AU2021364523A1 - Compositions suitable for use in neonates - Google Patents

Compositions suitable for use in neonates Download PDF

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Publication number
AU2021364523A1
AU2021364523A1 AU2021364523A AU2021364523A AU2021364523A1 AU 2021364523 A1 AU2021364523 A1 AU 2021364523A1 AU 2021364523 A AU2021364523 A AU 2021364523A AU 2021364523 A AU2021364523 A AU 2021364523A AU 2021364523 A1 AU2021364523 A1 AU 2021364523A1
Authority
AU
Australia
Prior art keywords
weeks
composition
months
igf
polysorbate
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.)
Pending
Application number
AU2021364523A
Other languages
English (en)
Inventor
Benita AMSDEN
Indranil Bhattacharya
Linda HAN
Bing He
James KRANZ
Nazila Salamat-Miller
Katherine Taylor
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.)
Oak Hill Bio Ltd
Original Assignee
Oak Hill Bio Ltd
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 Oak Hill Bio Ltd filed Critical Oak Hill Bio Ltd
Publication of AU2021364523A1 publication Critical patent/AU2021364523A1/en
Pending legal-status Critical Current

Links

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
    • A61K38/30—Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
    • 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
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • A61K38/1754—Insulin-like growth factor binding proteins
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurosurgery (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Cardiology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
AU2021364523A 2020-10-19 2021-10-19 Compositions suitable for use in neonates Pending AU2021364523A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063093696P 2020-10-19 2020-10-19
US63/093,696 2020-10-19
PCT/US2021/055598 WO2022086953A1 (en) 2020-10-19 2021-10-19 Compositions suitable for use in neonates

Publications (1)

Publication Number Publication Date
AU2021364523A1 true AU2021364523A1 (en) 2023-04-06

Family

ID=78622033

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2021364523A Pending AU2021364523A1 (en) 2020-10-19 2021-10-19 Compositions suitable for use in neonates

Country Status (24)

Country Link
US (1) US20230381285A1 (cg-RX-API-DMAC10.html)
EP (2) EP4228676B1 (cg-RX-API-DMAC10.html)
JP (2) JP7827315B2 (cg-RX-API-DMAC10.html)
KR (1) KR20230113287A (cg-RX-API-DMAC10.html)
CN (1) CN117098547A (cg-RX-API-DMAC10.html)
AU (1) AU2021364523A1 (cg-RX-API-DMAC10.html)
CA (1) CA3194764A1 (cg-RX-API-DMAC10.html)
DK (1) DK4228676T3 (cg-RX-API-DMAC10.html)
ES (1) ES3005966T3 (cg-RX-API-DMAC10.html)
FI (1) FI4228676T3 (cg-RX-API-DMAC10.html)
HR (1) HRP20250193T1 (cg-RX-API-DMAC10.html)
HU (1) HUE070409T2 (cg-RX-API-DMAC10.html)
IL (1) IL301688A (cg-RX-API-DMAC10.html)
LT (1) LT4228676T (cg-RX-API-DMAC10.html)
MX (1) MX2023004426A (cg-RX-API-DMAC10.html)
PL (1) PL4228676T3 (cg-RX-API-DMAC10.html)
PT (1) PT4228676T (cg-RX-API-DMAC10.html)
RS (1) RS66493B1 (cg-RX-API-DMAC10.html)
SA (1) SA523440271B1 (cg-RX-API-DMAC10.html)
SI (1) SI4228676T1 (cg-RX-API-DMAC10.html)
SM (1) SMT202500093T1 (cg-RX-API-DMAC10.html)
TW (1) TWI912393B (cg-RX-API-DMAC10.html)
WO (1) WO2022086953A1 (cg-RX-API-DMAC10.html)
ZA (1) ZA202303162B (cg-RX-API-DMAC10.html)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20250099541A1 (en) 2022-01-19 2025-03-27 Oak Hill Bio Ltd Compositions and methods for reducing oxidation of igf-1/igfbp
CA3248280A1 (en) 2022-05-04 2023-11-09 Oak Hill Bio Limited POLYTHERAPY FOR PREMATURE INFANTS
WO2023242439A1 (en) * 2022-06-17 2023-12-21 Oak Hill Bio Limited Vascular stabilisation (preterm infants)
WO2023242440A1 (en) * 2022-06-17 2023-12-21 Oak Hill Bio Limited Treament of lungs in infants
EP4598630A1 (en) * 2022-10-04 2025-08-13 Oak Hill Bio Limited Method of treating neonates with igf-1 complex

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL71991A (en) 1983-06-06 1994-05-30 Genentech Inc Preparation of human FGI and FGE in their processed form through recombinant AND tranology in prokaryotes
ATE90690T1 (de) 1987-04-06 1993-07-15 Celtrix Pharma Menschliche somatomedin-traeger-proteinuntereinheiten und verfahren zu ihrer herstellung.
DK131988A (da) 1988-03-11 1989-09-12 Erasmus University Igf-bindingsprotein, dna-struktur, der koder for igf-bindingsproteinet og vektor indeholdende denne dna-struktur
US5258287A (en) 1988-03-22 1993-11-02 Genentech, Inc. DNA encoding and methods of production of insulin-like growth factor binding protein BP53
ATE132164T1 (de) 1988-04-12 1996-01-15 Amgen Boulder Inc Verfahren zur steigerung und zur hemmung der wirkung eines insulinähnlichen wachstumfaktors
GB8826451D0 (en) 1988-11-11 1988-12-14 Sandoz Ltd Improvements in/relating to organic compounds
IL92816A0 (en) 1988-12-22 1990-09-17 Biogrowth Inc Recombinant dna molecules,hosts,processes and human somatomedin carrier protein-like polypeptides
EP0639981A4 (en) 1992-05-08 1995-06-28 Univ Jefferson ANALOGS OF THE IGF FACTOR (01/18/94).
US5563046A (en) 1993-08-02 1996-10-08 Celtrix Pharmaceuticals, Inc. Fusion polypeptides and proteins
US5789547A (en) 1995-06-07 1998-08-04 Celtrix Pharmaceuticals, Inc. Method of producing insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) with correct folding and disulfide bonding
US5783556A (en) * 1996-08-13 1998-07-21 Genentech, Inc. Formulated insulin-containing composition
EP0956041A1 (en) * 1996-09-16 1999-11-17 Dalhousie University Use of igf-i for the treatment of polycystic kidney disease and related indications
US6121416A (en) 1997-04-04 2000-09-19 Genentech, Inc. Insulin-like growth factor agonist molecules
US6436897B2 (en) * 1998-06-01 2002-08-20 Celtrix Pharmaceuticals, Inc. Pharmaceutical formulations for IGF/IGFBP
US20020028764A1 (en) * 2000-09-04 2002-03-07 Aarhus Amt. Treatment of acute and chronic liver disease
JP2008543839A (ja) * 2005-06-14 2008-12-04 アムジェン インコーポレーテッド 自己緩衝タンパク質製剤
RU2558821C2 (ru) * 2009-11-17 2015-08-10 Ипсен Фарма С.А.С. ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОМБИНАЦИИ hGH И rhIGF-1
US20110152188A1 (en) * 2009-12-23 2011-06-23 Hanns-Christian Mahler Pharmaceutical compositions of igf/i proteins
CA2897062A1 (en) * 2013-01-15 2014-07-24 Teva Pharmaceutical Industries Ltd. Lyophilization process
KR20140119396A (ko) * 2013-03-29 2014-10-10 삼성전자주식회사 단백질 약물의 액상 제형
EP3681602B1 (en) * 2017-09-11 2026-04-15 Oak Hill Bio Limited Compositions for reducing the incidence of bpd
US20250099541A1 (en) * 2022-01-19 2025-03-27 Oak Hill Bio Ltd Compositions and methods for reducing oxidation of igf-1/igfbp
WO2023139250A1 (en) * 2022-01-24 2023-07-27 Oak Hill Bio Limited Lot release assays for igf‐1/igfbp complexes

Also Published As

Publication number Publication date
PT4228676T (pt) 2025-01-24
JP2026102579A (ja) 2026-06-23
SMT202500093T1 (it) 2025-03-12
IL301688A (en) 2023-05-01
WO2022086953A9 (en) 2022-07-07
JP2023550203A (ja) 2023-11-30
ES3005966T3 (en) 2025-03-17
MX2023004426A (es) 2023-08-04
LT4228676T (lt) 2025-02-10
CN117098547A (zh) 2023-11-21
HUE070409T2 (hu) 2025-06-28
HRP20250193T1 (hr) 2025-04-11
SA523440271B1 (ar) 2025-04-10
EP4534073A2 (en) 2025-04-09
EP4228676A1 (en) 2023-08-23
US20230381285A1 (en) 2023-11-30
SI4228676T1 (sl) 2025-03-31
WO2022086953A1 (en) 2022-04-28
TWI912393B (zh) 2026-01-21
KR20230113287A (ko) 2023-07-28
FI4228676T3 (fi) 2025-02-26
CA3194764A1 (en) 2022-04-28
EP4534073A3 (en) 2025-05-14
RS66493B1 (sr) 2025-03-31
DK4228676T3 (da) 2025-01-20
PL4228676T3 (pl) 2025-04-07
EP4228676B1 (en) 2025-01-08
JP7827315B2 (ja) 2026-03-10
ZA202303162B (en) 2024-08-28
TW202233228A (zh) 2022-09-01

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