Method for treatment of diseases related to masp-2-dependent activation of complement (versions)

FIELD: biotechnologies.

SUBSTANCE: medicinal agent for inhibition of MASP-2-dependent complement is an agent containing an antibody or its fragment, bound with a full-size polypeptide MASP-2, but not bound with a MASP-2 N-terminal fragment containing CUBI-EGF-CUBII domains and not bound with a MASP-2 C-terminal fragment, containing of CCPII-SP domains.

EFFECT: invention makes it possible to selectively inhibit MASP-2-dependent activation of complement, at the same time leaving Clq-dependent classic path of complement activation as functionally unaffected.

9 cl, 39 dwg, 7 tbl, 31 ex

 

The text descriptions are given in facsimile form.

1. Agent, inhibiting MASP-2, designed for use as a drug, selectively inhibiting MASP-2-dependent activation of the complement, while leaving functionally unaffected Clq-dependent classical pathway of activation of complement, where the said agent comprises an antibody or fragment to bind to the full-length polypeptide MASP-2, which is a sequence of SEQ ID NO:6, but does not bind to MASP-2 N-terminal fragment consisting of CUBI-EGF-CUBII domain and does not bind to MASP-2 C-terminal fragment consisting of CCPII-SP domains.

2. The agent according to claim 1, where the agent, inhibiting MASP-2, specifically binds to the polypeptide comprising the sequence of SEQ ID NO:6 with an affinity of at least 10 times greater than in the case of linking an excellent antigen in the complement system.

3. The agent according to claim 1, where the agent, inhibiting MASP-2, representing the antibody or its fragment that specific image associated with a segment of the sequence SEQ ID NO:6, for example, where the antibody or fragment is a monoclonal or polyclonal, or recombinant antibody, or where the antibody has reduced effector function, or dianthicola presents chimeric, humanized or human antibody, or where the antibody obtained in MASP-2 insufficient transgenic animal cells.

4. A method of inhibiting MASP-2-dependent activation of the complement of a mammal object, suffering from indirect MASP-2-dependent complement, which includes an introduction to the mammalian subject a quantity of an agent that inhibits MASP-2, effective for the selective suppression of MASP-2 dependent activation of complement, while leaving functionally unaffected Clq-dependent classical pathway of activation of complement, where the agent, inhibiting MASP-2, is an antibody or fragment to bind to the full-length polypeptide MASP-2, which is a sequence of SEQ ID NO:6, but does not bind to MASP-2 The N-terminal fragment consisting of CUBI-EGF-CUBII domains, and does not bind to MASP-2 C-terminal fragment consisting of CCPII-SP domains.

5. The method according to claim 4, where the agent, inhibiting MASP-2 specifically binds to a polypeptide comprising the sequence of SEQ ID NO:6.

6. The method according to claim 4, where the agent, inhibiting MASP-2, is an antibody or fragment that specifically binds to a segment of the sequence SEQ ID NO:6, for example, where the antibody or fragment is a monoclonal, or where the antibody presents chimeric, GU is Anisimovna or human antibody or where the antibody obtained in MASP-2 insufficient transgenic animal cells.

7. The method according to claim 4, comprising the administration to a mammal object of the amount of agent that inhibits MASP-2, effective for:
(i) the treating facility, suffering from a MASP-2-dependent complement-mediated vascular insufficiency, including the introduction amount of an agent that inhibits MASP-2, effective to inhibit MASP-2-dependent activation of complement, where vascular insufficiency preferably belongs to the group of the following diseases: cardiovascular disease, cerebrovascular insufficiency, peripheral (e.g., musculoskeletal) vascular insufficiency, renovaskulyarnoy failure, mesenterina/enteric vascular failure, revascularization (restoration of vessels in any tissue or organ) transplantation or/and reimplantations, vasculitis, disease shenleyn's disease (Henoch-Schonlein purpura), nephritis, vasculitis, due to systemic lupus erythematosus, vasculitis, due to rheumatoid arthritis, immune complex vasculitis, Takayasu's arteritis (sickness absence of pulse), dilated cardiomyopathy, diabetic angiopathy, Kawasaki syndrome (syndrome T4 - hyperlattices, Takayasu), venous air embolism (VDE), and restenosis (re-narrowing of the issue is the ETA of any authority after its enlargement surgery) due to the introduction of the stent, rotational atherectomy and percutaneous transluminal coronary angioplasty (RTSA); or
(ii) treatment of the object, suffering from a MASP-2-dependent complement mediated condition associated with ischemia-reperfusion injury, preferably ischemia and reperfusion injury associated with aneurysm repair ports, extracorporeal circulation, vascular reanastomosis due to organ transplantation or/and re limbs/fingers, stroke, myocardial infarction and hemodynamic resuscitation after a shock or/and surgical intervention;
(iii) the treatment or/and prevention of atherosclerosis in monitoring object when appropriate, or
(iv) treatment of the object, suffering from a MASP-2-dependent complement-mediated disease caused by inflammatory gastrointestinal disorders, preferably gastrointestinal disturbance selected from the group consisting of pancreatitis, granulomatous disease (Crohn's disease), ulcerative colitis, irritable bowel syndrome, and diverticulitis; or
(v) treatment of the object, suffering from a MASP-2-dependent complement-mediated pulmonary disease, preferably pulmonary disease is selected from the group consisting of the following: acute respiratory distress syndrome, transfusion-induced lung damage (TRALI), acute ischemic-reperfusion pulmonary disease, chronic obstructive pulmonary disease, asthma, non-infectious necrotic Wegener (Wegener's granulomatosis), disease glomerular basement membrane disease Goodpasture)syndrome meconial aspiration syndrome obliterating bronchiolitis, idiopathic pulmonary fibrosis, acute lung injury due to burns, nicardipine pulmonary edema, transfusion-induced depression of breath and emphysema; or
(vi) treatment of the object, which was, is or will be the procedure for in vitro reperfusion, preferably procedure extracorporeal reperfusion selected from the group consisting of the following diseases: hemodialysis, plasmapheresis, leukocytopenia, extracorporeal membrane oxygenator (ECMO), heparin-induced extracorporeal membrane oxygenation with precipitation of LDL - HELP), and extracorporeal circulation (SRV); or
(vii) treatment of the object, suffering from a MASP-2-dependent complement-mediated skeletal muscle disease, preferably musculoskeletal disease selected from the group consisting of the following diseases: osteoarthritis, rheumatoid arthritis, of still's disease (a form of rheumatoid arthritis in children), gout, neurogenic arthropathy, psoriatic arthritis, spondyle ropati, fragmentary arthropathy, muscular dystrophy, and systemic lupus erythematosus (SLE); or
(viii) treatment of the object, suffering from a MASP-2-dependent complement-mediated renal disease, preferably renal disease selected from the group consisting of the following diseases: mesangiocapillary glomerulonephritis, membranous glomerulonephritis, membranosa-proliferative glomerulonephritis (mesangiocapillary glomerulitis), acute post-infectious glomerulitis (poststreptococcal glomerulitis), cryoglobulinaemic glomerulonephritis, lupus nephritis, nephritis as a complication of disease Shenleyn's disease and Berger disease (IgA nephropathy); or
(ix) the treating facility, suffering from a MASP-2-dependent complement-mediated skin disease, preferably a skin disease selected from the following groups of diseases: psoriasis, autoimmune bullous dermatitis, eosinophilic interstitial edema, bullous pemphigoid acquired bullous bullosa, herpes pregnant, damage due to thermal and chemical burns; or
(x) the treatment of the object, which was, is or will be the procedure for transplantation of organs or tissues, preferably the transplant procedure selected from the group consisting of allotransplantation organs, xenotransplantation of organs, and per the cages tissues: or
(xi) the treating facility, suffering from a MASP-2-dependent complement mediated condition associated with disorders or damage to the nervous system, preferably a violation of or damage to the nervous system selected from the following groups of diseases: multiple sclerosis, progressive myasthenia gravis, Huntington's disease, amyotrophic lateral sclerosis, infectious polyneuritis (syndrome Guillain Barre), post-traumatic reperfusion, reborn ROM, cerebral trauma, Parkinson's disease, Alzheimer's disease, syndrome, Miller-Fisher, cerebral trauma and/or hemorrhage, demyelinization (destruction of the myelin nerve fiber layer) and meningitis, or
(xii) treatment of the object of observation, suffering from a MASP-2-dependent complement-mediated blood diseases, preferably a blood disorder selected from the group consisting of the following diseases: sepsis, severe sepsis complications, septic shock syndrome, systemic inflammatory response syndrome of acute respiratory failure as a concomitant disease with sepsis, a syndrome of systemic inflammatory response, hemorrhagic collapse, hemolytic anemia, autoimmune thrombocytopenic greengourmet syndrome and hemolytic uremia; or
(xiii) treatment of the object of observation, suffering from a MASP-2-dependent compleme is the indirect urogenital disease, preferably urogenital disease selected from the group of the following diseases: syndrome, painful bladder, overactive bladder, bacterially cystitis, interstitial cystitis, infertility, placental dysfunction (failure) and spontaneous abortion and pre-eclampsia (late toxicosis of pregnant women); or
(xiv) treatment of the object of observation, suffering from a MASP-2-dependent complement-mediated diabetes no inclination to obesity (diabetes mellitus type 1 or insulin-dependent diabetes mellitus or/and complications due to type 1 diabetes or type 2 (attack in adults), preferably where the complication associated with type 1 diabetes or type 2 is selected from the group consisting of angiopathy, neuropathy, and retinopathy; or
(xv) the treatment of the object of observation, which was, is or will be chemotherapy or/and radiotherapy; or
(xvi) the treating facility, suffering from malignant disease; or
(xii) the treating facility, suffering from endocrine diseases, preferably endocrine disease selected from the group consisting of the following medical conditions: Hashimoto's thyroiditis, stress, symptoms of anxiety, hormonal disorders affecting the regulated secretion of prolactin, growth of tumors Il the other factors, provoked insulin-dependent States and adrenocorticotropic hormone from the pituitary gland; or
(xiii) the treating facility, suffering from a complement-mediated ophthalmologic disease, preferably where the ophthalmological disease is age-related macular degeneration.

8. Composition for inhibiting MASP-2-dependent activation of complement, comprising a therapeutically effective amount of an agent that inhibits MASP-2 disclosed in claims 1, 2 or 3 and a pharmaceutically acceptable carrier.

9. Method for the production of medicaments for use in the inhibition effects of MASP-2-dependent activation of the complement of a living mammal object, suffering from indirect MASP-2-dependent complement, comprising combining a therapeutically effective amount of an agent that inhibits MASP-2 disclosed in claims 1, 2 or 3, in a pharmaceutical carrier.



 

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