AU2020287084B2 - Alkaline phosphatase formulations and uses thereof - Google Patents

Alkaline phosphatase formulations and uses thereof

Info

Publication number
AU2020287084B2
AU2020287084B2 AU2020287084A AU2020287084A AU2020287084B2 AU 2020287084 B2 AU2020287084 B2 AU 2020287084B2 AU 2020287084 A AU2020287084 A AU 2020287084A AU 2020287084 A AU2020287084 A AU 2020287084A AU 2020287084 B2 AU2020287084 B2 AU 2020287084B2
Authority
AU
Australia
Prior art keywords
iap
weight
modified
release
based agent
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.)
Active
Application number
AU2020287084A
Other languages
English (en)
Other versions
AU2020287084A1 (en
AU2020287084A2 (en
Inventor
Andrew BRISTOL
Cristina Freire
Steven Hubert
Michael Kaleko
Ray STAPLETON
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.)
Theriva Biologics Inc
Original Assignee
Theriva Biologics 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 Theriva Biologics Inc filed Critical Theriva Biologics Inc
Publication of AU2020287084A1 publication Critical patent/AU2020287084A1/en
Assigned to THERIVA BIOLOGICS, INC. reassignment THERIVA BIOLOGICS, INC. Amend patent request/document other than specification (104) Assignors: SYNTHETIC BIOLOGICS, INC.
Publication of AU2020287084A2 publication Critical patent/AU2020287084A2/en
Application granted granted Critical
Publication of AU2020287084B2 publication Critical patent/AU2020287084B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/16—Hydrolases (3) acting on ester bonds (3.1)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y201/00—Transferases transferring one-carbon groups (2.1)
    • C12Y201/03—Carboxy- and carbamoyltransferases (2.1.3)
    • C12Y201/03001—Methylmalonyl-CoA carboxytransferase (2.1.3.1)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/03—Phosphoric monoester hydrolases (3.1.3)
    • C12Y301/03001—Alkaline phosphatase (3.1.3.1)

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
AU2020287084A 2019-06-03 2020-06-03 Alkaline phosphatase formulations and uses thereof Active AU2020287084B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962856309P 2019-06-03 2019-06-03
US62/856,309 2019-06-03
PCT/US2020/035814 WO2020247421A1 (en) 2019-06-03 2020-06-03 Alkaline phosphatase formulations and uses thereof

Publications (3)

Publication Number Publication Date
AU2020287084A1 AU2020287084A1 (en) 2021-12-02
AU2020287084A2 AU2020287084A2 (en) 2023-06-29
AU2020287084B2 true AU2020287084B2 (en) 2025-12-18

Family

ID=73653033

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020287084A Active AU2020287084B2 (en) 2019-06-03 2020-06-03 Alkaline phosphatase formulations and uses thereof

Country Status (8)

Country Link
US (1) US20220323367A1 (https=)
EP (1) EP3975999A4 (https=)
JP (2) JP2022535401A (https=)
KR (1) KR20220016199A (https=)
CN (2) CN119896726A (https=)
AU (1) AU2020287084B2 (https=)
CA (1) CA3142240A1 (https=)
WO (1) WO2020247421A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20220005560A (ko) 2019-05-06 2022-01-13 신세틱 바이오로직스, 인코퍼레이티드 알칼리성 포스페이트-기반 종양학 치료제
KR20220111693A (ko) 2019-12-09 2022-08-09 알렉시온 파마슈티칼스, 인코포레이티드 알칼리성 포스파타제 폴리펩티드 및 이의 이용 방법
US12083169B2 (en) * 2021-02-12 2024-09-10 Alexion Pharmaceuticals, Inc. Alkaline phosphatase polypeptides and methods of use thereof
WO2023141560A2 (en) * 2022-01-20 2023-07-27 Synthetic Biologics, Inc. Alkaline phosphatase for use in oncology
US20260048103A1 (en) * 2022-08-09 2026-02-19 Theriva Biologics, Inc. Treatment or prevention of gastrointestinal immunotherapy side effects
CN118216620A (zh) * 2024-05-24 2024-06-21 中国农业科学院北京畜牧兽医研究所 牛碱性磷酸酶bIAP作为饲料添加剂用于抵抗产气荚膜梭菌感染肉鸡所致感染症状的应用

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4537776A (en) 1983-06-21 1985-08-27 The Procter & Gamble Company Penetrating topical pharmaceutical compositions containing N-(2-hydroxyethyl) pyrrolidone
PT1355919E (pt) 2000-12-12 2011-03-02 Medimmune Llc Moléculas com semivida longa, composições que as contêm e suas utilizações
US7048914B2 (en) 2002-12-12 2006-05-23 Zoltan Laboratories Placental alkaline phosphatase to control diabetes
ES2280891T3 (es) * 2003-12-04 2007-09-16 F. Hoffmann-La Roche Ag Metodo para obtener polinucleotidos circulares mutados y/o quimericos.
CA2554683C (en) * 2004-02-04 2014-06-10 Pharmaaware Sepsis B.V. Use of alkaline phosphatase for the detoxification of lps present at mucosal barriers
WO2008001341A1 (en) * 2006-06-27 2008-01-03 Biovail Laboratories International Srl Multiparticulate osmotic delivery system
US9023352B2 (en) 2007-02-20 2015-05-05 Tufts University Methods, compositions and kits for treating a subject using a recombinant heteromultimeric neutralizing binding protein
EP1985697A1 (en) * 2007-04-27 2008-10-29 AM-Pharma B.V. Modified phosphatases
WO2010025267A2 (en) 2008-08-29 2010-03-04 The General Hospital Corporation Methods of modulating gastrointestinal tract flora levels with alkaline phosphatase
EP2570120B1 (en) * 2010-06-08 2017-10-25 Kobe Gakuin Educational Foundation Coated particle and method for producing coated particle
KR101243938B1 (ko) * 2010-10-19 2013-03-19 이희엽 타크롤리무스를 유효성분으로 함유하는 서방형 펠렛
US20130251701A1 (en) 2010-10-22 2013-09-26 Zoltan Kiss Consulting Alkaline phosphatase to correct insulin resistance, hyperinsulinemia, and dyslipidemia
CN102743339B (zh) * 2012-07-20 2015-01-14 苏州大学 一种碱性磷酸酶纳微颗粒及其制备方法
CA2899925A1 (en) 2013-02-04 2014-08-07 Seres Therapeutics, Inc. Compositions and methods for inhibition of pathogenic bacterial growth
EP3125870A4 (en) 2014-04-04 2017-12-13 Alba Therapeutics Corporation Methods of treating celiac disease with larazotide
RU2016138847A (ru) 2014-04-07 2018-05-07 Хэлф Ресерч, Инк. Композиции и способы, относящиеся к покоящимся предрасположенным к старению клеткам (DSPC)
CN106890326A (zh) 2015-12-21 2017-06-27 青岛黄海制药有限责任公司 一种含复合磷酸酯酶的肠溶微丸及其制备
AU2017297718B2 (en) * 2016-07-11 2023-06-08 Contera Pharma A/S Pulsatile drug delivery system for treating morning akinesia
WO2018175413A1 (en) * 2017-03-21 2018-09-27 Synthetic Biologics, Inc. Alkaline phosphatase formulations
WO2019183208A1 (en) 2018-03-20 2019-09-26 Synthetic Biologics, Inc. Intestinal alkaline phosphatase formulations

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
RENTEA, REBECCA M.; et al. 'Radiation-induced changes in intestinal and tissue-nonspecific alkaline phosphatase: implications for recovery after radiation therapy' THE AMERICAN JOURNAL OF SURGERY, VOL. 212, NO. 4, PP 602-608. *

Also Published As

Publication number Publication date
AU2020287084A1 (en) 2021-12-02
AU2020287084A2 (en) 2023-06-29
WO2020247421A1 (en) 2020-12-10
EP3975999A1 (en) 2022-04-06
CN119896726A (zh) 2025-04-29
KR20220016199A (ko) 2022-02-08
JP2022535401A (ja) 2022-08-08
EP3975999A4 (en) 2023-07-19
CN114222561A (zh) 2022-03-22
JP2025027050A (ja) 2025-02-26
US20220323367A1 (en) 2022-10-13
CA3142240A1 (en) 2020-12-10

Similar Documents

Publication Publication Date Title
AU2020287084B2 (en) Alkaline phosphatase formulations and uses thereof
US12508304B2 (en) Alkaline phosphatase formulations
KR102467968B1 (ko) 베타-락타마제 제형 및 이의 용도
US12472147B2 (en) Intestinal alkaline phosphatase formulations
US20210189358A1 (en) Methods of making alkaline phosphatase agents
EP4275761A2 (en) Alkaline phosphatase agents for treatment of radiation disorders
ES3023261T3 (en) Beta-lactamase compositions for treatment of graft versus host disease
EP3999637B1 (en) Intestinal alkaline phosphatase-based treatments of metabolic disorders
EP4347017A1 (en) Alkaline phosphatase-based treatments of celiac disease

Legal Events

Date Code Title Description
HB Alteration of name in register

Owner name: THERIVA BIOLOGICS, INC.

Free format text: FORMER NAME(S): SYNTHETIC BIOLOGICS, INC.

DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS AS SHOWN IN THE STATEMENT FILED 29 MAY 2023

FGA Letters patent sealed or granted (standard patent)