Claims for Patent: 12,544,337

Summary for Patent: 12,544,337

Title:	Combinations of beta-lactam compounds and probenecid and uses thereof
Abstract:	The present disclosure relates to bilayer tablets comprising a second layer comprising a β-lactam compound or a pharmaceutically acceptable salt thereof; and a first layer comprising probenecid or a pharmaceutically acceptable salt thereof. The present disclosure also relates to methods of treating or preventing a disease using the bilayer tablets.
Inventor(s):	Michael Dunne, Tom LOUGHMAN, Aaron CAMERON
Assignee:	Iterum Therapeutics International Ltd
Application Number:	US17/948,790
Patent Claims:	1. A bilayer tablet, comprising: a first layer comprising from 450 mg to 550 mg of probenecid or a pharmaceutically acceptable salt thereof, and a second layer comprising from 450 mg to 550 mg of: 2. The bilayer tablet of claim 1, wherein: the first layer comprises about 500 mg of probenecid or a pharmaceutically acceptable salt thereof; and the second layer comprises about 500 mg of Compound III-2. 3. The bilayer tablet of claim 1, wherein the first layer of the bilayer tablet comprises about 500 mg of probenecid. 4. The bilayer tablet of claim 1, wherein the second layer comprises Compound III-2b. 5. The bilayer tablet of claim 1, wherein the second layer of the bilayer tablet comprises about 500 mg of Compound III-2. 6. The bilayer tablet of claim 1, further comprising one or more pharmaceutical excipients selected from a binder, a disintegrating agent, a lubricant, a glidant, a sweetening agent, and a flavoring agent. 7. The bilayer tablet of claim 1, further comprising cellulose, sodium croscarmellose, magnesium stearate, lactose monohydrate, and hydroxypropylcellulose. 8. The bilayer tablet of claim 1, wherein: the first layer comprises about 500 mg of probenecid; and the second layer comprises about 500 mg of Compound III-2b. 9. A method of preparing the bilayer tablet of claim 1, comprising: i) compressing a first granular material comprising probenecid or a pharmaceutically acceptable salt thereof with a first force, thereby forming a pre-compressed first layer; ii) adding a second granular material comprising Compound III-2 to the pre-compressed first layer; and iii) compressing the pre-compressed first layer and the second granular material with a second force, thereby forming a pre-coated bilayer tablet. 10. A method of treating or preventing a disease, comprising administering to a subject in need thereof a therapeutically effective amount of the bilayer tablet of claim 1. 11. The method of claim 10, wherein the subject in need thereof is a human. 12. The method of claim 10, wherein the disease is associated with an increased or decreased population of one or more bacteria selected from Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae, Klebsiella oxytoca, Citrobacter freundii complex, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus species, Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides uniformis, Porphyromonas asaccharolytica, Prevotella bivia, Staphylococcus epidermidis, Streptococcus pneumonia, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pyogenes, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Haemophilus influenza, Haemophilus parainfluenzae, Klebsiella oxytoca, Moraxella catarrhalis, Morganella morganii, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens Bacteroides vulgatus, Clostridium perfringens, and Fusobacterium spp. 13. The method of claim 10, wherein the disease is associated with an infection, wherein the infection is an uncomplicated urinary tract infection, a complicated urinary tract infection, a complicated intra-abdominal infection, pneumonia, otitis media, sinusitis, gonococcal urethritis, pelvic inflammatory disease, prostatitis, bone infection, joint infection, diabetic foot infection, and infectious diarrhea. 14. The method of claim 10, wherein the disease is a neurodegenerative disease, amyotrophic lateral sclerosis, Parkinson's disease, Alzheimer's disease, or Huntington's disease, cancer, or an inflammatory bowel disease. 15. The method of claim 10, wherein the bilayer tablet is administered to the subject with food. 16. The method of claim 10, wherein the administration results in a plasma concentration for Compound III-2 having an area under the curve (AUC) that is higher in the subject in need thereof as compared to a comparable subject being administered with a comparable composition. 17. The method of claim 10, wherein the administration results in a maximum plasma concentration (Cmax) in the subject in need thereof that substantially the same as compared to a comparable subject being administered with a comparable composition.