A Randomized Phase 2 Study Of Mau868 Vs Placebo To Treat Bk Viremia In Kidney Transplant Recipients

S. Jordan¹, A. P. Limaye², B. Fischbach³, P. Sood⁴, S. Collette⁵, L. Gasink⁶, M. W. Fordyce⁷, C. J. Lin⁷, M. Hodges⁶, D. C. Brennan⁸

¹Cedars-Sinai Medical Center, Los Angeles, CA, ²University of Washington, Seattle, WA, ³Dallas Nephrology Associates, Inc, Dallas, TX, ⁴University of Pittsburgh Medical Center, Pittsburgh, PA, ⁵Hôpital Maisonneuve-Rosemont, Montréal, QC, Canada, ⁶previous employee/consultant for Amplyx Pharmaceuticals, San Diego, CA, ⁷Vera Therapeutics, Inc, Brisbane, CA, ⁸Johns Hopkins School of Medicine, Baltimore, MD

Meeting: 2022 American Transplant Congress

Abstract number: 9004

Keywords: Kidney transplantation, Monoclonal antibodies, Polyma virus, Viral therapy

Topic: Basic & Clinical Science » Basic & Clinical Science » 74 - Clinical Trials

Session Information

Session Name: Late Breaking: Clinical Trials

Session Type: Rapid Fire Oral Abstract

Date: Saturday, June 4, 2022

Session Time: 2:00pm-3:00pm

Presentation Time: 2:30pm-2:40pm

Location: Hynes Ballroom B

*Purpose: To assess the safety and efficacy of MAU868, a BK virus-specific monoclonal antibody, in adult kidney transplant recipients with BK viremia.

*Methods: This is a Phase 2, randomized, placebo-controlled, double-blind study in patients who received a kidney transplant within 1 year of enrollment and, within 10 days of enrollment, had BK viremia (≥10⁴ DNA copies/mL or detectable BK viral load [≥10³ copies/mL] in ≥1 of 2 samples 1 to 3 weeks apart). Patients received MAU868 or placebo intravenously (IV) every 28 days for 12 weeks, with 24 weeks follow-up. This interim analysis reports results at 12 weeks for 2 cohorts: MAU868 1350 mg IV x4 doses, and MAU868 6750 mg IV followed by MAU868 1350 mg IV x3 doses. The primary endpoint was safety; antiviral activity was assessed in secondary and post-hoc analyses.

*Results: Twenty patients received MAU868 and 8 patients received placebo; all completed 12-weeks of treatment. Baseline data were comparable between groups. MAU868 was well tolerated, with a comparable frequency of adverse events and serious adverse events between groups. The antiviral effect was higher in the MAU868 group than the placebo group (Table).

Table: Antiviral Effect of MAU868 vs Placebo at Week 12
	MAU868 (N=20)	Placebo (N=8)	P-value
Proportion of patients with a prespecified reduction of BK plasma viral load – n (%)
– by ≥1 log	11 (55%)	1 (13%)	0.040
– to	4 (20%)	0	0.172
– of <10⁴ DNA copies/mL	15 (75%)	3 (38%)	0.061
Log reduction in BK viremia – median (interquartile range [IQR]) DNA copies/mL	‑1.14 (‑1.88, -0.50)	0.37 (-0.72, 0.04)	0.051
Change in estimated glomerular filtration rate (eGFR) – median (IQR) mL/min/1.73 m²	2.0 (-5.0, 4.0)	‑6.0 (-8.5, -0.5)	0.217

*Conclusions: MAU868 was well tolerated, and demonstrated significant BK antiviral activity in kidney transplant recipients with BK viremia. These results support the further development of MAU868 as a therapy for BK viremia.

To cite this abstract in AMA style:

Jordan S, Limaye AP, Fischbach B, Sood P, Collette S, Gasink L, Fordyce MW, Lin CJ, Hodges M, Brennan DC. A Randomized Phase 2 Study Of Mau868 Vs Placebo To Treat Bk Viremia In Kidney Transplant Recipients [abstract]. Am J Transplant. 2022; 22 (suppl 3). https://atcmeetingabstracts.com/abstract/a-randomized-phase-2-study-of-mau868-vs-placebo-to-treat-bk-viremia-in-kidney-transplant-recipients/. Accessed November 23, 2024.

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