IP Library › Granted Patent US 12,558,372
Granted Patent B2
US 12,558,372 · App. 17/263,327 · Granted Feb 24, 2026

Polyhydroxyalkanoates for use in the prevention or treatment of an overweight or obesity condition, or of metabolic dysfunctions related to said condition

Inventors: Maria Pina Mollica (Naples, IT); Paolo Saettone (San Giorgio di Piano, IT); Giovanna Trinchese (Naples, IT); Gina Cavaliere (Naples, IT); Giuseppina Mattace Raso (Naples, IT); Mauro Comes Franchini (San Giorgio di Piano, IT)
Assignee: BIO ON S.P.A.
A61K31/765A61K9/0053A61P3/04C08G63/06
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,558,372
App. No.
17/263,327
Granted
Feb 24, 2026
Kind
B2
Abstract

A polyhydroxyalkanoate (PHA) containing monomer units of 3-hydroxybutyrate for use, by oral administration, in the prevention or treatment of an overweight or obesity condition, or of metabolic dysfunctions related to the condition. A marked effect was observed on the reduction of the body weight, both in the case of a standard diet and in the case of a diet rich in fats, a reduction that can be attributed to an increase in lipid oxidation to the detriment of the deposit of excess lipids, as confirmed by the decrease in the body weight and by analyses of the body composition. A positive effect on the metabolic dysfunctions related to an overweight or obesity condition has also been verified, in particular on dyslipidemias, such as the blood level of low-density lipoproteins (LDL cholesterol) and triglycerides, as well as an improvement in the inflammatory state.

Claims (8)

1 . A method for reducing fat accumulation in a mammal, the method comprising oral administration to the mammal of poly-3-hydroxybutyrate (P3HB), wherein the P3HB has a weight average molecular weight (M w ) in the range from 100,000 to 1,500,000 Da, as determined by Gel Permeation Chromatography.

2 . The method according to claim 1 , wherein the P3HB has a weight average molecular weight (M w ) in the range from 100,000 to 1,000,000 Da.

3 . The method according to claim 1 , wherein the oral administration is an administration of an aqueous suspension of the PH3B to a mammal affected by obesity.

4 . The method according to claim 1 , wherein the oral administration is a food administration.

5 . The method according to claim 1 , wherein the oral administration has a daily dosage equal to or higher than 0.3 g/kg body weight.

6 . The method according to claim 1 , wherein the oral administration has a daily dosage equal to or lower than 2.5 g/kg body weight.

7 . The method according to claim 5 , wherein the oral administration has a daily dosage equal to or higher than 0.4 g/kg body weight.

8 . The method according to claim 6 , wherein the oral administration has a daily dosage equal to or lower than 1.5 g/kg body weight.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 27, 2023
From: BIO-ON S.P.A.
To: BIO ON S.P.A.
Reel/Frame 065668/0744 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 26, 2021
From: MOLLICA, MARIA PINA; SAETTONE, PAOLO; TRINCHESE, GIOVANNA; CAVALIERE, GINA; MATTACE RASO, GIUSEPPINA; COMES FRANCHINI, MAURO
To: BIO-ON S.P.A.
Reel/Frame 055118/0375 →
Priority Claims (1)
IT 102018000007524 · Jul 26, 2018 · national
Continuity (1)
Related Publication 20210161948A1 · Jun 3, 2021
References Cited (21)
EP 1098655A2 · 2001 [cited by applicant]
WO 9841200A1 · 1998 [cited by applicant]
WO WO9932536A1 · 1999 [cited by examiner]
WO 0004895A2 · 2000 [cited by applicant]
WO WO2014106026A1 · 2014 [cited by examiner]
Sigma-Aldrich https://www.sigmaaldrich.com/specification-sheets/146/356/403105-BULK______ALDRICH__.pdf(accessed Jun. 13, 2024). (Year: 2024). [cited by examiner]
Peirson, L. et al. Treatment for overweight and obesity in adult populations: a systematic review and meta-analysis, CMAJ Open, 2014.DOI:10.9778/cmajo.20140012 (Year: 2014). [cited by examiner]
Jones et al., The New Era of Drug Therapy for Obesity: The Evidence and the Expectations, Drugs (215) 75:935-945 2015 (Year: 2015). [cited by examiner]
Rivera-Briso et al. Poly(3-Hydroxybutyrate-co-3-Hydroxyvalerate): Enhancement Strategies for Advanced Applications, Polymers 2018, 10, 732; doi: 10.3390/polym10070732. (Year: 2018). [cited by examiner]
Fischer et al., “Effect of a Sodium and Calcium DL-β-Hydroxybutyrate Salt in Healthy Adults”, Journal of Nutrition and Metabolism, vol. 2018, pp. 1-8. [cited by applicant]
A Hernandez-Aguilera et al., “Mitochondrial dysfunction: a basic mechanism in inflammation-related non-communicable diseases and therapeutic opportunities”, Mediators Inflamm, 2013. [cited by applicant]
A. Lama et al., “Polyphenol-rich virgin olive oil reduces insulin resistance and liver inflammation and improves mitochondrial dysfunction in high-fat diet fed rats”, Mol Nutr Food Res, Mar. 2017, vol. 61, No. 3, Epub D… [cited by applicant]
C.K. Chakraborti, “Role of adiponectin and some other factors linking type 2 diabetes mellitus and obesity”; World J. Diabetes, 2015, vol. 6, pp. 1296-1308. [cited by applicant]
Dr. Simon F. Williams et al. “Applications of PHAs in Medicine and Pharmacy”, Biopolyymers—Polyesters III: Applications and Commerical Products, Jan. 15, 2005, vol. 4, pp. 1-38, XP002789682. [cited by applicant]
G.L.S. Pawan et al. “Effect Of 3-Hydroxybutyrate in Obese Subjects On Very-Low-Energy Diets and During Therapeutic Starvation”, Jan. 31, 1993, the whole document, [retrieved on Nov. 20, 2018] Retrieved from the Internet… [cited by applicant]
International Search Report issued Nov. 21, 2019 re: Application No. PCT/IB2019/056309, pp. 1-4, citing: EP 1 098 655 A2, Dr. Williams et al. “Applications of PHAs . . . ”, Greaves MF et al. “Effect of . . . ”. [cited by applicant]
M.P. Mollica et al., “Butyrate Regulates Liver Mitochondrial Function, Efficiency, and Dynamics in Insulin-Resistant Obese Mice”, Diabetes, May 2017, vol. 66, No. 5, pp. 1405-1418. [cited by applicant]
T. Yamauchi et al., “Adiponectin stimulates glucose utilization and fatty-acid oxidation by activating AMP-activated protein kinase”, Nat. Med., 2002, vol. 8, pp. 1288-1295. [cited by applicant]
World Health Organization (WHO), “Obesity and Overweight”, Feb. 16, 2018, whole document, available on http://www.who.int/news-room/fact-sheets/detail/ obesity-and-overweight. [cited by applicant]
Written Opinion issued Nov. 21, 2019 re: Application No. PCT/IB2019/056309, pp. 1-6, citing: EP 1 098 655 A2, Dr. Williams et al. “Applications of PHAs . . . ”, Greaves MF et al. “Effect of . . . ”. [cited by applicant]
Y. Minokoshi et al., “Leptin stimulates fatty-acid oxidation by activating AMP-activated protein kinase”, Nature, 2002, vol. 415, pp. 339-343. [cited by applicant]