Abstract: TH-PO1092
Effect of Nanoencapsulated Sirolimus Plus Pegadricase (NASP) on Kidney Outcomes: Results from the Phase 3 DISSOLVE Studies
Session Information
- CKD: Therapies, Innovations, and Insights
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Rajpal, Minesh, Southwest Kidney Institute Central Phoenix, Phoenix, Arizona, United States
- Strand, Vibeke, Stanford University, Palo Alto, California, United States
- Azeem, Rehan, Sobi Inc, Waltham, Massachusetts, United States
- Peace, Ben, Swedish Orphan Biovitrum AB publ, Stockholm, Stockholm County, Sweden
- Desai, Bhavisha, Sobi Inc, Waltham, Massachusetts, United States
- Johnson, Richard J., University of Colorado Denver, Aurora, Colorado, United States
Background
Patients with uncontrolled gout (UG) have higher odds of developing chronic kidney disease (CKD). NASP is a novel, investigational, every 4-week, sequential infusion therapy consisting of targeted immunomodulating, nanoencapsulated sirolimus (NAS) co-administered with pegadricase (a pegylated uricase). Efficacy and safety of NASP in patients with stage 3 CKD (CKD-3) have been presented (Khanna P, et al. ASN 2024). Here we report renal outcomes in patients with CKD-3.
Methods
This post-hoc analysis from DISSOLVE I and II (NCT04513366, NCT04596540) includes patients with CKD-3, randomized 1:1:1 to receive NASP (high-dose [HD]: sequential infusions, 0.15 mg/kg NAS and 0.2 mg/kg pegadricase; low-dose [LD]: sequential infusions, 0.10 mg/kg NAS and 0.2 mg/kg pegadricase) or placebo (PBO) every 4 weeks for a total of 6 treatment periods. Outcomes include renal function tests and CKD stage.
Results
Among 265 treated patients in DISSOLVE I and II, 61 had CKD-3. Across all treatment groups, median BUN levels remained consistent from baseline to Week 24 (Table). A slight improvement in median serum creatinine was observed in HD and LD NASP groups from baseline to Week 24, while PBO slightly worsened (Table). There was 1 case of proteinuria in each NASP arm, considered not drug-related. At Week 24, 5 (25%) patients in HD improved to stage 2 and 1 (5%) improved to stage 1. In LD, 5 (27.8%) improved to stage 2. In PBO, 2 (8.7%) improved to stage 2 (Table). Median BP stayed consistent amongst all three treatment groups from baseline to Week 24 (Table). Adverse events were similar to the intent-to-treat population.
Conclusion
These data show stable renal function over the study period in NASP-treated patients with more patients having an improvement in CKD stage compared to PBO. Findings here suggest NASP may be a uricase treatment option for patients with UG and CKD-3.
Funding
- Commercial Support – The DISSOLVE I & II (NCT04513366 and NCT04596540) studies were jointly funded by Sobi and Selecta Biosciences, Inc. Sobi funded Medical Writing and Editorial assistance. Sobi reviewed and provided feedback on the abstract.