WO2022245532A1 - Compositions for treatment of neurodegenerative conditions - Google Patents

Compositions for treatment of neurodegenerative conditions Download PDF

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Publication number
WO2022245532A1
WO2022245532A1 PCT/US2022/027294 US2022027294W WO2022245532A1 WO 2022245532 A1 WO2022245532 A1 WO 2022245532A1 US 2022027294 W US2022027294 W US 2022027294W WO 2022245532 A1 WO2022245532 A1 WO 2022245532A1
Authority
WO
WIPO (PCT)
Prior art keywords
triol
ethynylandrost
ene
pharmaceutical composition
several embodiments
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/US2022/027294
Other languages
English (en)
French (fr)
Inventor
Clarence Nathaniel Ahlem
Christopher L. Reading
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.)
Biovie Inc
Original Assignee
Biovie 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 Biovie Inc filed Critical Biovie Inc
Priority to CA3218191A priority Critical patent/CA3218191A1/en
Priority to AU2022275684A priority patent/AU2022275684A1/en
Priority to MX2023013616A priority patent/MX2023013616A/es
Priority to JP2023571820A priority patent/JP2024519079A/ja
Priority to EP22805164.5A priority patent/EP4341271A4/en
Publication of WO2022245532A1 publication Critical patent/WO2022245532A1/en
Priority to US18/511,027 priority patent/US20240108636A1/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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61K31/13—Amines
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs

Definitions

  • LID levodopa-induced dyskinesia
  • Non-limiting examples of suitable dopamine precursors include carbidopa, L-dopa (i.e., levodopa), entacapone, COMTAN, DUOPA, INBRIJA, RYTARY, SINEMET, SINEMET CR, and STALEVO.
  • the additional medicament comprises L-dopa.
  • the additional medicament is administered at a delay time after a first administration of the composition.
  • the first administration may occur using a dosage schedule that is daily, weekly, monthly, or any combination of the foregoing.
  • the dosage schedule of the first administration may include one, two, three or more daily dosages of the composition.
  • the use includes a delay time after use of the medicament begins.
  • the delay time is equal to or greater than 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 years, or ranges including and/or spanning the aforementioned values.
  • the delay time is equal to or greater than 2 years.
  • the use includes development of at least one motor symptom. Such motor symptoms are described elsewhere herein.
  • the motor symptom develops at a time after the use of the medicament begins that is 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 years, or ranges including and/or spanning the aforementioned values.
  • SNCA Under conditions of ER stress, SNCA can be misfolded and aggregated into oligomeric sheets that are toxic to mitochondria in addition to activating molecular pattern receptors and inflammatory pathways.
  • Insulin signaling plays a vital role in neuronal energy homeostasis and neuron survival. Inflammatory activation of mitogen associated protein kinases (MAPK) can inhibit insulin signaling (induce insulin resistance) through phosphorylation of various serine residues on insulin receptor substrate 1 and 2 (IRS-1/2) that interfere with insulin receptor tyrosine phosphorylation or interactions of IRS-1/2 with the insulin receptor or other proteins in the signaling complex.
  • MPK mitogen associated protein kinases

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Neurology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Psychology (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Saccharide Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
PCT/US2022/027294 2021-05-18 2022-05-02 Compositions for treatment of neurodegenerative conditions Ceased WO2022245532A1 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CA3218191A CA3218191A1 (en) 2021-05-18 2022-05-02 Compositions for treatment of neurodegenerative conditions
AU2022275684A AU2022275684A1 (en) 2021-05-18 2022-05-02 Compositions for treatment of neurodegenerative conditions
MX2023013616A MX2023013616A (es) 2021-05-18 2022-05-02 Composiciones para el tratamiento de condiciones neurodegenerativas.
JP2023571820A JP2024519079A (ja) 2021-05-18 2022-05-02 神経変性状態の治療のための組成物
EP22805164.5A EP4341271A4 (en) 2021-05-18 2022-05-02 Compositions for treatment of neurodegenerative conditions
US18/511,027 US20240108636A1 (en) 2021-05-18 2023-11-16 Compositions for treatment of neurodegenerative conditions

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163189880P 2021-05-18 2021-05-18
US63/189,880 2021-05-18

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US18/511,027 Continuation US20240108636A1 (en) 2021-05-18 2023-11-16 Compositions for treatment of neurodegenerative conditions

Publications (1)

Publication Number Publication Date
WO2022245532A1 true WO2022245532A1 (en) 2022-11-24

Family

ID=84141848

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2022/027294 Ceased WO2022245532A1 (en) 2021-05-18 2022-05-02 Compositions for treatment of neurodegenerative conditions

Country Status (7)

Country Link
US (1) US20240108636A1 (enExample)
EP (1) EP4341271A4 (enExample)
JP (1) JP2024519079A (enExample)
AU (1) AU2022275684A1 (enExample)
CA (1) CA3218191A1 (enExample)
MX (1) MX2023013616A (enExample)
WO (1) WO2022245532A1 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024054452A1 (en) * 2022-09-06 2024-03-14 Biovie Inc. Methods for the treatment of mild cognitive impairment
WO2025155561A1 (en) * 2024-01-16 2025-07-24 Biovie Inc. Methods of treating long covid

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070015763A1 (en) * 2005-07-12 2007-01-18 Pfizer Inc Treatment of psychosis associated with parkinson's disease and subcortical dementias using a combination of an atypical antipsychotic with a dopamine agonist
US9850271B2 (en) * 2008-04-03 2017-12-26 Neurmedix, Inc. Crystalline solvate forms of a pharmaceutical

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070015763A1 (en) * 2005-07-12 2007-01-18 Pfizer Inc Treatment of psychosis associated with parkinson's disease and subcortical dementias using a combination of an atypical antipsychotic with a dopamine agonist
US9850271B2 (en) * 2008-04-03 2017-12-26 Neurmedix, Inc. Crystalline solvate forms of a pharmaceutical
US20180208623A1 (en) * 2008-04-03 2018-07-26 Neurmedix, Inc. Crystalline solvate forms of a pharmaceutical

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4341271A4 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024054452A1 (en) * 2022-09-06 2024-03-14 Biovie Inc. Methods for the treatment of mild cognitive impairment
WO2025155561A1 (en) * 2024-01-16 2025-07-24 Biovie Inc. Methods of treating long covid

Also Published As

Publication number Publication date
AU2022275684A1 (en) 2023-11-16
EP4341271A1 (en) 2024-03-27
JP2024519079A (ja) 2024-05-08
US20240108636A1 (en) 2024-04-04
EP4341271A4 (en) 2025-04-30
CA3218191A1 (en) 2022-11-24
MX2023013616A (es) 2024-01-17

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Free format text: APRESENTE DOCUMENTO DE CESSAO ESPECIFICO PARA A PRIORIDADE US 63/189,880 DE 18/05/2021 UMA VEZ QUE O DOCUMENTO ENVIADO NA PETICAO NO 870240004049 DE 16/01/2024 NAO POSSUI ASSINATURA. A CESSAO DEVE CONTER A ASSINATURA DE TODOS OS TITULARES, CONFORME DISPOSTO NO ART. 19 3O DA PORTARIA/INPI/NO 39/2021. A EXIGENCIA DEVE SER RESPONDIDA EM ATE 60 (SESSENTA) DIAS DE SUA PUBLICACAO E DEVE SER REALIZADA POR MEIO DA PETICAO GRU CODIGO DE SERVICO 207.

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