WO2008016404A3 - Parathyroid hormone analogues and uses thereof - Google Patents

Parathyroid hormone analogues and uses thereof Download PDF

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Publication number
WO2008016404A3
WO2008016404A3 PCT/US2007/010720 US2007010720W WO2008016404A3 WO 2008016404 A3 WO2008016404 A3 WO 2008016404A3 US 2007010720 W US2007010720 W US 2007010720W WO 2008016404 A3 WO2008016404 A3 WO 2008016404A3
Authority
WO
WIPO (PCT)
Prior art keywords
parathyroid hormone
subject
hormone analogues
pth
treating
Prior art date
Application number
PCT/US2007/010720
Other languages
French (fr)
Other versions
WO2008016404A2 (en
Inventor
Paul Morley
Martin Stogniew
Brian Macdonald
Gene Scott Merutka
Nagesh R Palepu
Original Assignee
Zelos Therapeutics Inc
Paul Morley
Martin Stogniew
Brian Macdonald
Gene Scott Merutka
Nagesh R Palepu
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
Priority claimed from US11/517,146 external-priority patent/US20070099831A1/en
Priority claimed from US11/650,918 external-priority patent/US20070270341A1/en
Application filed by Zelos Therapeutics Inc, Paul Morley, Martin Stogniew, Brian Macdonald, Gene Scott Merutka, Nagesh R Palepu filed Critical Zelos Therapeutics Inc
Priority to EP07794515A priority Critical patent/EP2056862A2/en
Priority to JP2009522751A priority patent/JP2010501476A/en
Priority to CA002659846A priority patent/CA2659846A1/en
Publication of WO2008016404A2 publication Critical patent/WO2008016404A2/en
Publication of WO2008016404A3 publication Critical patent/WO2008016404A3/en

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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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 (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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61K9/14—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

The present invention is directed to novel methods of treating a subject with a bone deficit disorder. The methods generally include administering to a subject in need thereof a pharmaceutically acceptable formulation comprising a parathyroid hormone (PTH) peptide analogue in a daily dose sufficient to result in an effective pharmacokinetic profile and maintained adenylate cyclase activity, while simultaneously reducing undesirable side effects.
PCT/US2007/010720 2006-07-31 2007-05-02 Parathyroid hormone analogues and uses thereof WO2008016404A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP07794515A EP2056862A2 (en) 2006-07-31 2007-05-02 Parathyroid hormone analogues and uses thereof
JP2009522751A JP2010501476A (en) 2006-07-31 2007-05-02 Parathyroid hormone analogs and methods of use thereof
CA002659846A CA2659846A1 (en) 2006-07-31 2007-05-02 Parathyroid hormone analogues and methods of use

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
US83498006P 2006-07-31 2006-07-31
US60/834,980 2006-07-31
US83797206P 2006-08-15 2006-08-15
US60/837,972 2006-08-15
US11/517,146 2006-09-06
US11/517,146 US20070099831A1 (en) 2005-09-06 2006-09-06 Parathyroid hormone analogues and methods of use
US11/650,918 2007-01-05
US11/650,918 US20070270341A1 (en) 2005-09-06 2007-01-05 Parathyroid hormone analogues and methods of use
US90569307P 2007-03-07 2007-03-07
US60/905,693 2007-03-07
US92563907P 2007-04-20 2007-04-20
US60/925,639 2007-04-20

Publications (2)

Publication Number Publication Date
WO2008016404A2 WO2008016404A2 (en) 2008-02-07
WO2008016404A3 true WO2008016404A3 (en) 2009-01-15

Family

ID=56290957

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/010720 WO2008016404A2 (en) 2006-07-31 2007-05-02 Parathyroid hormone analogues and uses thereof

Country Status (4)

Country Link
EP (1) EP2056862A2 (en)
JP (1) JP2010501476A (en)
CA (1) CA2659846A1 (en)
WO (1) WO2008016404A2 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011001273A (en) * 2009-06-16 2011-01-06 Eci Inc WATER-SOLUBLE PREPARATION COMPRISING eMIP AS ACTIVE INGREDIENT
WO2014118705A1 (en) * 2013-01-31 2014-08-07 Novartis Ag Methods of treating chronic kidney disease-mineral and bone disorder using sclerostin antagonists
EP3685849A4 (en) * 2017-09-22 2021-12-22 Asahi Kasei Pharma Corporation Teriparatide-containing liquid pharmaceutical composition having excellent stability
US20200289622A1 (en) * 2017-09-22 2020-09-17 Asahi Kasei Pharma Corporation Teriparatide-containing liquid pharmaceutical composition having excellent pharmacokinetics and/or safety

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5556940A (en) * 1994-06-20 1996-09-17 National Research Council Of Canada Parathyroid hormone analogues for the treatment of osteoporosis
US5955425A (en) * 1996-08-02 1999-09-21 National Research Council Of Canada Parathyroid hormone analogues for the treatment of osteoporosis
US6110892A (en) * 1994-06-20 2000-08-29 National Research Council Of Canada Parathyroid hormone analogues for the treatment of osteoporosis
WO2001021643A2 (en) * 1999-09-22 2001-03-29 National Research Council Of Canada Parathyroid hormone analogues for the treatment of osteoporosis
EP1619204A1 (en) * 2004-07-19 2006-01-25 Abiogen Pharma S.p.A. PTH-like peptides

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE253078T1 (en) * 1996-08-02 2003-11-15 Ca Nat Research Council ANALOGUES OF PARATHORMONE FOR THE TREATMENT OF OSTEOPOROSIS

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5556940A (en) * 1994-06-20 1996-09-17 National Research Council Of Canada Parathyroid hormone analogues for the treatment of osteoporosis
US6110892A (en) * 1994-06-20 2000-08-29 National Research Council Of Canada Parathyroid hormone analogues for the treatment of osteoporosis
US6541450B1 (en) * 1994-06-20 2003-04-01 National Research Council Of Canada Parathyroid hormone analogues for the treatment of osteoporosis
US5955425A (en) * 1996-08-02 1999-09-21 National Research Council Of Canada Parathyroid hormone analogues for the treatment of osteoporosis
WO2001021643A2 (en) * 1999-09-22 2001-03-29 National Research Council Of Canada Parathyroid hormone analogues for the treatment of osteoporosis
EP1619204A1 (en) * 2004-07-19 2006-01-25 Abiogen Pharma S.p.A. PTH-like peptides

Non-Patent Citations (15)

* Cited by examiner, † Cited by third party
Title
BONNICK ET AL: "Osteoporosis in men and women", CLINICAL CORNERSTONE, EXCERPTA MEDICA, GB, vol. 8, no. 1, 1 January 2006 (2006-01-01), pages 28 - 39, XP022131180, ISSN: 1098-3597 *
DEAL CHAD ET AL: "Combination teriparatide and raloxifene therapy for postmenopausal osteoporosis: results from a 6-month double-blind placebo-controlled trial.", JOURNAL OF BONE AND MINERAL RESEARCH : THE OFFICIAL JOURNAL OF THE AMERICAN SOCIETY FOR BONE AND MINERAL RESEARCH NOV 2005, vol. 20, no. 11, November 2005 (2005-11-01), pages 1905 - 1911, XP002503733, ISSN: 0884-0431 *
ERIKSEN ERIK F ET AL: "Teriparatide: A bone formation treatment for osteoporosis.", DRUGS OF TODAY (BARCELONA, SPAIN : 1998) NOV 2004, vol. 40, no. 11, November 2004 (2004-11-01), pages 935 - 948, XP002503734, ISSN: 1699-3993 *
MATSUMOTO T ET AL: "DAILY NASAL SPRAY OF HPTH(1-34) FOR 3 MONTHS INCREASES BONE MASS IN OSTEOPOROTIC SUBJECTS", JOURNAL OF BONE AND MINERAL RESEARCH, NEW YORK, NY, US, vol. 19, 1 October 2004 (2004-10-01), pages S44, XP009056897, ISSN: 0884-0431 *
MORLEY P ET AL: "Parathyroid hormone: an anabolic treatment for osteoporosis", CURRENT PHARMACEUTICAL DESIGN, BENTHAM SCIENCE PUBLISHERS, SCHIPHOL, NL, vol. 7, 1 May 2001 (2001-05-01), pages 671 - 687, XP002969213, ISSN: 1381-6128 *
MORLEY PAUL: "DELIVERY OF PARATHYROID HORMONE FOR THE TREATMENT OF OSTEOPOROSIS", EXPERT OPINION ON DRUG DELIVERY, ASHLEY PUBLICATIONS, vol. 2, no. 6, 1 November 2005 (2005-11-01), pages 993 - 1002, XP008076969, ISSN: 1742-5247 *
POOLE ET AL: "Parathyroid hormone - a bone anabolic and catabolic agent", CURRENT OPINION IN PHARMACOLOGY, ELSEVIER SCIENCE PUBLISHERS, NL, vol. 5, no. 6, 1 December 2005 (2005-12-01), pages 612 - 617, XP005134773, ISSN: 1471-4892 *
REIDHAAR-OLSON J F ET AL: "Active variants of human parathyroid hormone (1-34) with multiple amino acid substitutions", MOLECULAR AND CELLULAR ENDOCRINOLOGY, ELSEVIER IRELAND LTD, IE, vol. 160, no. 1-2, 25 February 2000 (2000-02-25), pages 135 - 147, XP002322157, ISSN: 0303-7207 *
SHIMIZU M ET AL: "MINIMIZATION OF PARATHYROID HORMONE NOVEL AMINO-TERMINAL PARATHYROID HORMONE FRAGMENTS WITH ENHANCED POTENCY IN ACTIVATING THE TYPE-1 PARATHYROID HORMONE RECEPTOR", JOURNAL OF BIOLOGICAL CHEMISTRY, AMERICAN SOCIETY OF BIOLOCHEMICAL BIOLOGISTS, BIRMINGHAM,; US, vol. 275, no. 29, 21 July 2000 (2000-07-21), pages 21836 - 21843, XP002939322, ISSN: 0021-9258 *
SORBERA L A: "Ostabolin-C(TM): Parathyroid hormone analogue treatment of osteoporosis treatment of psoriasis", DRUGS OF THE FUTURE 200608 ES, vol. 31, no. 8, August 2006 (2006-08-01), pages 670 - 675, XP002503732, ISSN: 0377-8282 *
WHITFIELD ET AL: "Parathyroid hormone: A novel tool for treating bone marrow depletion in cancer patients caused by chemotherapeutic drugs and ionizing radiation", CANCER LETTERS, NEW YORK, NY, US, vol. 244, no. 1, 6 October 2006 (2006-10-06), pages 8 - 15, XP005839574, ISSN: 0304-3835 *
WHITFIELD J F ET AL: "Comparison of the ability of recombinant human parathyroid hormone, rhPTH-(1-84), and hPTH-(1-31)NH2 to stimulate femoral trabecular bone growth in ovariectomized rats", CALCIFIED TISSUE INTERNATIONAL, NEW YORK, NY, US, vol. 60, no. 1, 1 January 1997 (1997-01-01), pages 26 - 29, XP002249487, ISSN: 0171-967X *
WHITFIELD J F ET AL: "CYCLIZATION BY A SPECIFIC LACTAM INCREASES THE ABILITY OF HUMAN PARATHYROID HORMONE (HPTH)-(1-31)NH2 TO STIMULATE BONE GROWTH IN OVARIECTOMIZED RATS", JOURNAL OF BONE AND MINERAL RESEARCH, NEW YORK, NY, US, vol. 12, no. 8, 1 January 1997 (1997-01-01), pages 1246 - 1252, XP000926228, ISSN: 0884-0431 *
WHITFIELD JAMES F: "Osteoporosis-treating parathyroid hormone peptides: What are they? What do they do? How might they do it?", CURRENT OPINION IN INVESTIGATIONAL DRUGS, PHARMAPRESS, US, vol. 7, no. 4, 1 April 2006 (2006-04-01), pages 349 - 359, XP009104813, ISSN: 1472-4472 *
ZELOS: "Zelos Therapeutics completes enrollment in two ostabolin-C TM phase 2 Clinical Trials", 9 February 2006, XP002503735 *

Also Published As

Publication number Publication date
EP2056862A2 (en) 2009-05-13
WO2008016404A2 (en) 2008-02-07
JP2010501476A (en) 2010-01-21
CA2659846A1 (en) 2008-02-07

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