is undergoing Phase 1/2a trials in China
.

▲New Elements Pharmaceutical R&D pipeline (Image source: New Elements Pharmaceuticals official website) In order to control chronic gout, the American College of Rheumatology recommends that all patients receiving uric acid-lowering therapy achieve and maintain sUA levels <6 mg/dL
.

In fact, sUA levels for the most effective treatment of gout should be in the range of 4.
0-5.
0 mg/dL
.

In the Phase 2a clinical trial, 60 patients were randomized to receive ABP-671 or placebo at dose levels of 2 mg, 4 mg or 8 mg daily
.

At enrollment, all patients in the trial had mean sUA levels greater than 8 mg/dL
.

The test results show that ABP-671 has good efficacy, safety and tolerability
.

Mean sUA levels of all three APB-671 dose groups met the primary endpoint of less than 6 mg/dL
.

Also, higher doses of ABP-671 resulted in a proportionally greater reduction in sUA levels in patients
.

"These results demonstrate that our investigational gout drug, ABP-671, significantly reduces uric acid levels, which is a major step forward in the management of chronic gout
.

" Dongfang Shi, CEO, Chairman and Founder of New Element Medicine "These findings in the clinic demonstrate that our proprietary oral molecule can be delivered at lower doses than currently approved drugs, while reducing patient uric acid to lower levels
.

Equally important, we did not observe any significant security issues
.

” Reference: [1] Atom Bioscience Announces Positive Phase 2a Results For Investigational New Drug to Treat Chronic Gout.
Retrieved March 21, 2022, from https://atombp.
us/2022/03/21/atom -bioscience-announces-positive-phase-2a-results-for-investigational-new-drug-to-treat-chronic-gout/ Disclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.

This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.

This article is also not a treatment plan recommendation
.

For guidance on treatment options, please visit a regular hospital
.