WO2021092439A1 - Methods of treating depressive disorders - Google Patents

Methods of treating depressive disorders Download PDF

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Publication number
WO2021092439A1
WO2021092439A1 PCT/US2020/059481 US2020059481W WO2021092439A1 WO 2021092439 A1 WO2021092439 A1 WO 2021092439A1 US 2020059481 W US2020059481 W US 2020059481W WO 2021092439 A1 WO2021092439 A1 WO 2021092439A1
Authority
WO
WIPO (PCT)
Prior art keywords
compound
human
administered
dose
disorder
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/US2020/059481
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English (en)
French (fr)
Inventor
Cynthia Louise HARDEN
Gregory N. Beatch
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.)
Xenon Pharmaceuticals Inc
Original Assignee
Xenon Pharmaceuticals 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
Priority to PH1/2022/551110A priority Critical patent/PH12022551110A1/en
Priority to PE2022000702A priority patent/PE20221766A1/es
Priority to CR20220250A priority patent/CR20220250A/es
Priority to KR1020227017725A priority patent/KR20220098746A/ko
Priority to MA56607A priority patent/MA56607A1/fr
Priority to BR112022008580A priority patent/BR112022008580A2/pt
Priority to JP2022524695A priority patent/JP2022553569A/ja
Priority to MX2022005490A priority patent/MX2022005490A/es
Priority to NZ787838A priority patent/NZ787838B2/en
Priority to EP20816351.9A priority patent/EP4054580A1/en
Priority to AU2020380961A priority patent/AU2020380961A1/en
Priority to CN202080077815.3A priority patent/CN114667146A/zh
Application filed by Xenon Pharmaceuticals Inc filed Critical Xenon Pharmaceuticals Inc
Priority to CA3155812A priority patent/CA3155812A1/en
Publication of WO2021092439A1 publication Critical patent/WO2021092439A1/en
Priority to IL292678A priority patent/IL292678A/en
Anticipated expiration legal-status Critical
Priority to CONC2022/0008001A priority patent/CO2022008001A2/es
Priority to JP2025155966A priority patent/JP2026001049A/ja
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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/472—Non-condensed isoquinolines, e.g. papaverine
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61P25/24—Antidepressants

Definitions

  • FIG. 2 shows results of the mouse forced swim test including a graphical representation of the average time immobile (2-6 min)(sec, y-axis) for vehicle, 1 mg/kg Compound A, 3 mg/kg Compound A, and imipramine dosing (x-axis).
  • the therapeutically effective amount of Compound A may be orally administered to the subject, for example, between about 30 minutes prior to about 2 hours after eating a meal, most advantageously, the dosage unit of Compound A is orally administered during a meal or within 15 minutes after eating a meal.
  • “Under fasted conditions” refers to the condition of not having consumed food during the time period between from at least 4 hours prior to the oral administration of a therapeutically effective amount of Compound A to about 4 hours after administration of Compound A.
  • the present disclosure is directed to a method of treating obsessive-compulsive disorder (OCD), panic disorder, social anxiety disorder, social phobia, agoraphobia, agoraphobia with panic disorder, hypochondriasis, post-traumatic stress disorder (PTSD), treatment-resistant bipolar disorder, generalized anxiety disorder, attention- deficit/hyperactivity disorder (ADHD), bipolar I disorder, bipolar II disorder, manic disorder, cyclothymic disorder and bipolar disorder not otherwise specified, dysthymic disorder, depressive disorder not otherwise specified, minor depression, recurrent brief depressive disorder, depressive-type psychosis, impulse-control disorders, schizophrenia, schizophreniform disorder, schizoaffective disorder, Parkinson's disease, dementia, Alzheimer's disease, Huntington's disease, Tourette's syndrome, aggression, and substance use and/or abuse, or a combination thereof, comprising administering a therapeutically effective amount of Compound A to a human in need thereof.
  • OCD obsessive-compulsive disorder
  • More specific representative amounts include 0.05 mg/kg, 0.10 mg/kg, 0.20 mg/kg, 0.30 mg/kg, 0.40 mg/kg, 0.5 mg/kg, 0.6 mg/kg, 0.7 mg/kg, 0.80 mg/kg, 0.90 mg/kg, 1.0 mg/kg, 1.1 mg/kg, 1.2 mg/kg, 1.3 mg/kg, 1.4 mg/kg, 1.5 mg/kg, 1.6 mg/kg, 1.7 mg/kg, 1.8 mg/kg, 1.9 mg/kg and 2.0 mg/kg, or any range of amounts created by using two of the aforementioned amounts as endpoints.
  • the method or use includes administering (e.g., orally) 0.1-1.0 mg/kg of Compound A.
  • the method includes administering (e.g., orally) 0.2-0.5 mg/kg of Compound A.
  • the method or use includes orally administering 10 to 200 mg of Compound A per day, such as 10, 15, 20, 25, 30, 35, or 40 mg to 75, 100, 125, 150, 175, or 200 mg of Compound A per day, including 20 to 150 mg per day.
  • the oral administration includes 50, 75, 100, or 125 mg of Compound A per day, such as 100 mg per day.
  • Drug Treatment Compound A and imipramine are formulated and administered at the concentrations described in Table 2 of Example 1 above and dosed 30 min before the TST. For each experiment, at least one control group is included, handled, and tested in parallel under strictly identical experimental conditions.
  • Rats (Wistar rats for some experiments and PVG hooded rats for other experiments) are housed in pairs and allowed 2 weeks to acclimatize before surgery. They are anesthetized and mounted in a stereotaxic frame with the incisor bar set 2.7 mm below the interaural line.
  • Stainless-steel bipolar electrodes are implanted unilaterally into the ventral tegmental area (VTA) with the electrode tips separated by 0.5 mm.
  • the coordinates used are 3.2 mm anterior to the interaural line, 0.6 mm lateral from the midline and 8.2 mm ventral from the skull surface. Five stainless-steel screws and dental cement are used to anchor the electrode assembly to the skull.
  • One group of rats is subjected to CMS-1 for a period of 9 weeks, while the other group is maintained under standard laboratory conditions.
  • the learned helplessness paradigm is a depression model in which animals are exposed to unpredictable and uncontrollable stress, e.g., electroshocks, and subsequently develop coping deficits for aversive but escapable situations.
  • the protocol is described in Chourbaji, S. et al., Brain Res. Protoc. 2005, 16:70-8.
  • the shuttles before the first foot shock (initial activity), as well as the activity in-between the trials (intertrial interval activity or ITI) are recorded.
  • Total time of testing for helplessness lasts about 20-24 min, the exact time period depending on the animal’s ability to leam the paradigm and to respond properly.
  • the apparatus is thoroughly cleaned with 70% ethanol.
  • an additional cohort of animals are tested for immunization. These animals are exposed to a pre-session, identical to the learned helplessness test in the shuttle box, in which they experience a controllable shock condition. Moreover, initial activity during the pre-exposure is monitored.

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  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Neurology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
PCT/US2020/059481 2019-11-08 2020-11-06 Methods of treating depressive disorders Ceased WO2021092439A1 (en)

Priority Applications (16)

Application Number Priority Date Filing Date Title
PE2022000702A PE20221766A1 (es) 2019-11-08 2020-11-06 Metodos para el tratamiento de trastornos depresivos
CR20220250A CR20220250A (es) 2019-11-08 2020-11-06 Métodos para el tratamiento de trastornos depresivos
KR1020227017725A KR20220098746A (ko) 2019-11-08 2020-11-06 우울 장애 치료 방법
MA56607A MA56607A1 (fr) 2019-11-08 2020-11-06 Méthodes de traitement de troubles dépressifs
BR112022008580A BR112022008580A2 (pt) 2019-11-08 2020-11-06 Métodos para tratar transtornos depressivos
JP2022524695A JP2022553569A (ja) 2019-11-08 2020-11-06 うつ病性障害の治療方法
MX2022005490A MX2022005490A (es) 2019-11-08 2020-11-06 Metodos para el tratamiento de trastornos depresivos.
EP20816351.9A EP4054580A1 (en) 2019-11-08 2020-11-06 Methods of treating depressive disorders
NZ787838A NZ787838B2 (en) 2020-11-06 Methods of treating depressive disorders
PH1/2022/551110A PH12022551110A1 (en) 2019-11-08 2020-11-06 Methods of treating depressive disorders
CN202080077815.3A CN114667146A (zh) 2019-11-08 2020-11-06 治疗抑郁症的方法
AU2020380961A AU2020380961A1 (en) 2019-11-08 2020-11-06 Methods of treating depressive disorders
CA3155812A CA3155812A1 (en) 2019-11-08 2020-11-06 Methods of treating depressive disorders
IL292678A IL292678A (en) 2019-11-08 2022-05-02 Methods for treating depressive disorders
CONC2022/0008001A CO2022008001A2 (es) 2019-11-08 2022-06-06 Métodos para el tratamiento de trastornos depresivos
JP2025155966A JP2026001049A (ja) 2019-11-08 2025-09-19 うつ病性障害の治療方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962932724P 2019-11-08 2019-11-08
US62/932,724 2019-11-08

Publications (1)

Publication Number Publication Date
WO2021092439A1 true WO2021092439A1 (en) 2021-05-14

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2020/059481 Ceased WO2021092439A1 (en) 2019-11-08 2020-11-06 Methods of treating depressive disorders

Country Status (19)

Country Link
US (2) US12178811B2 (enExample)
EP (1) EP4054580A1 (enExample)
JP (2) JP2022553569A (enExample)
KR (1) KR20220098746A (enExample)
CN (1) CN114667146A (enExample)
AU (1) AU2020380961A1 (enExample)
BR (1) BR112022008580A2 (enExample)
CA (1) CA3155812A1 (enExample)
CL (1) CL2022001102A1 (enExample)
CO (1) CO2022008001A2 (enExample)
CR (1) CR20220250A (enExample)
GE (2) GEP20257732B (enExample)
IL (1) IL292678A (enExample)
MA (1) MA56607A1 (enExample)
MX (1) MX2022005490A (enExample)
PE (1) PE20221766A1 (enExample)
PH (1) PH12022551110A1 (enExample)
TW (1) TW202128162A (enExample)
WO (1) WO2021092439A1 (enExample)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022173855A1 (en) * 2021-02-09 2022-08-18 Xenon Pharmaceuticals Inc. Voltage-gated potassium channel opener for use in treating anhedonia
EP4069226A1 (en) 2019-12-06 2022-10-12 Icahn School of Medicine at Mount Sinai Method of treatment with kcnq channel openers
US12178811B2 (en) 2019-11-08 2024-12-31 Xenon Pharmaceuticals Inc. Methods of treating depressive disorders

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GEAP202416349A (en) * 2021-02-09 2024-02-12 Xenon Pharmaceuticals Inc Conjoint therapy for treating seizure disorders
EP4392125A1 (en) * 2021-10-08 2024-07-03 Albert-Ludwigs-Universität Freiburg Treatment of psychiatric disorders with deep brain stimulation

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