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AssigneeBioNTech SE
InventorsLorenzo Corsini, Vera Oberbauer, Lenka Podpera Tisakova, Timo Schwebs, Rocio Berdaguer Tarodo, Ann-Katrin Kieninger
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The present invention relates to new therapeutic uses of species-selective phage endolysins, in particular in the treatment of bacterial vaginosis (BV), even more particularly in the treatment of patients suffering from BV who previously failed a treatment with antibiotics, and/or patients suffering from BV wherein the infective bacteria are resistant to a treatment with antibiotics. The present invention also relates to pharmaceutical compositions for uses of the invention and methods of treatment using the same.
A recombinant Gardnerella-specific endolysin for use in treating bacterial vaginosis, wherein the endolysin is to be administered to a patient who previously failed a treatment with antibiotics and/or who suffers from bacterial vaginosis wherein the infective bacteria are resistant to a treatment with antibiotics, in particular wherein said antibiotics are nitroimidazole and/or Clindamycin.
The endolysin for use according to any one of the preceding claims, wherein said bacterial vaginosis is characterized by the presence of infective bacteria of the species Gardnerella vaginalis sensu stricto, Gardnerella leopoldii, Gardnerella piotii, Gardnerella swidsinskii, and/or any other species in the genus Gardnerella.
The endolysin for use according to any one of the preceding claims, wherein said endolysin has killing activity against species in the genus Gardnerella.
The endolysin for use according to any one of the preceding claims, wherein said endolysin has killing activity against Gardnerella vaginalis sensu stricto, Gardnerella leopoldii, Gardnerella piotii, and/or Gardnerella swidsinskii.
The endolysin for use according to any one of the preceding claims, wherein said endolysin has no killing activity against Lactobacilli crispatus, Lactobacilli gasseri, and/or Lactobacilli jensenii.
The endolysin for use according to any one of the preceding claims, wherein said endolysin comprises or consists of
The endolysin for use according to any one of the preceding claims, wherein said endolysin is a polypeptide having at least 80% sequence identity with the amino acid sequence as provided in SEQ ID NO:
The endolysin for use according to any one of the preceding claims, wherein said endolysin comprises or consists of
The endolysin for use according to any one of the preceding claims, wherein said endolysin comprises or consists of the amino acid sequence as provided in SEQ ID NO:
The endolysin for use according to any one of the preceding claims, which is to be administered locally into the vagina of a female subject and/or into or on the glans penis, prepuce or urethral entry of a male subject.
The endolysin for use according to any one of the preceding claims, which is to be co-administered with a compound or composition which adjust the pH of the vagina to 4.0-6.0.
A pharmaceutical composition comprising a recombinant Gardnerella-specific endolysin and optionally a pharmaceutically acceptable carrier and/or diluent for use in treating bacterial vaginosis in a patient who previously failed a treatment with antibiotics and/or who suffers from bacterial vaginosis wherein the infective bacteria are resistant to a treatment with antibiotics.
The pharmaceutical composition for use according to any one of claims 19 to 26, wherein said endolysin comprises or consists of
A method of treating bacterial vaginosis in a patient who previously failed a treatment with antibiotics and/or who suffers from bacterial vaginosis wherein the infective bacteria are resistant to a treatment with antibiotics, wherein the method comprises administering to said patient a therapeutically effective amount of a recombinant Gardnerella-specific endolysin or a pharmaceutical composition comprising a recombinant Gardnerella-specific endolysin.
Dependencies are inferred from the claim text.