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WO2022169226A1 - Composition contenant du lonafarnib en tant que principe actif pour la prévention ou le traitement de la sarcopénie - Google Patents

Composition contenant du lonafarnib en tant que principe actif pour la prévention ou le traitement de la sarcopénie Download PDF

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Publication number
WO2022169226A1
WO2022169226A1 PCT/KR2022/001591 KR2022001591W WO2022169226A1 WO 2022169226 A1 WO2022169226 A1 WO 2022169226A1 KR 2022001591 W KR2022001591 W KR 2022001591W WO 2022169226 A1 WO2022169226 A1 WO 2022169226A1
Authority
WO
WIPO (PCT)
Prior art keywords
lonafarnib
sarcopenia
treatment
present
pharmaceutical composition
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/KR2022/001591
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English (en)
Korean (ko)
Inventor
현정근
박성혁
배상훈
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.)
SNU R&DB Foundation
Industry Academic Cooperation Foundation of Dankook University
Original Assignee
Seoul National University R&DB Foundation
Industry Academic Cooperation Foundation of Dankook University
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 Seoul National University R&DB Foundation, Industry Academic Cooperation Foundation of Dankook University filed Critical Seoul National University R&DB Foundation
Priority claimed from KR1020220012880A external-priority patent/KR102729655B1/ko
Publication of WO2022169226A1 publication Critical patent/WO2022169226A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4545—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system

Definitions

  • the present invention relates to a composition for preventing or treating sarcopenia comprising lonafarnib as an active ingredient.
  • Sarcopenia caused by degeneration of spinal nerves, motor nerves, or skeletal muscle fibers is one of the representative intractable diseases for which the cause has not yet been identified.
  • the motor nerve that induces the contraction of the skeletal muscle is degenerated so that the contraction of the skeletal muscle does not proceed, or the expression of the protein involved in the contraction of the muscle in the skeletal muscle is reduced (sarcopenia), or the protein is modified Normal skeletal muscle contraction does not proceed, and it is known that the motor nerve or skeletal muscle is transformed into a fibrous tissue in the long term.
  • degenerative sarcopenia is defined as a decrease in muscle mass associated with aging, and is increasingly recognized as having an important impact on quality of life in old age.
  • Degenerative sarcopenia occurs in 13 to 24% of people under 70 years of age, but occurs in more than 50% of people over 80 years of age. is known to be associated with an increase in Patients with sarcopenia have difficulty in daily life, such as a decrease in grip strength or walking speed, while their skeletal muscle index is below the standard value. In terms of body composition, the amount of muscle is clearly lost, while body fat tends to increase.
  • an object of the present invention is to provide a new pharmaceutical composition capable of preventing, treating or improving sarcopenia, and lonafarnib improves the atrophy of the myoblast formed in myoblasts. By confirming that it exhibits the effect of reducing sarcopenia, it is to provide lonafarnib as a new drug for the prevention, treatment or improvement of sarcopenia.
  • the present invention provides a pharmaceutical composition for preventing or treating sarcopenia comprising Lonafarnib as an active ingredient.
  • the present invention provides a health functional food composition for preventing or improving sarcopenia comprising lonafarnib as an active ingredient.
  • the present invention provides a method for treating sarcopenia comprising administering the pharmaceutical composition in a pharmaceutically effective amount to an individual other than a human suffering from sarcopenia.
  • lonafarnib (Lonafarnib) can be provided as a new drug for the prevention, treatment or improvement of sarcopenia because it exhibits an effect of improving the atrophy of the root canal formed in myoblasts.
  • 3 is a result of evaluating the change in body weight of the animal model according to the concentration of lonafarnib (Lonafarnib) treatment. Data values are mean ⁇ S.D. Statistical analysis was performed by t-test (*: p ⁇ .05, Wild vs Dex; +: p ⁇ .05 Dex vs Lona 5 ⁇ M).
  • TA tibialis anterior
  • GCM gastrocnemius median
  • Figure 5a is the result of evaluating the cross sectional area (CSA) change of the tibialis anterior (TA) of the animal model according to the concentration of lonafarnib (Lonafarnib) treatment
  • Figure 5b is the result of lonafarnib (Lonafarnib) treatment
  • CSA cross sectional area
  • GCM gastrocnemius median
  • Figure 7a is the result of evaluating the compound muscle action potential (CMAP) of the tibialis anterior (TA) of the animal model according to the concentration of lonafarnib treatment by conducting an electromyography test; 7b is the result of evaluating the compound muscle action potential (CMAP) of the gastrocnemius median (GCM) of the animal model according to the lonafarnib treatment concentration by conducting an electromyography test. Data values are mean ⁇ S.D. Statistical analysis was performed by t-test (*: p ⁇ .05).
  • the present invention provides a pharmaceutical composition for preventing or treating sarcopenia comprising Lonafarnib as an active ingredient.
  • the lonafarnib (Lonafarnib) has a C 27 H 31 Br 2 ClN 4 O 2 molecular formula, and is a compound represented by the following formula (1).
  • the lonafarnib (Lonafarnib) is a farnesyltransferase inhibitor (FTI), and exhibits an effect of improving root canal atrophy.
  • FTI farnesyltransferase inhibitor
  • the sarcopenia includes degenerative muscle weakness and muscular atrophy.
  • the sarcopenia may be degenerative sarcopenia, and refers to a decrease in the muscle mass of skeletal muscle due to a decrease in the number and cross-sectional area of muscle fibers due to various reasons such as aging.
  • the muscular atrophy refers to a disease in which muscles are atrophied, and specifically, a disease in which the muscles of the extremities are gradually atrophied in an almost symmetrical manner, and may include amyotrophic lateral sclerosis or progressive spinal muscular atrophy.
  • it may be prepared in a unit dose form by formulating using a pharmaceutically acceptable carrier, or it may be prepared by internalizing it in a multi-dose container.
  • the pharmaceutically acceptable carriers are those commonly used in formulation, and include lactose, dextrose, sucrose, sorbitol, mannitol, starch, gum acacia, calcium phosphate, alginate, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, water, syrup, methyl cellulose, methyl hydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil, and the like.
  • the pharmaceutical composition of the present invention may further include a lubricant, a wetting agent, a sweetening agent, a flavoring agent, an emulsifying agent, a suspending agent, a preservative, and the like, in addition to the above components.
  • the content of the additive included in the pharmaceutical composition is not particularly limited and may be appropriately adjusted within the content range used for conventional formulation.
  • the pharmaceutical composition is an injectable formulation such as an aqueous solution, suspension, emulsion, etc., pills, capsules, granules, tablets, creams, gels, patches, sprays, ointments, warning agents, lotions, liniments, pastas, and cataplasmas. It may be formulated in the form of one or more external preparations selected from the group consisting of agents.
  • the pharmaceutical composition of the present invention may further include a pharmaceutically acceptable carrier and diluent for formulation.
  • the pharmaceutically acceptable carriers and diluents include starch, sugar, and excipients such as mannitol, fillers and extenders such as calcium phosphate, cellulose derivatives such as carboxymethyl cellulose, hydroxypropyl cellulose, gelatin, alginate, and polyvinyl blood binders such as rolidone; lubricants such as talc, calcium stearate, hydrogenated castor oil and polyethylene glycol; disintegrants such as povidone, crospovidone; surfactants such as polysorbates, cetyl alcohol, and glycerol; does not
  • the pharmaceutically acceptable carrier and diluent may be biologically and physiologically compatible with the subject. Examples of diluents include, but are not limited to, saline, aqueous buffers, solvents and/or dispersion media.
  • the pharmaceutical composition of the present invention may be administered orally or parenterally (eg, intravenously, subcutaneously, intraperitoneally or topically) according to a desired method.
  • parenterally eg, intravenously, subcutaneously, intraperitoneally or topically
  • it may be formulated as tablets, troches, lozenges, aqueous suspensions, oily suspensions, prepared powders, granules, emulsions, hard capsules, soft capsules, syrups or elixirs, and the like.
  • parenteral administration it may be formulated as an injection, suppository, powder for respiratory inhalation, aerosol for spray, ointment, powder for application, oil, cream, and the like.
  • the dosage of the pharmaceutical composition of the present invention depends on the patient's condition and weight, age, sex, health condition, dietary constitution specificity, the nature of the preparation, the degree of disease, the administration time of the composition, administration method, administration period or interval, and excretion rate. , and the range may vary depending on the drug form, and may be appropriately selected by those skilled in the art. For example, it may be in the range of about 0.1 to 10,000 mg/kg, but is not limited now, and may be administered in divided doses from once to several times a day.
  • the pharmaceutical composition may be administered orally or parenterally (eg, intravenously, subcutaneously, intraperitoneally or topically) according to a desired method.
  • the pharmaceutically effective amount and effective dosage of the pharmaceutical composition of the present invention may vary depending on the formulation method, administration method, administration time and / or route of administration of the pharmaceutical composition, and those skilled in the art will It is possible to easily determine and prescribe an effective dosage for treatment.
  • Administration of the pharmaceutical composition of the present invention may be administered once a day, may be administered divided into several times.
  • the present invention provides a health functional food composition for preventing or improving sarcopenia comprising lonafarnib as an active ingredient.
  • the present invention can be generally used as a commonly used food product.
  • the food composition of the present invention can be used as a health functional food.
  • health functional food means a food manufactured and processed using raw materials or ingredients useful for the human body in accordance with the Health Functional Food Act, and "functionality” refers to the structure and function of the human body. It refers to ingestion for the purpose of obtaining useful effects for health purposes such as regulating nutrients or physiological effects.
  • the food composition of the present invention may include conventional food additives, and the suitability as the "food additive” is determined according to the general rules and general test methods of food additives approved by the Ministry of Food and Drug Safety, unless otherwise specified. It is judged according to the standards and standards related to the item.
  • Food Additives Code include, for example, chemical compounds such as ketones, glycine, potassium citrate, nicotinic acid, and cinnamic acid; Mixed preparations such as sodium L-glutamate preparation, noodle-added alkali agent, preservative agent, and tar color agent can be mentioned.
  • the food composition of the present invention may be manufactured and processed in the form of tablets, capsules, powders, granules, liquids, pills, and the like.
  • hard capsules can be prepared by mixing and filling the composition according to the present invention with additives such as excipients in a conventional hard capsule, and the soft capsule is a composition according to the present invention. It can be prepared by mixing with additives such as excipients and filling in capsule bases such as gelatin.
  • the soft capsule formulation may contain a plasticizer such as glycerin or sorbitol, a colorant, a preservative, and the like, if necessary.
  • excipients binders, disintegrants, lubricants, flavoring agents, and the like are described in documents known in the art and include those having the same or similar functions. There is no particular limitation on the type of food, and includes all health functional foods in the ordinary sense.
  • prevention refers to any act of inhibiting or delaying a disease by administering the composition according to the present invention.
  • treatment refers to any action that improves or beneficially changes the symptoms of a disease by administration of the composition according to the present invention.
  • improvement refers to any action that improves the bad state of a disease by administering or ingesting the composition of the present invention to an individual.
  • the present invention provides a method for treating sarcopenia comprising administering the pharmaceutical composition in a pharmaceutically effective amount to an individual other than a human suffering from sarcopenia.
  • the pharmaceutically effective amount is an amount effective for the treatment of a disease, for example, an amount of a composition administered to a subject to be treated, preventing recurrence, alleviating symptoms, inhibiting direct or indirect pathological consequences, Any amount of the composition that prevents metastasis, reduces the rate of progression, alleviates or temporarily ameliorates the condition, or improves the prognosis.
  • DMEM Dulbecco's Modified Eagle's Medium
  • FBS Fetal Bovine Serum
  • penicillin/streptomycin penicillin/streptomycin
  • streptomycin and DMEM (Dulbecco's Modified Eagle's Medium) containing 2% NHS (Normal Horse Serum) was used as a differentiation medium. After polymerization at 37° C.
  • C2C12 cells a passage 4 mouse myoblast cell line with a density of 50% to 60%, were collected using trypsin, and 5000 cells were laid on a 96-well plate coated with gelatin together with a growth medium. Incubated for 24 hours, the medium was replaced with a differentiation medium, and cultured for 48 hours to induce myotube formation. Thereafter, the negative control group and the test group were treated with 150 ⁇ M of dexamethasone to induce atrophy of the root canal.
  • test group was treated with lonafarnib at a concentration of 0.5 ⁇ M to 2 ⁇ M, and 0.1% DMSO was applied to the positive and negative controls.
  • MYH Myosin heavy chain
  • nuclei were stained through the ICC (Immunocytochemistry) method, and the myotube area and fusion index were evaluated.
  • O.C.T optical cutting temperature
  • CSA cross sectional area
  • the amplitude of the compound muscle action potential (hereinafter referred to as CMAP) obtained from stimulation of the sciatic nerve and obtained from TA and GCM It was confirmed that the size decreased after dexamethasone treatment, and the amplitude of lonafarnib increased after 1 ⁇ M or 5 ⁇ M concentration treatment. In the control group not treated with dexamethasone, lonafarnib administration did not affect the amplitude of CMAP. This indicates that lonafarnib is effective in restoring neurophysiological function in an animal model of sarcopenia.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Food Science & Technology (AREA)
  • Neurology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Polymers & Plastics (AREA)
  • Nutrition Science (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne une composition comprenant du lonafarnib en tant que principe actif pour la prévention ou le traitement de la sarcopénie. Dans la présente invention, le lonafarnib est identifié pour présenter un effet d'atténuation de l'atrophie des myotubes formés à partir de myoblastes et, en tant que tel, est fourni comme nouveau médicament pour la prévention, le traitement ou l'atténuation de la sarcopénie.
PCT/KR2022/001591 2021-02-03 2022-01-28 Composition contenant du lonafarnib en tant que principe actif pour la prévention ou le traitement de la sarcopénie Ceased WO2022169226A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR20210015077 2021-02-03
KR10-2021-0015077 2021-02-03
KR1020220012880A KR102729655B1 (ko) 2021-02-03 2022-01-28 로나파르닙을 유효성분으로 포함하는 근감소증의 예방 또는 치료용 조성물
KR10-2022-0012880 2022-01-28

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WO2022169226A1 true WO2022169226A1 (fr) 2022-08-11

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006081444A2 (fr) * 2005-01-28 2006-08-03 The Government Of The Usa As Represented By The Secretary Of The Dept. Of Health And Human Services Inhibiteurs de farnesyl transferase destine a traiter les laminopathies, le vieillissement cellulaire et l'atherosclerose

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006081444A2 (fr) * 2005-01-28 2006-08-03 The Government Of The Usa As Represented By The Secretary Of The Dept. Of Health And Human Services Inhibiteurs de farnesyl transferase destine a traiter les laminopathies, le vieillissement cellulaire et l'atherosclerose

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
CUBRIA MARIA B., SUAREZ SEBASTIAN, MASOUDI AIDIN, OFTADEH RAMIN, KAMALAPATHY PRAMOD, DUBOSE AMANDA, ERDOS MICHAEL R., CABRAL WAYNE: "Evaluation of musculoskeletal phenotype of the G608G progeria mouse model with lonafarnib, pravastatin, and zoledronic acid as treatment groups", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, NATIONAL ACADEMY OF SCIENCES, vol. 117, no. 22, 2 June 2020 (2020-06-02), pages 12029 - 12040, XP055955999, ISSN: 0027-8424, DOI: 10.1073/pnas.1906713117 *
GORDON LESLIE B., KLEINMAN MONICA E., MASSARO JOE, D’AGOSTINO RALPH B., SHAPPELL HEATHER, GERHARD-HERMAN MARIE, SMOOT LESLIE B., G: "Clinical Trial of the Protein Farnesylation Inhibitors Lonafarnib, Pravastatin, and Zoledronic Acid in Children With Hutchinson-Gilford Progeria Syndrome", CIRCULATION, AMERICAN HEART ASSOCIATION, US, vol. 134, no. 2, 12 July 2016 (2016-07-12), US , pages 114 - 125, XP055956002, ISSN: 0009-7322, DOI: 10.1161/CIRCULATIONAHA.116.022188 *
GORDON LESLIE B., KLEINMAN MONICA E., MILLER DAVID T., NEUBERG DONNA S., GIOBBIE-HURDER ANITA, GERHARD-HERMAN MARIE, SMOOT LESLIE : "Clinical trial of a farnesyltransferase inhibitor in children with Hutchinson–Gilford progeria syndrome", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, NATIONAL ACADEMY OF SCIENCES, vol. 109, no. 41, 9 October 2012 (2012-10-09), pages 16666 - 16671, XP055956005, ISSN: 0027-8424, DOI: 10.1073/pnas.1202529109 *
GORDON LESLIE B; CAMPBELL SUSAN E; MASSARO JOSEPH M; D'AGOSTINO SR. RALPH B; KLEINMAN MONICA E; KIERAN MARK W; MOSES MARSHA A: "Survey of plasma proteins in children with progeria pre-therapy and on-therapy with lonafarnib", PEDIATRIC RESEARCH, LIPPINCOTT WILLIAMS & WILKINS, NEW YORK, US, vol. 83, no. 5, 28 February 2018 (2018-02-28), US , pages 982 - 992, XP036968639, ISSN: 0031-3998, DOI: 10.1038/pr.2018.9 *

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