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WO2021263040A8 - Stable peptibody formulations - Google Patents

Stable peptibody formulations Download PDF

Info

Publication number
WO2021263040A8
WO2021263040A8 PCT/US2021/038976 US2021038976W WO2021263040A8 WO 2021263040 A8 WO2021263040 A8 WO 2021263040A8 US 2021038976 W US2021038976 W US 2021038976W WO 2021263040 A8 WO2021263040 A8 WO 2021263040A8
Authority
WO
WIPO (PCT)
Prior art keywords
formulations
peptibody
stable
pth
glp
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2021/038976
Other languages
French (fr)
Other versions
WO2021263040A1 (en
Inventor
Christian Fiedler
Michael Graninger
Dominik MITTERGRADNEGGER
Tanvir TABISH
Joris Hoefinghoff
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shire NPS Pharmaceuticals Inc
Original Assignee
Shire NPS Pharmaceuticals Inc
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 Shire NPS Pharmaceuticals Inc filed Critical Shire NPS Pharmaceuticals Inc
Publication of WO2021263040A1 publication Critical patent/WO2021263040A1/en
Publication of WO2021263040A8 publication Critical patent/WO2021263040A8/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • A61K38/29—Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

The present invention is directed to formulations comprising GLP-2 or PTH, or specified portions or variants thereof, fused with immunoglobulin or derivatives thereof. The formulations may comprise a GLP-2 or a PTH peptibody, a carrier, a buffer, at least one amino acid, and at least one excipient. The formulations have a pH from about 5 to about 8. The invention is further directed to methods of making, storing, and using the peptibody formulations and, still further, to kits comprising said formulations.
PCT/US2021/038976 2020-06-26 2021-06-24 Stable peptibody formulations Ceased WO2021263040A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063044877P 2020-06-26 2020-06-26
US63/044,877 2020-06-26

Publications (2)

Publication Number Publication Date
WO2021263040A1 WO2021263040A1 (en) 2021-12-30
WO2021263040A8 true WO2021263040A8 (en) 2022-08-04

Family

ID=79281866

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2021/038976 Ceased WO2021263040A1 (en) 2020-06-26 2021-06-24 Stable peptibody formulations

Country Status (1)

Country Link
WO (1) WO2021263040A1 (en)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001012786A1 (en) * 1999-08-16 2001-02-22 Human Genome Sciences, Inc. Retinoid receptor interacting polynucleotides, polypeptides, and antibodies
BR112018017091A2 (en) * 2016-03-01 2019-01-02 Ascendis Pharma Bone Diseases As pth prodrugs
JP7249492B2 (en) * 2017-08-22 2023-03-31 タケダ ファーマシューティカルズ ユーエスエー インコーポレイテッド GLP-2 fusion polypeptides and their use for treating and preventing gastrointestinal conditions
KR102825098B1 (en) * 2017-11-06 2025-06-26 다케다 야쿠힌 고교 가부시키가이샤 GLP-2 analogues and peptibodies for preoperative, intraoperative, or postoperative administration

Also Published As

Publication number Publication date
WO2021263040A1 (en) 2021-12-30

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