WO2019171352A3 - Methods of treating severe non-diabetic obesity - Google Patents

Methods of treating severe non-diabetic obesity Download PDF

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Publication number
WO2019171352A3
WO2019171352A3 PCT/IB2019/051915 IB2019051915W WO2019171352A3 WO 2019171352 A3 WO2019171352 A3 WO 2019171352A3 IB 2019051915 W IB2019051915 W IB 2019051915W WO 2019171352 A3 WO2019171352 A3 WO 2019171352A3
Authority
WO
WIPO (PCT)
Prior art keywords
methods
oxyntomodulin derivative
treating severe
severe non
diabetic obesity
Prior art date
Application number
PCT/IB2019/051915
Other languages
French (fr)
Other versions
WO2019171352A2 (en
Inventor
Mahesh N. Samtani
Gary MEININGER
Penny Renee FLECK
Maria ALBA
Original Assignee
Janssen Pharmaceutica Nv
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Janssen Pharmaceutica Nv filed Critical Janssen Pharmaceutica Nv
Publication of WO2019171352A2 publication Critical patent/WO2019171352A2/en
Publication of WO2019171352A3 publication Critical patent/WO2019171352A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Endocrinology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Disclosed herein are methods of treating severe non-diabetic obesity with an oxyntomodulin derivative conjugate administered once weekly at a dose of about 5 mg to about 10 mg. The oxyntomodulin derivative conjugate comprises an oxyntomodulin derivative comprising the amino acid sequence of SEQ ID NO: 2 and having a ring formation between residues 16 and 20; an IgG4 Fc region; and a polyethylene glycol, wherein the polyethylene glycol covalently links the oxyntomodulin derivative and the IgG4 Fc region.
PCT/IB2019/051915 2018-03-08 2019-03-08 Methods of treating severe non-diabetic obesity WO2019171352A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862640463P 2018-03-08 2018-03-08
US62/640,463 2018-03-08

Publications (2)

Publication Number Publication Date
WO2019171352A2 WO2019171352A2 (en) 2019-09-12
WO2019171352A3 true WO2019171352A3 (en) 2019-11-07

Family

ID=66223762

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2019/051915 WO2019171352A2 (en) 2018-03-08 2019-03-08 Methods of treating severe non-diabetic obesity

Country Status (1)

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WO (1) WO2019171352A2 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY164680A (en) 2011-06-17 2018-01-30 Hanmi Science Co Ltd A conjugate comprising oxyntomodulin and an immunoglobulin fragment, and use thereof
AU2013342321B2 (en) 2012-11-06 2017-09-28 Hanmi Pharm. Co., Ltd. Liquid formulation of protein conjugate comprising the oxyntomodulin and an immunoglobulin fragment
KR102418477B1 (en) 2014-12-30 2022-07-08 한미약품 주식회사 Gluagon Derivatives
WO2020128967A2 (en) * 2018-12-19 2020-06-25 Janssen Pharmaceutica Nv Methods of treating severe non-diabetic obesity

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012173422A1 (en) * 2011-06-17 2012-12-20 Hanmi Science Co., Ltd. A conjugate comprising oxyntomodulin and an immunoglobulin fragment, and use thereof
WO2014017843A1 (en) * 2012-07-25 2014-01-30 Hanmi Pharm. Co., Ltd. Composition for treating hyperlipidemia comprising oxyntomodulin derivative
WO2014073845A1 (en) * 2012-11-06 2014-05-15 Hanmi Pharm. Co., Ltd. A composition for treating diabetes or diabesity comprising oxyntomodulin analog
WO2016043533A1 (en) * 2014-09-16 2016-03-24 Hanmi Pharm. Co., Ltd. Use of a long acting glp-1/glucagon receptor dual agonist for the treatment of non-alcoholic fatty liver disease

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012173422A1 (en) * 2011-06-17 2012-12-20 Hanmi Science Co., Ltd. A conjugate comprising oxyntomodulin and an immunoglobulin fragment, and use thereof
WO2014017843A1 (en) * 2012-07-25 2014-01-30 Hanmi Pharm. Co., Ltd. Composition for treating hyperlipidemia comprising oxyntomodulin derivative
WO2014073845A1 (en) * 2012-11-06 2014-05-15 Hanmi Pharm. Co., Ltd. A composition for treating diabetes or diabesity comprising oxyntomodulin analog
WO2016043533A1 (en) * 2014-09-16 2016-03-24 Hanmi Pharm. Co., Ltd. Use of a long acting glp-1/glucagon receptor dual agonist for the treatment of non-alcoholic fatty liver disease

Non-Patent Citations (11)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "2017-003616-39: A Randomized, Double-blind Placebo-controlled and Open-label Active-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Subjects", 13 March 2018 (2018-03-13), pages 1 - 5, XP055612057, Retrieved from the Internet <URL:https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003616-39/SE> [retrieved on 20190809] *
ANONYMOUS: "Disposicion N° 05458", 17 July 2017 (2017-07-17), pages 1 - 8, XP055612052, Retrieved from the Internet <URL:http://www.anmat.gov.ar/boletin_anmat/mayo_2017/Dispo_5458-17.pdf> [retrieved on 20190809] *
ANONYMOUS: "HM 12525A - AdisInsight", 14 October 2017 (2017-10-14), pages 1 - 4, XP055612030, Retrieved from the Internet <URL:http://web.archive.org/web/20171014193308/https://adisinsight.springer.com/drugs/800040692> [retrieved on 20190809] *
ANONYMOUS: "International Nonproprietary Names for Pharmaceutical Substances (INN)", WHO DRUG INFORMATION, vol. 31, no. 4, 19 January 2017 (2017-01-19), pages 635 - 754, XP055612042 *
ANONYMOUS: "NCT03486392: A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants", 30 March 2018 (2018-03-30), pages 1 - 9, XP055612060, Retrieved from the Internet <URL:https://clinicaltrials.gov/ct2/history/NCT03486392?V_1=View#StudyPageTop> [retrieved on 20190809] *
DATABASE REGISTRY [online] CHEMICAL ABSTRACTS SERVICE, COLUMBUS, OHIO, US; 8 January 2017 (2017-01-08), ANONYMOUS: "Efinopegdutide", XP002793492, retrieved from STN Database accession no. 2055640-93-0 *
J KANG ET AL: "791: The ultra-long acting LAPSGLP/GCGdual agonist,HM12525A, demonstrated safety and prolonged pharmacokinetics in healthy volunteers: a phase 1 first-in-human study", ABSTRACTS OF 51ST EASD ANNUAL MEETING, vol. 58, 1 September 2015 (2015-09-01), pages S380 - S381, XP055611972 *
JAHOON KANG ET AL: "The ultra-long acting LAPS GLP/GCG dual agonist, HM12525A, demonstrated safety and prolonged pharmacokinetics in healthy volunteers: a phase 1 first-in-human study PS-069-791 REFERENCES", 23 September 2015 (2015-09-23), pages 1 - 2, XP055612020, Retrieved from the Internet <URL:http://www.hanmipharm.com/ehanmi/img/rnd/2015_EASD_(HM12525A).pdf> [retrieved on 20190809] *
JI-HEE HA ET AL: "Immunoglobulin Fc Heterodimer Platform Technology: From Design to Applications in Therapeutic Antibodies and Proteins", FRONTIERS IN IMMUNOLOGY, vol. 7, 6 October 2016 (2016-10-06), pages 1 - 16, XP055377975, DOI: 10.3389/fimmu.2016.00394 *
S JUNG ET AL: "790: Potent weight loss mechanism and improvement of NASH by the long-acting GLP-1/glucagon receptor dual agonist HM12525A", ABSTRACTS OF 51ST EASD ANNUAL MEETING, vol. 58, 1 September 2015 (2015-09-01), pages S380 - S381, XP055611969, DOI: 10.1007/s00125-015-3687-4 *
SY JUNG ET AL: "A Novel Long-Acting GLP-1/Glucagon Dual Receptor Agonist: Potent Weight Loss Mechanism and Improvement of NASH by HM12525A", 75TH ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION, 6 June 2015 (2015-06-06), pages 1, XP055611892 *

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