Methods for the treatment of hepatitis B and hepatitis D infections
Inventors
Bazinet, Michel • Vaillant, Andrew
Assignees
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Publication Number
US-9533003-B2
Publication Date
2017-01-03
Expiration Date
Abstract
It is disclosed a method for the treatment of hepatitis B (HBV) infection or HBV/hepatitis D (HDV) co-infection, the method comprising administering to a subject in need of treatment a first pharmaceutically acceptable agent that removes the hepatitis B surface antigen from the blood and a second pharmaceutically acceptable agent which stimulates immune function.
Core Innovation
The disclosure describes a method for the treatment of hepatitis B infection or hepatitis B/hepatitis D co-infection by administering to a patient in need of such treatment a combination therapy. The combination includes at least one first pharmaceutically acceptable agent and one or more second pharmaceutically acceptable agents selected from defined sets.
The first pharmaceutically acceptable agent is directed to removing or inhibiting release or formation of hepatitis B surface antigen (HBsAg) from blood, including HBV subviral particles, using nucleic acid polymers and oligonucleotides. The described nucleic acid polymers include phosphorothioated repeat-sequence nucleic acid polymers, with examples including phosphorothioated degenerate or repeat-sequence NAPs.
The second pharmaceutically acceptable agents include thymosin α1 and pegylated interferon variants, as well as immune-stimulating compounds such as GS-9620 (ANA-773), immunostimulatory oligonucleotides, and steroid-related compounds including dehydroepiandrosterone and metabolites. The disclosure states that HBsAg removal enables synergistic, rapid increases in anti-HBsAg antibody responses and improved immunological recovery compared with monotherapy.
Claims Coverage
The independent claims cover 2 inventive features in methods for treating hepatitis B infection or hepatitis B/hepatitis D co-infection using a defined first oligonucleotide or nucleic acid polymer agent and one or more second immunotherapeutic agents, with nucleotide chemistry constraints.
Combination treatment of hepatitis B or hepatitis B/hepatitis D co-infection with defined first and second agents
A method for treating hepatitis B infection or hepatitis B/hepatitis D co-infection comprising administering at least one first pharmaceutically acceptable agent selected from specified oligonucleotides and phosphorothioated repeat nucleic acid polymers, together with one or more second pharmaceutically acceptable agents selected from thymosin α1, pegylated interferons, GS-9620, dehydroepiandrosterone, androstenediol, or androstenetriol.
Cytosine and ribose modification constrained oligonucleotide within the combination treatment
A method for treating hepatitis B infection or hepatitis B/hepatitis D co-infection comprising the same combination treatment, wherein the oligonucleotide further comprises all riboses having the 2′O methyl modification and all cytosines present as 5′methylcytosine.
The claims define combination methods using specified first-agent oligonucleotide or nucleic acid polymer options and specified second immunotherapeutic agents, with explicit 5′methylcytosine and, in one claim, 2′O methyl ribose constraints.
Stated Advantages
Enables synergistic, rapid increases in anti-HBsAg antibody responses.
Improved immunological recovery compared with monotherapy.
Outperforms monotherapy in the treatment context described.
Allows strong anti-HBsAg titers in all patients on shortened immunotherapy regimens.
Documented Applications
Treatment of hepatitis B infection.
Treatment of hepatitis B/hepatitis D co-infection.
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