Claims for Patent: 11,135,192

Summary for Patent: 11,135,192

Title:	Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Abstract:	The present invention relates to the NEP inhibitor pro-drug N-(3-carboxy-1-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylb- utanoic acid ethyl ester, or a pharmaceutically acceptable salt thereof; or the NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylb- utanoic acid, or a pharmaceutically acceptable salt thereof, pro-drug for use in the treatment, prevention or delay of progression of a disease characterized by atrial enlargement and/or remodeling; a method for treatment, prevention or delay of progression of a disease characterized by atrial enlargement and/or remodeling comprising administration of a therapeutically effective amount, or a prophylactically effective amount, of the NEP inhibitor or the NEP inhibitor pro-drug, or a pharmaceutically acceptable salt pro-drug thereof, to a subject, e.g. a human subject, in need of such treatment. The present invention further relates to a pharmaceutical composition or a commercial package comprising the NEP inhibitor or the NEP inhibitor pro-drug, or a pharmaceutically acceptable salt thereof, pro-drug for use in the treatment, prevention or delay of progression of a disease characterized by atrial enlargement and/or remodeling.
Inventor(s):	Schumacher; Christoph (Bettingen, CH), Holbro; Thomas (Basel, CH)
Assignee:	Novartis AG (Basel, CH)
Application Number:	15/912,701
Patent Claims:	1. A method for treating heart failure with preserved ejection fraction (HF-PEF) in a human patient in need of such treatment, the method comprising administering to the patient 50 mg, 100 mg, or 200 mg of a combination of: (i) N-(3-carboxy-1-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylb- utanoic acid ethyl ester or a pharmaceutically acceptable salt thereof; and (ii) valsartan or a pharmaceutically acceptable salt thereof, twice daily for at least 36 weeks, wherein N-(3-carboxy-1-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylb- utanoic acid ethyl ester or the pharmaceutically acceptable salt thereof and valsartan or the pharmaceutically acceptable salt thereof are administered in a 1:1 molar ratio, and wherein the patient's left atrial volume, left atrial volume index (LAVI) and/or left atrial dimension are/is reduced. 2. The method according to claim 1, wherein the patient's plasma NT-proBNP concentration is reduced. 3. The method according to claim 1, wherein the patient's NYHA classification is improved, stabilized, or delayed in worsening. 4. A method for treating heart failure with preserved ejection fraction (HF-PEF) in a human patient in need of such treatment, the method comprising administering to the patient 50 mg, 100 mg, or 200 mg of a combination of: (i) N-(3-carboxy-1-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylb- utanoic acid ethyl ester or a pharmaceutically acceptable salt thereof; and (ii) valsartan or a pharmaceutically acceptable salt thereof, twice daily for at least 36 weeks, wherein N-(3-carboxy-1-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylb- utanoic acid ethyl ester or the pharmaceutically acceptable salt thereof and valsartan or the pharmaceutically acceptable salt thereof are administered in a 1:1 molar ratio. 5. The method according to claim 4, wherein the patient's plasma NT-proBNP concentration is reduced. 6. The method according to claim 4, wherein the patient's NYHA classification is improved, stabilized, or delayed in worsening.