Kidney Week

Abstract: TH-PO1181

Efficacy and Safety of AND017 for Treatment of Anemia in Dialysis-Dependent CKD

Session Information

• Late-Breaking Science Posters
  October 24, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Anemia and Iron Metabolism

• 200 Anemia and Iron Metabolism

Authors

• Zhu, Yusha, Kind Pharmaceuticals LLC, Redwood City, California, United States

Yusha Zhu, MD, PhD

• Ding, Xiaoqiang, Zhongshan Hospital Fudan University, Shanghai, Shanghai, China

Xiaoqiang Ding

• Wilson, Suzanne, Kind Pharmaceuticals LLC, Redwood City, California, United States

Suzanne Wilson

• Li, Xiaolu, Kind Pharmaceuticals LLC, Redwood City, California, United States

Xiaolu Li, PhD, MD

• Du, Ping, Kind Pharmaceuticals LLC, Redwood City, California, United States

Ping Du

• Zhu, Qi, Kind Pharmaceuticals LLC, Redwood City, California, United States

Qi Zhu, MD

• Block, Geoffrey A., US Renal Care Inc, Decatur, Georgia, United States

Geoffrey A. Block, MD, FASN

• Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States

Pablo E. Pergola, MD, PhD

Background

AND017 is an oral hypoxia-inducible factor prolyl-hydroxylase inhibitor developed for the treatment of renal anemia. It was evaluated in a Phase II clinical trial of patients with end-stage kidney disease (ESKD) in the US and China (NCT05265325).

Methods

This open-label, active-controlled study involved patients with ESKD receiving stable hemodialysis, home hemodialysis, or peritoneal dialysis, on stable erythropoiesis-stimulating agent (ESA) treatment for at least 6 weeks. The trial evaluated two starting dosing regimens of AND017: 10 mg three times per week (TIW) and 16 mg once per week (QW), compared to the active control ESA treatment. Patients were randomized 1:1:1 to one of the treatment groups and were treated for 20 weeks. Dose adjustment was allowed for both AND017 and ESA in the study to maintain hemoglobin (Hb) levels within the target range of 10.0-11.0 g/dL in the US or 10.0-12.0 g/dL in China.

Results

A total of 175 patients were enrolled: 59 in the AND017 10 mg TIW group, 57 in the AND017 16 mg QW group, and 59 in the ESA group. Baseline Hb levels were balanced across treatment groups. The primary efficacy outcome was the mean change in Hb levels from baseline, averaged over Weeks 17-21. AND017 TIW and QW groups demonstrated similar capability in maintaining Hb level with ESA treatment (within the non-inferiority margin).
Treatment-emergent adverse events (TEAEs) occurred in 81.4% of patients in the AND017 10 mg TIW group, 75.4% in the AND017 16 mg QW group, and 66.1% in the ESA group. Treatment-related adverse events (TRAEs) were reported in 6.8%, 10.5%, and 3.4% of patients, respectively. A total of 48 patients experienced serious adverse events (SAEs), with 32.2% patients in the AND017 10 mg TIW group, 28.2% in the AND017 16 mg QW group, and 22.0% in the ESA group; none were assessed as related to the study drug or active control.

Conclusion

AND017 was safe and well tolerated in patients with ESKD on stable dialysis. At both TIW and QW dosing frequencies, AND017 effectively maintained Hb levels within the target range after 20 weeks of treatment and demonstrated non-inferiority to ESA treatment.