Medical use of interferon-lambda for the treatment of fibrosis
Inventors
Johnson, Timothy Scott • TWOMEY, BREDA • Powers, Janine • KELLAR, Danielle E.
Assignees
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Publication Number
US-11975046-B2
Publication Date
2024-05-07
Expiration Date
Abstract
The present invention relates to methods for the treatment of fibrosis. The invention discloses new research which demonstrates that interferon-lambda has directly acting anti-fibrotic effects both in vitro and in vivo and may be used to provide effective new therapies for the treatment of multiple types of fibrosis.
Core Innovation
The invention relates to interferon-lambda (IFN-λ; IFN-λ1/2/3/4) showing unexpected direct anti-fibrotic activity. The disclosed approach provides a method of treating fibrosis by administering a therapeutically effective amount of a recombinant protein comprising the amino acid sequence of SEQ ID NO: 1. The described activity occurs directly in vitro and in vivo.
The method is directed to fibrosis that is renal fibrosis, lung fibrosis, small intestine fibrosis, skin fibrosis, or liver fibrosis. A distinguishing condition is that the fibrosis is not associated with a hepatitis virus infection.
The disclosure further specifies pharmaceutical/biologic embodiments of the IFN-λ recombinant protein, including pegylated forms such as Peginterferon Lambda-1a, Fc-fusions, and functional mimetics/variants/fragments. The overall concept is that administration of the IFN-λ recombinant protein with the specified sequence provides anti-fibrotic effects in models of fibrosis and in human primary cell extracellular matrix (ECM) fibrosis models.
Claims Coverage
The claims include 1 independent method claim directed to treating fibrosis using a recombinant IFN-λ protein defined by SEQ ID NO: 1, with a defining restriction that the fibrosis is not associated with hepatitis virus infection. The dependent claims refine the protein format, narrow fibrosis to specific organs, and add combination administration with another therapeutically active compound characterized as anti-fibrotic.
Recombinant protein comprising SEQ ID NO: 1 for fibrosis treatment
Administering, to a subject having fibrosis, a therapeutically effective amount of a recombinant protein comprising the amino acid sequence of SEQ ID NO: 1.
Organ-specific fibrosis indications (renal, lung, small intestine, skin, or liver)
Wherein the fibrosis is renal fibrosis, lung fibrosis, small intestine fibrosis, skin fibrosis, or liver fibrosis.
Fibrosis not associated with hepatitis virus infection
Wherein the fibrosis is not associated with a hepatitis virus infection.
Pegylated recombinant protein format
The method uses a pegylated recombinant protein.
Recombinant fusion protein format
The method uses a recombinant fusion protein.
Renal fibrosis indication
The method is specified to involve renal fibrosis.
Combination administration with another therapeutically active compound
The method further includes administering the recombinant protein together with another therapeutically active compound.
Anti-fibrotic characterization of the additional compound
Where the other therapeutically active compound is an anti-fibrotic therapeutic agent.
Across the claims, the core coverage is a method of treating fibrosis by administering a therapeutically effective amount of a recombinant protein comprising the amino acid sequence of SEQ ID NO: 1 (IFN-λ), limited to renal, lung, small intestine, skin, or liver fibrosis cases that are not associated with hepatitis virus infection, with further claim coverage for pegylated and fusion protein formats, renal-specific narrowing, and combination administration with an additional anti-fibrotic therapeutically active compound.
Stated Advantages
Provides a method for treating fibrosis using interferon-lambda with direct anti-fibrotic activity described as unexpected and occurring in vitro and in vivo.
Recombinant IFN-λ protein comprising SEQ ID NO: 1 is associated with anti-fibrotic effects in fibrosis models and human primary cell ECM fibrosis models.
Documented Applications
Treating renal fibrosis, lung fibrosis, small intestine fibrosis, skin fibrosis, or liver fibrosis in a subject, provided the fibrosis is not associated with a hepatitis virus infection.
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