Composition for the treatment of muscle wasting

Patent metadata

Field	Value
Publication number	US-12521359-B2
Application number	US-202017619733-A
Country	US
Kind code	B2
Filing date	Jun 29, 2020
Priority date	Jun 28, 2019
Publication date	Jan 13, 2026
Grant date	Jan 13, 2026

Abstract

The present invention relates to compositions comprising branched-chain amino acids (BCAA) and the amino acid L-Alanine and their use in the prevention and/or treatment of muscle wasting associated to pathological or age-related conditions.

First claim

The invention claimed is:

1 . A method of preventing, ameliorating and/or treating muscle wasting associated with:
i) pathological conditions; ii) age-related conditions; or iii) malnutrition, immobility or fasting,
in a subject in need of such prevention, amelioration, and/or treatment, comprising administration of an amount of a composition comprising branched-chain amino acids (BCAAs) L-Leucine, L-Valine and L-Isoleucine in combination with L-Alanine, wherein L-Leucine, L-Valine, L-Isoleucine and L-Alanine are the only pharmaceutically active amino acids present in the composition, which composition is effective for preventing, ameliorating and/or treating muscle wasting associated with pathological conditions; age-related conditions; or malnutrition, immobility or fasting.

2 . The method according to claim 1 , wherein the muscle wasting is associated with a pathological condition selected from the group consisting of neuromuscular degenerative disorders, including muscular dystrophy and muscular atrophy; chronic obstructive pulmonary disorder; cancer-associated cachexia; diabetes; renal failure; cardiac failure; Cushing Syndrome; sepsis; burn injuries; uremia; cirrhosis; and AIDS.

3 . The method according to claim 1 , wherein the muscle wasting is associated with the age-related condition sarcopenia.

4 . The method according to claim 1 , wherein L-Leucine, L-Valine and L-Isoleucine are present in the composition in a weight ratio between 2:1:1 and 8:1:1.

5 . The method according to claim 1 , wherein L-Leucine, L-Valine and L-Isoleucine are present in the composition in a weight ratio of 2:1:1 or 4:1:1 or 8:1:1.

6 . The method according to claim 1 , wherein the weight ratio L-Leucine:L-Valine:L-Isoleucine:L-Alanine is 2:1:1:2.

7 . The method according to claim 1 , wherein the composition is a pharmaceutical composition.

8 . The method according to claim 1 , wherein the composition is a dietary supplement.

9 . The method according to claim 1 , wherein the composition is administered orally.

10 . The method according to claim 1 , wherein the composition contains per unit dose: between 0.6 and 1 g of L-Leucine, between 0.3 and 0.5 g of L-Isoleucine, between 0.3 and 0.5 g of L-Valine and from 0.4 g to 1.2 g of L-Alanine.

11 . The method according to claim 10 , wherein the composition contains per unit dose: 0.8 g of L-Leucine, 0.4 g of L-Isoleucine, 0.4 g of L-Valine and 0.8 g of L-Alanine.

12 . The method according to claim 10 , wherein the unit dose is administered twice a day.

Assignees

• Dompe Farm Spa

Inventors

• Allegretti Marcello
• Aramini Andrea
• Bianchini Gianluca

Classifications

• A61P21/00 Primary

  Drugs for disorders of the muscular or neuromuscular system · CPC title

• A61K2300/00

  Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00 · CPC title

• A61K38/05

  Dipeptides · CPC title

• A61K31/198 Primary

  Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00) · CPC title