WO2020128967A3 - Efinopegdutide for use in the treatment of severe non-diabetic obesity - Google Patents

Efinopegdutide for use in the treatment of severe non-diabetic obesity Download PDF

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Publication number
WO2020128967A3
WO2020128967A3 PCT/IB2019/061125 IB2019061125W WO2020128967A3 WO 2020128967 A3 WO2020128967 A3 WO 2020128967A3 IB 2019061125 W IB2019061125 W IB 2019061125W WO 2020128967 A3 WO2020128967 A3 WO 2020128967A3
Authority
WO
WIPO (PCT)
Prior art keywords
oxyntomodulin derivative
efinopegdutide
treatment
severe non
diabetic obesity
Prior art date
Application number
PCT/IB2019/061125
Other languages
French (fr)
Other versions
WO2020128967A2 (en
Inventor
Mahesh N. Samtani
Gary E. Meininger
Penny R. 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 WO2020128967A2 publication Critical patent/WO2020128967A2/en
Publication of WO2020128967A3 publication Critical patent/WO2020128967A3/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
    • A61K47/68—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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • 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)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Child & Adolescent Psychology (AREA)
  • Endocrinology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Abstract

Disclosed herein are methods of treating severe non-diabetic obesity with a fixed dose or multiple ascending dose of an oxyntomodulin derivative conjugate, wherein 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/IB2019/061125 2018-12-19 2019-12-19 Methods of treating severe non-diabetic obesity WO2020128967A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862782035P 2018-12-19 2018-12-19
US62/782,035 2018-12-19

Publications (2)

Publication Number Publication Date
WO2020128967A2 WO2020128967A2 (en) 2020-06-25
WO2020128967A3 true WO2020128967A3 (en) 2020-07-30

Family

ID=69167868

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2019/061125 WO2020128967A2 (en) 2018-12-19 2019-12-19 Methods of treating severe non-diabetic obesity

Country Status (1)

Country Link
WO (1) WO2020128967A2 (en)

Citations (5)

* 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
WO2019171352A2 (en) * 2018-03-08 2019-09-12 Janssen Pharmaceutica Nv Methods of treating severe non-diabetic obesity

Patent Citations (5)

* 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
WO2019171352A2 (en) * 2018-03-08 2019-09-12 Janssen Pharmaceutica Nv Methods of treating severe non-diabetic obesity

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: "Efinopegdutide", REGISTRY, CHEMICAL ABSTRACTS SERVICE, COLUMBUS, OHIO, US, 8 January 2017 (2017-01-08), XP002793492 *
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] *
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: "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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