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WO2018029505A1 - Thérapie de cer-001 pour le traitement de l'hypoalphalipoprotéinémie familiale. - Google Patents

Thérapie de cer-001 pour le traitement de l'hypoalphalipoprotéinémie familiale. Download PDF

Info

Publication number
WO2018029505A1
WO2018029505A1 PCT/IB2016/001348 IB2016001348W WO2018029505A1 WO 2018029505 A1 WO2018029505 A1 WO 2018029505A1 IB 2016001348 W IB2016001348 W IB 2016001348W WO 2018029505 A1 WO2018029505 A1 WO 2018029505A1
Authority
WO
WIPO (PCT)
Prior art keywords
cer
subject
administered
doses
regimen
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/IB2016/001348
Other languages
English (en)
Inventor
Constance HECKLAU PEYROTTES
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.)
Abionyx Pharma SA
Original Assignee
Cerenis Therapeutics Holding SA
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 Cerenis Therapeutics Holding SA filed Critical Cerenis Therapeutics Holding SA
Priority to PCT/IB2016/001348 priority Critical patent/WO2018029505A1/fr
Publication of WO2018029505A1 publication Critical patent/WO2018029505A1/fr
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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/66—Phosphorus compounds
    • A61K31/661—Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
    • A61K31/6615—Compounds having two or more esterified phosphorus acid groups, e.g. inositol triphosphate, phytic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/66—Phosphorus compounds
    • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • A61K31/688—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols both hydroxy compounds having nitrogen atoms, e.g. sphingomyelins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Definitions

  • the dosage of CER-001 used during the induction phase is 400 mg to 1500 mg, 500 mg to 1200 mg, or 500 mg to 1000 mg per administration.
  • patient is given a single intravenous infusion of either placebo or CER-001 (8mg/kg) diluted in normal saline to a volume of 250 ml over a one hour period using an infusion pump at a fixed rate of 250 ml/hr.
  • Study drug administration may be extended up to a period of 120 minutes if deemed medically necessary for the patient by the Investigator.
  • a method for treating a subject in need of long term HDL therapy comprising:
  • 001 administered in the maintenance regimen is 0.5 to 8 mg/kg (on a protein weight basis).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention porte sur le traitement d'un sujet par l'administration de CER-001. Le régime d'induction comprend l'administration de multiples doses de CER-001 pendant cinq jours ou plus, puis l'administration de CER-001 au sujet selon un régime de maintenance.
PCT/IB2016/001348 2016-08-11 2016-08-11 Thérapie de cer-001 pour le traitement de l'hypoalphalipoprotéinémie familiale. Ceased WO2018029505A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2016/001348 WO2018029505A1 (fr) 2016-08-11 2016-08-11 Thérapie de cer-001 pour le traitement de l'hypoalphalipoprotéinémie familiale.

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2016/001348 WO2018029505A1 (fr) 2016-08-11 2016-08-11 Thérapie de cer-001 pour le traitement de l'hypoalphalipoprotéinémie familiale.

Publications (1)

Publication Number Publication Date
WO2018029505A1 true WO2018029505A1 (fr) 2018-02-15

Family

ID=57045227

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2016/001348 Ceased WO2018029505A1 (fr) 2016-08-11 2016-08-11 Thérapie de cer-001 pour le traitement de l'hypoalphalipoprotéinémie familiale.

Country Status (1)

Country Link
WO (1) WO2018029505A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021209823A1 (fr) * 2020-04-16 2021-10-21 Abionyx Pharma Sa Méthodes de traitement d'affections aiguës faisant appel à des complexes à base de protéines se liant à des lipides
WO2021209808A1 (fr) * 2020-04-16 2021-10-21 Abionyx Pharma Sa Thérapie avec cer-001 pour le traitement d'une maladie rénale
WO2021209822A1 (fr) * 2020-04-16 2021-10-21 Abionyx Pharma Sa Thérapie à base de cer-001 pour le traitement d'une maladie rénale

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012109162A1 (fr) 2011-02-07 2012-08-16 Cerenis Therapeutics Holding S.A. Complexes de lipoprotéines, leur production et leurs utilisations
US20150316566A1 (en) * 2014-05-02 2015-11-05 Cerenis Therapeutics Holding Sa Hdl therapy markers

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012109162A1 (fr) 2011-02-07 2012-08-16 Cerenis Therapeutics Holding S.A. Complexes de lipoprotéines, leur production et leurs utilisations
US20150316566A1 (en) * 2014-05-02 2015-11-05 Cerenis Therapeutics Holding Sa Hdl therapy markers
WO2015173633A2 (fr) 2014-05-02 2015-11-19 Cerenis Therapeutics Holding Sa Marqueurs de thérapie hdl

Non-Patent Citations (22)

* Cited by examiner, † Cited by third party
Title
ATTIE ET AL., J LIPID RES., vol. 42, no. 11, 2001, pages 1717 - 26
CALABRESI; FRANCESCHINI, CURR OPIN LIPIDOL., vol. 8, no. 4, 1997, pages 219 - 24
CERENIS THERAPEUTICS: "CER-001 Therapy as a Novel Approach to Treat Genetic Orphan Diseases (TANGO)", NCT02697136 ON 2016_03_02: CLINICALTRIALS.GOV ARCHIVE, 2 March 2016 (2016-03-02), pages 1 - 4, XP055361832, Retrieved from the Internet <URL:https://clinicaltrials.gov/archive/NCT02697136/2016_03_02> [retrieved on 20170405] *
CERENIS THERAPEUTICS: "NCT02484378: CER-001 Atherosclerosis Regression ACS Trial", 26 June 2015 (2015-06-26), XP055362130, Retrieved from the Internet <URL:https://clinicaltrials.gov/archive/NCT02484378/2015_06_26> [retrieved on 20170405] *
CLEE ET AL., J CLIN INVEST., vol. 106, no. 10, 2000, pages 1263 - 70
DUVERGER ET AL., CIRCULATION, vol. 94, no. 4, 1996, pages 713 - 7
GENEST ET AL., ARTERIOSCLER THROMB., 1993, pages 1728 - 37
GENEST ET AL., CIRCULATION, 1992, pages 2025 - 33
HOVINGH G KEES ET AL: "The effect of an apolipoprotein A-I-containing high-density lipoprotein-mimetic particle (CER-001) on carotid artery wall thickness in patients with homozygous familial hypercholesterolemia The Modifying Orphan Disease Evaluation (MODE) study", AMERICAN HEART JOURNAL, ELSEVIER, AMSTERDAM, NL, vol. 169, no. 5, 27 January 2015 (2015-01-27), pages 736, XP029574003, ISSN: 0002-8703, DOI: 10.1016/J.AHJ.2015.01.008 *
IKEWAKI ET AL., ATHEROSCLEROSIS, vol. 172, no. 1, 2004, pages 39 - 45
KASTELEIN ET AL., EUR HEART J, vol. 37, no. 17, 2016, pages 1360 - 9
KOOTTE ET AL., J LIPID RES., vol. 56, no. 3, 2015, pages 703 - 12
NI ET AL., J LIPID RES., vol. 52, no. 1, 2011, pages 78 - 86
PASZTY ET AL., J CLIN INVEST., vol. 94, no. 2, 1994, pages 899 - 903
PISCIOTTA ET AL., ATHEROSCLEROSIS, vol. 167, no. 2, 2003, pages 335 - 45
PLUMP ET AL., PNAS, vol. 91, no. 20, 1994, pages 9607 - 11
PUNTONI ET AL., AM J CARDIOVASC DRUGS, vol. 12, no. 5, 2012, pages 303 - 11
RUUD S. KOOTTE ET AL: "Effect of open-label infusion of an apoA-I-containing particle (CER-001) on RCT and artery wall thickness in patients with FHA", JOURNAL OF LIPID RESEARCH, vol. 56, no. 3, 5 January 2015 (2015-01-05), US, pages 703 - 712, XP055361798, ISSN: 0022-2275, DOI: 10.1194/jlr.M055665 *
SANTOS ET AL., J LIPID RES., vol. 49, no. 2, 2008, pages 349 - 57
VAN DAM ET AL., LANCET, vol. 359, no. 9300, 2002, pages 37 - 42
VEGA; GRUNDY, CURR OPIN LIPIDOL., vol. 7, no. 4, 1996, pages 209 - 16
YOKOTA ET AL., ATHEROSCLEROSIS, vol. 162, no. 2, 2002, pages 399 - 407

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021209823A1 (fr) * 2020-04-16 2021-10-21 Abionyx Pharma Sa Méthodes de traitement d'affections aiguës faisant appel à des complexes à base de protéines se liant à des lipides
WO2021209808A1 (fr) * 2020-04-16 2021-10-21 Abionyx Pharma Sa Thérapie avec cer-001 pour le traitement d'une maladie rénale
WO2021209822A1 (fr) * 2020-04-16 2021-10-21 Abionyx Pharma Sa Thérapie à base de cer-001 pour le traitement d'une maladie rénale
CN115427064A (zh) * 2020-04-16 2022-12-02 阿比奥尼克斯制药公司 使用基于脂质结合蛋白的复合物治疗急性病况的方法
CN115666720A (zh) * 2020-04-16 2023-01-31 阿比奥尼克斯制药公司 用于治疗肾病的cer-001疗法
US11752163B2 (en) 2020-04-16 2023-09-12 Abionyx Pharma Sa CER-001 therapy for treating kidney disease
US12364705B2 (en) 2020-04-16 2025-07-22 Abionyx Pharma Sa CER-001 therapy for treating kidney disease

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