Claims for Patent: 11,878,011

Summary for Patent: 11,878,011

Title:	Method for eradicating Helicobacter pylori infection in patients regardless of body mass index
Abstract:	A method of treating patients who are positive for Helicobacter pylori infection comprises determining that a first patient who is positive for Helicobacter pylori infection has a body mass index corresponding to normal weight or overweight; determining that a second patient who is positive for Helicobacter pylori infection has a body mass index corresponding to obese or extremely obese; and administering to both the first patient and the second patient, for 14 days, a rifabutin-based triple therapy consisting essentially of rifabutin, amoxicillin and omeprazole or an equivalent amount of a pharmaceutically acceptable salt thereof, wherein, after treatment is complete, there is no substantial difference in the efficacy of the treatment when the treatment is administered to the first patient or the second patient.
Inventor(s):	Reza Fathi, Kely Lee Sheldon
Assignee:	Redhill Biopharma Ltd
Application Number:	US16/869,199
Patent Claims:	1. A method of treating patients who are positive for Helicobacter pylori infection comprising: determining that a first patient who is positive for Helicobacter pylori infection has a body mass index corresponding to normal weight or overweight; determining that a second patient who is positive for Helicobacter pylori infection has a body mass index corresponding to obese or extremely obese; and administering to both the first patient and the second patient, for 14 days, a rifabutin-based triple therapy consisting essentially of rifabutin, amoxicillin and omeprazole or an equivalent amount of a pharmaceutically acceptable salt thereof, wherein, after treatment is complete, there is no substantial difference in the efficacy of the treatment when the treatment is administered to the first patient or the second patient wherein the rifabutin-based triple therapy comprises a plurality of fixed-dose combination formulations which provide a total daily dose of 150 mg rifabutin, 3,000 mg amoxicillin, and 120 mg omeprazole or an equivalent amount of a pharmaceutically acceptable salt thereof, and wherein each fixed-dose combination formulation comprises between 36 and 40 immediate release minitablets, the immediate release minitablets comprising both amoxicillin and rifabutin, and between 32 and 36 enteric-coated omeprazole minitablets. 2. The method of claim 1, wherein the first patient has a BMI ranging from 18.50 kg/m2 to 24.99 kg/m2 and the second patient has a BMI ranging from 30.0 kg/m2 to 34.99 kg/m2. 3. The method of claim 1, wherein the first patient has a BMI ranging from 18.50 kg/m2 to 24.99 kg/m2 and the second patient has a BMI ranging from 35.0 kg/m2 to 39.99 kg/m2. 4. The method of claim 1, wherein the first patient has a BMI ranging from 18.50 kg/m2 to 24.99 kg/m2 and the second patient has a BMI above 40.00 kg/m2. 5. The method of claim 1, wherein the first patient has a BMI ranging from 25.00 kg/m2 to 29.99 kg/m2 and the second patient has a BMI ranging from 35.0 kg/m2 to 39.99 kg/m2. 6. The method of claim 1, wherein the first patient has a BMI 25.00 kg/m2 to 29.99 kg/m2 and the second patient has a BMI ranging from 30.0 kg/m2 to 34.99 kg/m2. 7. The method of claim 1, wherein the first patient has a BMI 25.00 kg/m2 to 29.99 kg/m2 and the second patient has a BMI above 40.00 kg/m2. 8. The method of claim 1, wherein each fixed-dose combination formulation comprises 12.5 mg rifabutin, 250 mg amoxicillin and 10 mg omeprazole or an equivalent amount of a pharmaceutically acceptable salt thereof. 9. The method of claim 1, wherein each fixed-dose combination formulation comprises the immediate release minitablets and the enteric coated omeprazole minitablets are in a capsule. 10. The method of claim 1, wherein each immediate release minitablet and each enteric-coated omeprazole minitablet are about 2 mm in size. 11. The method of claim 1, wherein each fixed-dose combination formulation comprises 38 immediate release minitablets, the immediate release minitablets comprising both amoxicillin and rifabutin and 34 enteric-coated omeprazole minitablets. 12. The method of claim 1, wherein at least 70% by weight of the omeprazole is intestinally released after oral administration. 13. The method of claim 1, wherein the amoxicillin is amoxicillin trihydrate. 14. The method of claim 1, wherein the omeprazole is omeprazole magnesium. 15. The method of claim 1, further comprising confirming H. pylori eradication with a negative 13C UBT or fecal antigen test performed ≥28 days post-therapy. 16. The method of claim 1, wherein the second patient who tested positive for Helicobacter pylori infection is obese with a BMI above 30.00 kg/m2 and is preparing for bariatric surgery.