HRP20201764T1 - Upotreba inhibitora miostatina i kombinacijske terapije - Google Patents
Upotreba inhibitora miostatina i kombinacijske terapije Download PDFInfo
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- HRP20201764T1 HRP20201764T1 HRP20201764TT HRP20201764T HRP20201764T1 HR P20201764 T1 HRP20201764 T1 HR P20201764T1 HR P20201764T T HRP20201764T T HR P20201764TT HR P20201764 T HRP20201764 T HR P20201764T HR P20201764 T1 HRP20201764 T1 HR P20201764T1
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- myostatin
- smn
- inhibitor
- myostatin inhibitor
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- 102000004472 Myostatin Human genes 0.000 title claims 37
- 108010056852 Myostatin Proteins 0.000 title claims 37
- 239000003112 inhibitor Substances 0.000 title claims 28
- 238000002648 combination therapy Methods 0.000 title 1
- 102100021947 Survival motor neuron protein Human genes 0.000 claims 18
- 208000002320 spinal muscular atrophy Diseases 0.000 claims 14
- 239000000427 antigen Substances 0.000 claims 7
- 102000036639 antigens Human genes 0.000 claims 7
- 108091007433 antigens Proteins 0.000 claims 7
- 125000003275 alpha amino acid group Chemical group 0.000 claims 4
- 239000003623 enhancer Substances 0.000 claims 4
- 238000012153 long-term therapy Methods 0.000 claims 4
- 238000002560 therapeutic procedure Methods 0.000 claims 4
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 2
- 101150113275 Smn gene Proteins 0.000 claims 2
- 230000004913 activation Effects 0.000 claims 2
- 230000003698 anagen phase Effects 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 230000002401 inhibitory effect Effects 0.000 claims 2
- 238000012423 maintenance Methods 0.000 claims 2
- 239000003607 modifier Substances 0.000 claims 2
- 210000003205 muscle Anatomy 0.000 claims 2
- 229940124272 protein stabilizer Drugs 0.000 claims 2
- 230000014616 translation Effects 0.000 claims 2
- 108020005544 Antisense RNA Proteins 0.000 claims 1
- 206010061818 Disease progression Diseases 0.000 claims 1
- 206010028289 Muscle atrophy Diseases 0.000 claims 1
- 239000003184 complementary RNA Substances 0.000 claims 1
- 230000008878 coupling Effects 0.000 claims 1
- 238000010168 coupling process Methods 0.000 claims 1
- 238000005859 coupling reaction Methods 0.000 claims 1
- 230000008021 deposition Effects 0.000 claims 1
- 230000005750 disease progression Effects 0.000 claims 1
- 238000001415 gene therapy Methods 0.000 claims 1
- 230000002068 genetic effect Effects 0.000 claims 1
- 238000001802 infusion Methods 0.000 claims 1
- 238000007918 intramuscular administration Methods 0.000 claims 1
- 238000010253 intravenous injection Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 230000000116 mitigating effect Effects 0.000 claims 1
- 230000020763 muscle atrophy Effects 0.000 claims 1
- 201000000585 muscular atrophy Diseases 0.000 claims 1
- 210000002569 neuron Anatomy 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 150000003384 small molecules Chemical class 0.000 claims 1
- 238000010254 subcutaneous injection Methods 0.000 claims 1
- 239000007929 subcutaneous injection Substances 0.000 claims 1
- 238000013518 transcription Methods 0.000 claims 1
- 230000035897 transcription Effects 0.000 claims 1
- 230000002103 transcriptional effect Effects 0.000 claims 1
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- A—HUMAN NECESSITIES
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- A61K31/7088—Compounds having three or more nucleosides or nucleotides
- A61K31/7105—Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
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- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/50—Pyridazines; Hydrogenated pyridazines
- A61K31/501—Pyridazines; Hydrogenated pyridazines not condensed and containing further heterocyclic rings
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- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
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- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
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- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
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- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
- C12N15/113—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
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- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
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- C07K2317/567—Framework region [FR]
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- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
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Claims (15)
1. Inhibitor miostatina koji je selektivan za miostatin za upotrebu u postupku liječenja spinalne mišićne atrofije (SMA) kod subjekta,
pri čemu se selektivni inhibitor miostatina daje u količini efikasnoj za liječenje SMA,
pri čemu je subjekt: (i) na terapiji korektorom za SMN ili je liječen terapijom sa korektorom SMN tijekom šest mjeseci inhibitora miostatina; i (ii) u fazi rasta i/ili ima potrebu za primanjem dugotrajne terapije, gdje dugotrajna terapija po potrebi uključuje održavanje SMA tijekom života, pri čemu je selektivni inhibitor miostatina:
(a) antitijelo, ili njegov dio za vezivanje antigena, koji vezuje pro- ili latentni miostatin, time inhibirajući aktivaciju miostatina; ili
(b) antitijelo, ili njegov dio za vezivanje antigena, koji vezuje zreli miostatin;
i gdje terapija sa korektorom SMN obuhvaća:
i) modifikator spajanja;
ii) zamjenu SMN gena ili genetsku terapiju;
iii) transkripcijski pojačivač za SMN;
iv) pojačivač translacije SMN proteina; ili,
v) stabilizator SMN proteina.
2. Inhibitor miostatina za upotrebu prema zahtjevu 1, gdje je subjekt pedijatrijski subjekt ili mlada odrasla osoba koja još raste i anabolički je aktivna.
3. Inhibitor miostatina za upotrebu prema zahtjevu 1(a), gdje se antitijelo, ili njegov dio za vezivanje antigena, vezuje za prodomen miostatina.
4. Inhibitor miostatina za upotrebu prema zahtjevu 1(a), gdje se antiijtelo, ili njegov dio za vezivanje antigena, ne vezuje za zreli miostatin koji nije povezan sa pro- ili latentnim miostatinom.
5. Inhibitor miostatina za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu korektor SMN je antisens RNK ili mala molekula.
6. Inhibitor miostatina za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu subjekt ima SMA koja ograničava kretanje ili SMA koja ne ograničava kretanje.
7. Inhibitor miostatina za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu subjekt ima dijagnozu tip I SMA, tip II SMA, ili tip III SMA.
8. Inhibitor miostatina za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu subjekt ima osnovni rezultat ≤ 65 Proširene Hammersmith-ove Funkcionalne Motorne Skale prije davanja inhibitora miostatina.
9. Inhibitor miostatina za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu količina efikasna za liječenje SMA je količina koja je efikasna za:
a) odlaganje ili ublažavanje mišićne atrofije;
b) odlaganje gubitka α-motornih neurona;
c) sprječavanje ili odlaganje ekspresije nezrelih mišićnih markera;
d) sprječavanje, ublažavanje ili odlaganje intramuskularnih naslaga masti naznačeno sa masnom zamjenom mišićnog tkiva;
e) povećanje rezultata Proširene Hammersmith-ove Funkcionalne Motorne Skale za ≥ 1 bodova u usporedbi sa netretiranom kontrolnom grupom, ili, za ≥ 1 bodova od osnovnog mjereno prije tretmana;
f) odlaganje napredovanja bolesti prema Proširenoj Hammersmith-ovoj Funkcionalnoj Motornoj Skali tijekom perioda od 12 mjeseci, 24 mjeseca ili 36 mjeseci;
g) povećanje CHOP INTEND rezultata za ≥ 1 bodova u usporedbi sa netretiranom kontrolom; i/ili,
h) povećanje MFM-32 rezultata za najmanje 1 bod u usporedbi sa netretiranom kontrolom.
10. Inhibitor miostatina za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu je inhibitor namijenjen za davanje preko intravenozne injekcije ili infuzije ili preko subkutanozne injekcije.
11. Inhibitor miostatina za upotrebu prema bilo kojem od prethodnih zahtjeva, gdje je inhibitor antitijelo, ili njegov dio za vezivanje antigena, koji:
(a) sadrži šest područja za određivanje komplementarnosti (CDRs): CDRH1, CDRH2, CDRH3, CDRL1, CDRL2, i CDRL3, gdje:
CDRH1 sadrži sekvencu kao što je predstavljena u SEQ ID NO: 1 ili 2;
CDRH2 sadrži sekvencu kao što je predstavljena u SEQ ID NOs: 4 ili 5;
CDRH3 sadrži sekvencu kao što je predstavljena u SEQ ID NO: 10;
CDRL1 sadrži sekvencu kao što je predstavljena u SEQ ID NOs: 12 ili 13;
CDRL2 sadrži sekvencu kao što je predstavljena u SEQ ID NOs: 18 ili 19; i
CDRL3 sadrži sekvencu kao što je predstavljena u SEQ ID NO: 22;
(b) sadrži varijabilnu regiju teškog lanca koji se sastoji iz aminokiselinske sekvence SEQ ID NO:25 i varijabilnu regiju lakog lanca koji se sastoji iz aminokiselinske sekvence SEQ ID NO:31; ili
(c) sadrži teški lanac koji se sastoji iz aminokiselinske sekvence SEQ ID NO:50 i laki lanac koji se sastoji iz aminokiselinske sekvence SEQ ID NO:51.
12. Inhibitor miostatina koji je selektivan za miostatin, korektor SMN, za upotrebu u postupku liječenja spinalne mišićne atrofije (SMA) kod subjekta, pri čemu je subjekt u fazi rasta i/ili ima potrebu za primanjem dugotrajne terapije, pri čemu dugotrajna terapija po potrebi uključuje održavanje SMA tijekom života, pri čemu je selektivni inhibitor miostatina:
(a) antitijelo, ili njegov dio za vezivanje antigena, koji vezuje pro- ili latentni miostatin, time inhibirajući aktivaciju miostatina; ili
(b) antitijelo, ili njegov dio za vezivanje antigena, koji vezuje zreli miostatin, i gdje korektor SMN sadrži:
i) modifikator spajanja
ii) sredstvo za zamjenu SMN gena ili sredstvo za genetsku terapiju;
iii) pojačivač SMN transkripcije;
iv) pojačivač translacije SMN proteina; ili,
v) stabilizator SMN proteina.
13. Inhibitor miostatina i korektor SMN za upotrebu prema zahtjevu 12, pri čemu inhibitor miostatina i korektor SMN su za konkurentno ili serijsko davanje subjektu.
14. Inhibitor miostatina i korektor SMN za upotrebu prema zahtjevu 12 ili zahtjevu 13, pri čemu subjekt prima korektor SMN i inhibitor miostatina tijekom šest mjeseci jednog od drugog.
15. Inhibitor miostatina i korektor SMN za upotrebu prema bilo kojem od zahtjeva 12-14 gdje je subjekt kao što je definirano u zahtjevu 2 ili 6-8; pri čemu je selektivni inhibitor miostatina kao što je definirano u bilo kojem od zahtjeva 3, 4 ili 11; pri čemu korektor SMN je kao što je definirano u zahtjevu 5; pri čemu je selektivni inhibitor miostatina za davanje u količini koja je efikasna za liječenje SMA kako je definirano u zahtjevu 9; i/ili gdje selektivni inhibitor miostatina je za davanje kao što je definirano u zahtjevu 10.
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201662349596P | 2016-06-13 | 2016-06-13 | |
US201762470157P | 2017-03-10 | 2017-03-10 | |
US201762486934P | 2017-04-18 | 2017-04-18 | |
US201762511702P | 2017-05-26 | 2017-05-26 | |
US201762512254P | 2017-05-30 | 2017-05-30 | |
PCT/US2017/037332 WO2017218592A1 (en) | 2016-06-13 | 2017-06-13 | Use of myostatin inhibitors and combination therapies |
EP17732001.7A EP3368069B1 (en) | 2016-06-13 | 2017-06-13 | Use of myostatin inhibitors and combination therapies |
Publications (1)
Publication Number | Publication Date |
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HRP20201764T1 true HRP20201764T1 (hr) | 2020-12-25 |
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HRP20201764TT HRP20201764T1 (hr) | 2016-06-13 | 2020-10-30 | Upotreba inhibitora miostatina i kombinacijske terapije |
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Country | Link |
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US (2) | US10946036B2 (hr) |
EP (3) | EP4218804A3 (hr) |
JP (4) | JP6823167B2 (hr) |
KR (4) | KR20230028813A (hr) |
AU (3) | AU2017283546C1 (hr) |
CL (1) | CL2018003588A1 (hr) |
CY (1) | CY1123678T1 (hr) |
DK (1) | DK3368069T3 (hr) |
ES (1) | ES2830440T3 (hr) |
HR (1) | HRP20201764T1 (hr) |
HU (1) | HUE051480T2 (hr) |
IL (2) | IL301468A (hr) |
LT (1) | LT3368069T (hr) |
MY (1) | MY185614A (hr) |
PE (1) | PE20190205A1 (hr) |
PT (1) | PT3368069T (hr) |
RS (1) | RS61090B1 (hr) |
SI (1) | SI3368069T1 (hr) |
WO (1) | WO2017218592A1 (hr) |
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US11046784B2 (en) | 2006-03-31 | 2021-06-29 | Chugai Seiyaku Kabushiki Kaisha | Methods for controlling blood pharmacokinetics of antibodies |
SI2202245T1 (sl) | 2007-09-26 | 2016-10-28 | Chugai Seiyaku Kabushiki Kaisha | Postopek modificiranja izoelektrične točke protitelesa preko aminokislinske substitucije v CDR |
CN107488228A (zh) | 2008-04-11 | 2017-12-19 | 中外制药株式会社 | 与多个分子的抗原反复结合的抗原结合分子 |
RU2658504C9 (ru) | 2010-11-30 | 2018-08-21 | Чугаи Сейяку Кабусики Кайся | Антигенсвязывающая молекула, способная многократно связываться с множеством антигенных молекул |
WO2014030750A1 (ja) | 2012-08-24 | 2014-02-27 | 中外製薬株式会社 | マウスFcγRII特異的Fc抗体 |
EP3783017A1 (en) | 2013-04-02 | 2021-02-24 | Chugai Seiyaku Kabushiki Kaisha | Fc region variant |
JP6706617B2 (ja) | 2014-11-06 | 2020-06-10 | スカラー ロック インコーポレイテッドScholar Rock,Inc. | 抗プロ/潜在型−ミオスタチン抗体およびその使用 |
EP3240804A4 (en) | 2014-12-19 | 2019-01-09 | Chugai Seiyaku Kabushiki Kaisha | ANTI-MYOSTATIN ANTIBODIES, POLYPEPTIDES WITH DEVIANT FC REGIONS AND METHOD OF USE |
EP3816179A3 (en) | 2015-02-05 | 2021-08-04 | Chugai Seiyaku Kabushiki Kaisha | Fc region variant comprising a modified fcrn-binding domain |
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