Intravaginal formulations of gardnerella endolysins
AssigneeBioNTech SE
InventorsAnn-Katrin Kieninger, Lorenzo Corsini, Lenka Podpera Tisakova, Timo Schwebs, Maria Protano, Albina Poljak
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Abstract
The present invention relates to new pharmaceutical compositions comprising an effective amount of an active agent and a pharmaceutical acceptable excipient, wherein said active agent is a polypeptide having a killing activity against Gardnerella and wherein said excipient is a polyacrylic acid polymer. The present invention further relates to uses of the pharmaceutical compositions in the treatment of Gardnerella infections, in particular bacterial vaginosis.
Claims22
A pharmaceutical composition comprising an effective amount of an active agent and a pharmaceutical acceptable excipient, wherein said active agent is a polypeptide having a killing activity against Gardnerella and wherein said excipient is a polyacrylic acid polymer.
The pharmaceutical composition according to any one of the preceding claims, wherein said polypeptide is a polypeptide having at least 80% sequence identity with the amino acid sequence as provided in SEQ ID NO:
- 1 or SEQ ID NO:37 and having a killing activity against Gardnerella.
The pharmaceutical composition according to any one of the preceding claims, wherein said polypeptide is a recombinant endolysin comprising the amino acid sequence provided in SEQ ID NO:
- 1 or SEQ ID NO:
- 37.
The pharmaceutical composition according to any one of the preceding claims, wherein said polypeptide has a killing activity against Gardnerella vaginalis sensu stricto, Gardnerella leopoldii, Gardnerella piotii and/or Gardnerella swidsinskii, or any other species in the genus Gardnerella.
The pharmaceutical composition according to any one of the preceding claims, wherein said polypeptide has a killing activity against Lactobacillus iners.
The pharmaceutical composition according to any one of the preceding claims, wherein said polypeptide has no killing activity against Lactobacilli crispatus, Lactobacilli gasseri, and/or Lactobacilli jensenii.
The pharmaceutical composition according to any one of the preceding claims, wherein said excipient is present at a concentration of about 0.01% and 10%, preferably about 0.1% to 1%, more preferably about 0.2% to 0.5%, most preferably about 0.25% or about 0.35%.
The pharmaceutical composition according to any one of the preceding claims, wherein the polyacrylic acid polymer is a crosslinked polyacrylic acid polymer or a carbomer.
The pharmaceutical composition according to any one of the preceding claims, wherein the combination of said active agent with said excipient increases the pharmaceutical activity of said active agent.
The pharmaceutical composition according to any one of the preceding claims, wherein the composition further comprises a salt.
The pharmaceutical composition according to any one of the preceding claims, wherein said composition is suitable for intra-vaginal delivery of the active agent.
The pharmaceutical composition according to any one of the preceding claims, for use in treating a bacterial infection in a subject, preferably wherein the bacterial infection is bacterial vaginosis.
Dependencies are inferred from the claim text.