Format

Send to

Choose Destination
Lupus. 2017 Jul;26(8):825-834. doi: 10.1177/0961203316678675. Epub 2016 Nov 16.

Safety, pharmacokinetics, and pharmacodynamics of RSLV-132, an RNase-Fc fusion protein in systemic lupus erythematosus: a randomized, double-blind, placebo-controlled study.

Author information

1
1 Resolve Therapeutics, LLC, Seattle, WA, USA.
2
2 Metroplex Clinical Research Center, Dallas, TX, USA.
3
3 Altoona Center for Clinical Research, Duncansville, PA, USA.
4
4 Clinical Research of West Florida, Clearwater, FL, USA.
5
5 Michigan State University, East Lansing, MI, USA.
6
6 Center for Rheumatology, Immunology, and Arthritis, Ft. Lauderdale, FL, USA.

Abstract

Blood-borne RNA circulating in association with autoantibodies is a potent stimulator of interferon production and immune system activation. RSLV-132 is a novel fully human biologic Fc fusion protein that is comprised of human RNase fused to the Fc domain of human IgG1. The drug is designed to remain in circulation and digest extracellular RNA with the aim of preventing activation of the immune system via Toll-like receptors and the interferon pathway. The present study describes the first clinical study of nuclease therapy in 32 subjects with systemic lupus erythematosus. The drug was well tolerated with a very favorable safety profile. The approximately 19-day serum half-life potentially supports once monthly dosing. There were no subjects in the study that developed anti-RSLV-132 antibodies. Decreases in B-cell activating factor correlated with decreases in disease activity in a subset of patients.

KEYWORDS:

RNA immune complex; interferon; nuclease therapy

PMID:
27852935
DOI:
10.1177/0961203316678675
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center