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Updated: May 29, 2025

Assessment of Human Natural Killer Cell Events Driven by FcγRIIIa Engagement in the Presence of Therapeutic Antibodies

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Published on: May 22, 2020

Inhibiting the alternative pathway of complement by reducing systemic complement factor B: Randomized, double-blind,

Michael L McCaleb¹, Steven G Hughes¹, Tamar R Grossman¹

¹Ionis Pharmaceuticals, 2855 Gazelle Court, Carlsbad, California 92010, USA.

|February 2, 2025

Summary

This summary is machine-generated.

Sefaxersen effectively reduced complement factor B (FB) levels in healthy volunteers, demonstrating a safe profile. These findings support its development for diseases like IgA nephropathy and geographic atrophy.

Keywords:

Antisense oligonucleotides Complement Alternative Pathway Complement factor B Therapeutics

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Published on: June 21, 2013

Area of Science:

Pharmacology
Immunology
Genetics

Background:

Overactive alternative complement pathway is linked to IgA nephropathy and geographic atrophy.
Sefaxersen is an antisense oligonucleotide targeting complement factor B (FB) mRNA.

Purpose of the Study:

To evaluate the safety and pharmacodynamics of sefaxersen in healthy volunteers.
To assess the effect of sefaxersen on complement factor B (FB) levels and alternative complement pathway activity.

Main Methods:

First-in-human, double-blind, placebo-controlled Phase 1 studies.
Subcutaneous administration of sefaxersen or placebo (single or repeated for 6 weeks).
Assessment of safety, plasma complement protein levels, and complement pathway activity.

Main Results:

Sefaxersen was safe and well-tolerated with no significant safety signals.
Mean FB levels decreased by up to 38% (single dose) and 69% (repeated dose).
FB reduction correlated with decreased alternative complement pathway activity (AH50).

Conclusions:

Sefaxersen demonstrates a favorable safety profile and potent reduction of complement factor B (FB).
The long-lasting effect supports monthly dosing for future clinical trials.
Results support further development for IgA nephropathy and geographic atrophy.