EP3911350A1 - Formulations pharmaceutiques à base d'hormone adrénocorticotropique et leurs procédés de fabrication et d'utilisation - Google Patents

Formulations pharmaceutiques à base d'hormone adrénocorticotropique et leurs procédés de fabrication et d'utilisation

Info

Publication number
EP3911350A1
EP3911350A1 EP20741089.5A EP20741089A EP3911350A1 EP 3911350 A1 EP3911350 A1 EP 3911350A1 EP 20741089 A EP20741089 A EP 20741089A EP 3911350 A1 EP3911350 A1 EP 3911350A1
Authority
EP
European Patent Office
Prior art keywords
pharmaceutical composition
seq
corticotropin
poly
polypeptide
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.)
Withdrawn
Application number
EP20741089.5A
Other languages
German (de)
English (en)
Other versions
EP3911350A4 (fr
Inventor
Dennis Elias Saadeh
Mark L. Baum
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.)
Harrow IP LLC
Original Assignee
Harrow IP LLC
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 US16/250,711 external-priority patent/US11338018B2/en
Application filed by Harrow IP LLC filed Critical Harrow IP LLC
Publication of EP3911350A1 publication Critical patent/EP3911350A1/fr
Publication of EP3911350A4 publication Critical patent/EP3911350A4/fr
Withdrawn legal-status Critical Current

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
    • A61K9/0019—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
    • 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
    • A61K38/33—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin
    • A61K38/35—Corticotropin [ACTH]
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/48—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
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)

Definitions

  • the present invention relates generally to the field of treating autoimmune diseases and associated conditions, and more specifically to corticotropin-based compositions, to methods of using the compositions to treat, mitigate or prevent such diseases, and to methods of preparing such compositions.
  • Rheumatoid arthritis is a progressive autoimmune disease, affecting approximately 2% of the adult population of developed countries (Utsinger, P.D., et al, 1985 Rheumatoid Arthritis, p. 140). This disease is characterized by persistent inflammatory synovitis that causes destruction of cartilage and bone erosion, leading to structural deformities in the peripheral joints.
  • the symptoms associated with rheumatoid arthritis include joint swelling, joint tenderness, inflammation, morning stiffness, and pain, especially upon flexing. Subjects having advanced stages of arthritis suffer from structural damage, including joint destruction with bone erosion.
  • autoimmune diseases generally focuses on reducing immune system activity.
  • Typical current treatments of such diseases include the use various oral or injectable medications, such as animal-derived corticotropin.
  • One commonly used composition utilizing corticotropin is known under the trade name ACTHAR®, available from
  • corticotropin-based treatments are of limited effectiveness in many patients and raise the risk of contamination by infectious agents of a protein nature, which may lead to development of degenerative encephalopathy.
  • products made with animal- derived corticotropin may not conform to the dietary guidelines of vegetarians, Jewish kosher practitioners, or halal practitioners.
  • a pharmaceutical composition comprises, consists essentially of, or consists of corticotropin of a non-animal derivation, wherein the composition is free of gelatin and free of preservatives.
  • the corticotropin used in the composition described herein comprises a quantity of one or several chemically synthesized and/or recombinant polypeptide(s) having the amino acid sequence(s) described herein below.
  • Figure 1 is a graphical diagram showing potency of various exemplary embodiments
  • compositions for up to 180 days are provided.
  • Figure 2 is a graphical diagram showing potency of various exemplary embodiments
  • compositions for up to 180 days are provided.
  • Figure 3 is a graphical diagram showing potency of an exemplary composition for up to 365 days.
  • Figure 4 is a graphical diagram showing potency of various exemplary embodiments
  • compositions for up to 90 days are provided.
  • “About” as used herein means that a number referred to as“about” comprises the recited number plus or minus 1-10% of that recited number. For example,“about” 100 degrees can mean 95-105 degrees or as few as 99-101 degrees, depending on the context. Whenever it appears herein, a numerical range such as“1 to 20” or“1-20” refers to each integer in the given range; i.e., meaning only 1, only 2, only 3, etc., up to and including only 20
  • composition is defined as a chemical or biological compound or substance, or a mixture or combination of two or more such compounds or substances, intended for use in the medical diagnosis, cure, treatment, or prevention of a disease or pathology.
  • Adrenocorticotropic hormone (sometimes abbreviated hereinafter as “ACTH”) and corticotropin are used hereinafter interchangeably and refer to a
  • polypeptide refers to a polymer of amino acid residues.
  • the terms apply to amino acid polymers in which one or more amino acid residue is an artificial chemical mimetic of a corresponding naturally occurring amino acid, as well as to naturally occurring amino acid polymers and non-naturally occurring amino acid polymers.
  • polypeptides consist of more than 10 amino acid residues.
  • recombinant when used in reference to a polypeptide refers to a manipulated polypeptide that is generated in any of various known ways.
  • the formation of recombinant polypeptides may be carried out in specialized vehicles known as vectors, which are used to insert the recombinant polypeptide into a system that supports expression of the gene and translation of messenger RNA. Consequently, when DNA from a foreign source is linked to host sequences that can drive DNA replication and then introduced into a host organism, the foreign DNA is replicated along with the host DNA.
  • a recombinant polypeptide may be identical in every respect to the corresponding polypeptide of the same amino acid sequence that occurs naturally in living organisms.
  • the term“chemically synthesized” when used in reference to a polypeptide refers to synthetic polypeptides that are created by a condensation reaction of the carboxyl group of one amino acid to the amino group of another to form amide bonds linking each successive amino acid. Without being bound by theory, chemical peptide synthesis most commonly starts at the carboxyl end of the peptide (C-terminus), and proceeds toward the amino- terminus (N-terminus).
  • autoimmune disease refers to a pathological physiological state or condition in a human body that arises from abnormal acquired immune system's reactions of the body to substances and/or tissues that are normally present in the body.
  • rheumatic disorder refers to a variety of pathological
  • this term is inclusive of both the disorders primarily caused by autoimmunity (e.g., rheumatoid arthritis, juvenile arthritis, gout, etc.) and the disorders of other origins (e.g., bursitis, osteoarthritis, spondylitis, etc.).
  • autoimmunity e.g., rheumatoid arthritis, juvenile arthritis, gout, etc.
  • the disorders of other origins e.g., bursitis, osteoarthritis, spondylitis, etc.
  • the term“rheumatic disease” encompasses a plethora of disorders that can affect any or many of the body’s systems, but predominantly affect the joints and connective tissues. Many of these disorders tend to be chronic and often people have variable symptoms, experiencing periods of both exacerbation and remission in relation to both the type and severity of these symptoms.
  • Rheumatic diseases are generally classified as inflammatory rheumatism, degenerative rheumatism, extra-articular rheumatism, or collagen diseases.
  • rheumatic diseases include, but are not limited to, osteoarthritis, rheumatoid arthritis, Fibromyalgia, lupus, gout, Juvenile idiopathic arthritis, Infectious arthritis, Psoriatic arthritis, Polymyositis, Bursitis, Ankylosing spondylitis, Reactive arthritis, Scleroderma, and Polymyalgia rheumatic.
  • infantile spasm and“West syndrome” refer interchangeably to a specific type of seizure seen in an epilepsy syndrome of infancy and is characterized by developmental regression and by hypsarrhythmia (chaotic brain waves), which is a specific pattern on electroencephalography chart.
  • the term“Addison’s disease” refers to an endocrine disorder in which the adrenal glands of the sufferer do not produce enough steroid hormones.
  • the term“Cushing’s syndrome” refers to a condition characterized by increased secretion of adrenocorticotropic hormone resulting in multiple negative effects on the health of the patient, e.g., weight gain, hypertension, impaired immunological function, etc.
  • the term“Nelson’s syndrome” refers to a disorder resulting from an adrenalectomy performed for Cushing’s disease, wherein the patient develops macroadenomas that secrete adrenocorticotropic hormone resulting in various severe health problems.
  • the term“lupus” refers to a chronic inflammatory disease that occurs when a person's immune system attacks its own tissues and organs with severe and potentially deadly effects on many body systems, including blood cells, brain, heart, joints, skin, kidneys, and lungs.
  • terapéuticaally effective amount is defined as the amount of a compound or pharmaceutical composition that will elicit the biological or medical response of a tissue, system, animal or human, that is being sought by the researcher, medical doctor or other clinician.
  • potency is defined in accordance with the U.S. Pharmacopeia (USP) and refers to the quantity of an active pharmaceutical component in the composition.
  • USP U.S. Pharmacopeia
  • the potency that is required of the corticotropin compositions described below is not less than 80.0 percent and not more than 125.0 percent of the potency stated on the label in USP corticotropin units.
  • USP unit refers to a unit used to measure the mass of a vitamin or drug based on its expected biological effects. For each substance to which this unit applies, the U.S. Pharmacopeia has determined the biological effect associated with a dose of 1 USP unit. As such, quantities of the substance can be expressed in terms of this standard unit, which, in most cases, is equal to the international unit (IU). For example, 1 USP unit of synthetic porcine corticotropin equals approximately 10 micrograms, which equals 0.01 mg.
  • composition when used to describe a carrier, whether diluent or excipient, is defined as being compatible with the other ingredients of the formulation and not deleterious to the recipient thereof.
  • administration of a composition or“administering a composition” are defined to include the act of providing a compound or pharmaceutical composition of the invention to the subject in need of treatment.
  • compositions are provided for treating, mitigating or preventing various diseases, syndromes and maladies described below.
  • the compositions include corticotropin of a non-animal derivation, completely synthetic in origin and are free of both gelatin and of any preservatives, e.g., are free of such a preservative as phenol. While some of ordinary skill in the art may consider cysteine or its related amino acids (e.g., methionine) as being among preservatives used in some applications, nevertheless, for the purposes of the instant disclosure, cysteine and related amino acids are defined as not being a preservative.
  • compositions of the present invention may contain cysteine or related amino acids such as methionine, or, alternatively, may be cysteine-free and free of amino acids related to cysteine (such as methionine), as desired.
  • cysteine or related amino acids such as methionine
  • the pharmaceutical compositions provided herein avoid the risk of contamination by infectious agents, which may lead to development of degenerative encephalopathy in a subject to which the composition is administered.
  • the pharmaceutical compositions provided herein conform to the dietary guidelines of vegetarians, Jewish kosher practitioners, and halal practitioners.
  • ACTH corticotropin
  • the ACTH employed in the compositions described herein is a fully synthetic, and/or recombinant polypeptide having the same 39-amino acid sequence as the natural polypeptide.
  • synthetic and/or recombinant polypeptides having the first 24, first 17, and first 16 amino acid residues of the 39-amino acid sequence may be prepared and used as described below.
  • the corticotropin of a non-animal derivation used in the pharmaceutical compositions provided herein may include a recombinant polypeptide, a synthetically prepared polypeptide, or both a recombinant polypeptide and a synthetically prepared polypeptide.
  • the corticotropin used in the pharmaceutical compositions provided herein may be a mixture of one or more recombinant and/or synthetically prepared polypeptides of varying lengths (e.g., 39 amino acid residues, 24 amino acid residues, 17 amino acid residues, and 16 amino acid residues).
  • the recombinant polypeptide in the composition is a polypeptide of non-animal derivation that includes the 39-amino acid sequence as set forth in SEQ ID NO: 1 (Synthetic Porcine Corticotropin), as shown below:
  • any one or more of the 24-amino acid polypeptide as set forth in SEQ ID NO: 2, the 16-amino acid polypeptide as set forth in SEQ ID NO: 3, and the 17-amino acid polypeptide as set forth in SEQ ID NO: 4 may be present in the composition in addition to, or, if desired, instead of, the 39-amino acid polypeptide of SEQ ID NO: 1.
  • SEQ ID NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4 are as follows:
  • SEQ ID NO: 2 corresponds to the first 24, the first 16, and the first 17 amino acid residues, respectively, of the synthetically- prepared and/or recombinant polypeptide as set forth in SEQ ID NO: 1, and therefore are also of non-animal derivation.
  • the recombinant polypeptide in the composition may be a polypeptide of non-animal derivation that includes the amino acid sequence as set forth in SEQ ID NO: 5 (Recombinant Human Corticotropin), as shown below: SY SMEHFRWGKPV GKKRRPVKVYPNGAEDES AEAFPLEF (SEQ ID NO: 5).
  • SEQ ID NO: 5 may be used alone or in combination with one or more of SEQ ID NOs: 1-4 in the pharmaceutical compositions provided herein.
  • the quantity of the recombinant polypeptide or chemically synthesized polypeptide in the composition may be between about 40 USP units to about 120 USP units, such as between about 60 USP units to about 100 USP units, 70 USP units to about 90 USP units, for example, about 80 USP units.
  • the pharmaceutical compositions described herein are preservative free, but may further optionally contain various inactive components.
  • inactive components include at least one inert water-soluble viscosity enhancing agent such as dextrose, mannitol, or carboxymethyl cellulose.
  • inert water-soluble viscosity enhancing agent such as dextrose, mannitol, or carboxymethyl cellulose.
  • additional water-soluble viscosity enhancing agent(s) that may be used instead of, or in addition to, dextrose, mannitol and/or
  • carboxymethyl cellulose are cysteine, methyl cellulose, hydroxy ethyl cellulose,
  • hydroxypropyl cellulose non-cross-linked or partially cross-linked polyacrylates.
  • the concentration of the water-soluble viscosity enhancing agent(s) described above, if used in the compositions, may be between about 0.5 mass % and 2.0 about mass % of the total mass of the composition, such as between about 1.0 mass % and about 1.5 mass %, for example, about 1.25 mass %.
  • compositions described herein may further optionally contain additional inactive component(s) that may be used in combination with, or instead of, the inactive component(s) described above.
  • additional inactive component(s) include at least one non-ionic poly(oxyethlene-co-oxypropylene) block copolymer having the following general structure:
  • x is an integer that can have the value of at least 8 and y is an integer that can have the value of at least 38.
  • P407 poly(ethylene glycol)-block-poly (propylene glycol)-block- poly(ethylene glycol) available from Sigma- Aldrich Corp. of St.
  • thermoreversible gel of the compositions of the present invention are, for example, the products of the PLURONIC® family, KOLLIPHOR® family (the trade names are also owned by BASF) or SYNPERONICS® family (Croda International pic). Any polymer of POLOXAMER®, PLURONIC®, KOLLIPHOR® or SYNPERONICS® family that is used may contain any portion that is cross-linked.
  • the concentration of the non-ionic poly(oxyethlene-co-oxypropylene) block copolymer(s) described above, if used in the compositions, may be between about 0.1 mass % and about 1.0 mass % of the total mass of the composition, for example, between about 0.1 mass % and about 2.0 mass %. In various embodiments the concentration of non-ionic poly(oxyethlene-co-oxypropylene) block copolymer(s) is about 0.3 mass %, about 0.5 mass %, about 0.7 mass %, or about 1.0 mass %.
  • Additional inactive component(s) include, but are not limited to, polyoxyethylene sorbitan monolaurates, polyoxyethylene sorbitan monopalmitates, polyoxyethylene sorbitan monostearates, and polyoxyethylene sorbitan monooleates.
  • methods for fabricating the above-described pharmaceutical articles are provided. A one-batch formulation method may be used, where the components of the pharmaceutical formulation are combined in single container; the components may be added to the container simultaneously or consecutively.
  • the resulting product may then be adapted for administration by a suitable route (e.g by intramuscular or subcutaneous injection), and may then be prescribed and given to a patient for treating, mitigating or preventing autoimmune diseases, such as rheumatoid arthritis, as well as associated syndromes, symptoms, pathologies, maladies, or conditions.
  • a suitable route e.g by intramuscular or subcutaneous injection
  • mitigating or preventing autoimmune diseases such as rheumatoid arthritis
  • associated syndromes symptoms, pathologies, maladies, or conditions.
  • compositions if an amino acid is used in compositions, the choice and concentration of the amino acid may be consequential. For example, in some experiments cysteine was used at a concentration of about lmg/ml. Such compositions lacked sufficient potency. On the other hand, using methionine instead of, or in addition to, cysteine, combined with increased concentration of the amino acid(s) up to about mg/ml can improved the potency substantially and to bring it to desirable level. Using mannitol has also proved to be beneficial for increasing the potency.
  • the above described pharmaceutical formulations may be incorporated within microparticles.
  • the microparticles may be substantially spherical particles (shells) fabricated of a water-soluble biodegradable polymer defining a space therein, which space is to be filled with the pharmaceutical formulation.
  • the microparticles represent the structures where the water-soluble biodegradable polymer envelops the formulation securely encapsulating the latter and not allowing the formulation to prematurely escape or to leak out.
  • the formulation-filled microparticles can be manufactured according to methods and techniques known to those having ordinary skill in the art.
  • the size of microparticles may be typically less than about 100 pm in diameter, and the exemplary water soluble polymer to be used to manufacture the shells may be, without limitations, any of poly(lactic acid-co- gly colic acid), poly(lactic acid), poly(glycolic acid), poly(caprolactone),
  • poly(hydroxybutyrate) and blends thereof poly(lactic acid-co- gly colic acid) can be used to form the shells, with the 50:50 (mass) ratio between the units derived of lactic and glycolic acids.
  • Other acceptable ratios between the lactic and glycolic acid portions may be 65:35, 75:25 and 85: 15.
  • poly(lactic acid-co-gly colic acid) may select a different ratio, if desired.
  • the inherent viscosities (i.e., the ratio of the natural logarithm of the relative viscosity to the mass concentration of the polymer) of the polymer solutions used to form the shells may be between about 0.15 dL/g and about 1.20 dL/g, such as between about 0.15 dL/g and 0.25 dL/g, or of the following ranges: 0.26-0.54, 0.55-0.75, 0.62-0.65, 0.65-0.85, 0.76-0.94 and 0.95-1.20 dL/g.
  • microparticles When the above described microparticles have been fabricated, they can then be administered to a patient in need of the medication by conventional methods described herein, such as by injection.
  • kits include sealed containers approved for the storage of pharmaceutical compositions, and the above- described pharmaceutical composition. An instruction for the use of the composition and the information about the composition are to be included in the kit.
  • a pharmaceutical composition can be prepared as described below.
  • the following products can be used in the amounts and concentrations specified:
  • the stated quantities of cysteine and mannitol may be mixed with about 30% of water (about 30 mL) followed by adding ACTH to the solution which can then be filtered into a sterile 100 mL vial through a 0.22 micron Teflon filter. Finally, the stated amount of sodium carboxymethyl cellulose may be added to the vial followed by agitation to achieve dispersion. Alternatively, the dispersion may be achieved by using the method of“transferring from syringe to syringe” known to those having ordinary skill in the art.
  • the product so obtained can then be checked for the level of pH, and if this level is outside the range of about 4.5 to about 7.0, it can be adjusted by adding, dropwise, a quantity of hydrochloric acid that is necessary to achieve such an adjustment.
  • the product can then be transferred into 1 mL sterile amber serum vials with about 0.2 mL overfill.
  • a pharmaceutical composition was prepared as described in Example 1 using the same components in the same quantities and employing the same compounding procedure, except that cysteine was replaced by about 0.298 g of powdered 0.3% methionine.
  • a pharmaceutical composition was prepared as described below. The following products were used in the amounts and concentrations specified:
  • the stated amount of sodium carboxymethyl cellulose was added to the vial followed by agitation to achieve dispersion.
  • the dispersion may be achieved by using the method of“transferring from syringe to syringe” known to those having ordinary skill in the art.
  • the product can then be transferred into 1 mL sterile amber serum vials with about 0.2 mL overfill.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne des compositions pharmaceutiques permettant de traiter ou de prévenir des maladies auto-immunes et des états associés ou d'en atténuer les symptômes. L'invention concerne en outre des procédés de fabrication et d'utilisation de ces compositions.
EP20741089.5A 2019-01-17 2020-01-14 Formulations pharmaceutiques à base d'hormone adrénocorticotropique et leurs procédés de fabrication et d'utilisation Withdrawn EP3911350A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US16/250,711 US11338018B2 (en) 2016-12-19 2019-01-17 Adrenocorticotropic hormone-based pharmaceutical formulations and methods for fabricating and using thereof
PCT/US2020/013543 WO2020150262A1 (fr) 2019-01-17 2020-01-14 Formulations pharmaceutiques à base d'hormone adrénocorticotropique et leurs procédés de fabrication et d'utilisation

Publications (2)

Publication Number Publication Date
EP3911350A1 true EP3911350A1 (fr) 2021-11-24
EP3911350A4 EP3911350A4 (fr) 2022-12-14

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EP20741089.5A Withdrawn EP3911350A4 (fr) 2019-01-17 2020-01-14 Formulations pharmaceutiques à base d'hormone adrénocorticotropique et leurs procédés de fabrication et d'utilisation

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WO (1) WO2020150262A1 (fr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11338018B2 (en) 2016-12-19 2022-05-24 Harrow Ip, Llc Adrenocorticotropic hormone-based pharmaceutical formulations and methods for fabricating and using thereof

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090175821A1 (en) * 1999-05-17 2009-07-09 Bridon Dominique P Modified therapeutic peptides with extended half-lives in vivo
EP2081587A2 (fr) * 2006-10-18 2009-07-29 Research Development Foundation Thérapies alpha-MSH destinées au traitement de maladies auto-immunes
US20140294923A1 (en) * 2013-02-20 2014-10-02 Questcor Pharmaceuticals, Inc. Acth for treatment of migraine headache
EP2968475A2 (fr) * 2013-03-14 2016-01-20 Questcor Pharmaceuticals, Inc. Acth dans le traitement du syndrome de détresse respiratoire aiguë
GB201315335D0 (en) * 2013-08-29 2013-10-09 Of Singapore Amino diacids containing peptide modifiers
US20180169191A1 (en) * 2016-12-19 2018-06-21 Eton Pharmaceuticals, Inc. Adrenocorticotropic hormone-based pharmaceutical formulations and methods for fabricating and using thereof

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WO2020150262A1 (fr) 2020-07-23

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