HRP20230308T1 - Liječenje metaboličkih bolesti putem inhibiranja aktivacije miostatina - Google Patents
Liječenje metaboličkih bolesti putem inhibiranja aktivacije miostatina Download PDFInfo
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- 108010056852 Myostatin Proteins 0.000 title claims 10
- 208000030159 metabolic disease Diseases 0.000 title claims 7
- 230000004913 activation Effects 0.000 title claims 2
- 102000004472 Myostatin Human genes 0.000 title 1
- 230000002401 inhibitory effect Effects 0.000 title 1
- 239000012634 fragment Substances 0.000 claims 14
- 239000000427 antigen Substances 0.000 claims 13
- 102000036639 antigens Human genes 0.000 claims 13
- 108091007433 antigens Proteins 0.000 claims 13
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Claims (19)
1. Pripravak koji sadrži inhibitor miostatina gdje on predstavlja protutijelo ili njegov fragment koji veže antigen, naznačen time, da je za uporabu kao lijek u liječenju metaboličke bolesti kod ljudskog pojedinca, pri čemu postupak obuhvaća sljedeće korake:
odabir ljudskog pojedinca koji boluje od metaboličke bolesti; i
primjena na ljudskom pojedincu pripravka koji sadrži učinkovitu količinu protutijela, ili njegovog fragmenta koji veže antigen;
pri čemu metabolička bolest je pretilost, metabolički sindrom, nealkoholni steatohepatitis (NASH), nealkoholna bolest masne jetre (NAFDL) i/ili dijabetes;
dok je ljudski pojedinac na dijeti sa smanjenim unosom kalorija.
2. Pripravak za uporabu prema patentnom zahtjevu 1, naznačen time, da se protutijelo ili njegov fragment koji veže antigen specifično veže na pro/latentni miostatin.
3. Pripravak za uporabu prema patentnom zahtjevu 2, naznačen time, da se protutijelo ili njegov fragment koji veže antigen specifično veže na pro/latentni miostatin i blokira aktivaciju zrelog miostatina.
4. Pripravak za uporabu prema patentnom zahtjevu 2 ili 3, naznačen time, da se protutijelo ili njegov fragment koji veže antigen specifično veže na pro/latentni miostatin i blokira oslobađanje zrelog miostatina.
5. Pripravak za uporabu prema patentnom zahtjevu 1, naznačen time, da protutijelo ili njegov fragment veže zreli miostatin.
6. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-5, naznačen time, da metabolička bolest je pretilost.
7. Pripravak za uporabu prema patentnom zahtjevu 6, naznačen time, da pretilost je pretilost koja je inducirana prehranom.
8. Pripravak za uporabu prema patentnom zahtjevu 6 ili 7, naznačen time, da pretilost je sarkopenijska pretilost.
9. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-5, naznačen time, da metabolička bolest je dijabetes.
10. Pripravak za uporabu prema patentnom zahtjevu 9, naznačen time, da dijabetes je dijabetes tipa II.
11. Pripravak za uporabu prema patentnom zahtjevu 9, naznačen time, da dijabetes je dijabetes tipa I.
12. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-5, naznačen time, da metabolička bolest je NASH.
13. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-12, naznačen time, da primjena pripravka uzrokuje najmanje jedno od sljedećih:
a) povećanje mase i/ili funkcije mišićnog tkiva kod ljudskog pojedinca;
b) povećanje mase i/ili funkcije mišićnog tkiva brze kontrakcije kod ljudskog pojedinca;
c) povećanje mase i/ili funkcije mišićnog tkiva spore kontrakcije kod ljudskog pojedinca;
d) povećanje brzine metabolizma kod ljudskog pojedinca;
e) povećanje inzulinske osjetljivosti kod ljudskog pojedinca;
f) povećanje razine smeđeg masnog tkiva kod ljudskog pojedinca;
g) povećanje razine bež masnog tkiva kod ljudskog pojedinca;
h) smanjenje razine bijelog masnog tkiva kod ljudskog pojedinca;
i) smanjenje razine visceralnog masnog tkiva kod ljudskog pojedinca;
j) smanjenje omjera masnog tkiva prema mišićnom tkivu kod ljudskog pojedinca;
k) povećanje nakupljanja glukoze putem ciljanog tkiva kod ljudskog pojedinca, pri čemu se ciljano tkivo bira iz skupine koju čine smeđe masno tkivo, bež masno tkivo, i mišićno tkivo;
l) smanjenje nakupljanja glukoze putem ciljanog tkiva kod ljudskog pojedinca, pri čemu se ciljano tkivo bira iz skupine koju čine bijelo masno tkivo, i tkivo jetre;
m) smanjenje mišićnog katabolizma proteina i/ili mišićnog otpuštanja aminokiselina kod ljudskog pojedinca;
n) povećanje glikemijske kontrole ovisne o inzulinu kod ljudskog pojedinca;
o) smanjenje unutarmišićne infiltracije masnoće kod ljudskog pojedinca;
p) poboljšanje standardiziranih testnih rezultata kvalitete života;
q) sprečavanje gubitka mišića ili mišićne atrofije kod ljudskog pojedinca;
r) povećanje gustoće kostiju ili volumen;
s) sprečavanje ili smanjenje gubitka kostiju ili frakture;
t) smanjenje preopterećenja fluidom ili edema koji je povezan s kroničnim srčanim zastojem (CHF); i/ili
u) pospješivanje učinkovite osjetljivosti pojedinca na liječenje.
14. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-13, naznačen time, da se protutijelo, ili njegov fragment koji veže antigen, ne veže na GDF11 ili Aktivin, opcionalno gdje se protutijelo, ili njegov fragment koji veže antigen, ne veže na zreli miostatin, GDF11 ili Aktivin.
15. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-14, naznačen time, da protutijelo, ili njegov fragment koji veže antigen sadrži regiju koja određuje komplementarnost (CDR) H1 kao što je u SEQ ID NO: 1 ili 2, CDR H2 u skladu sa SEQ ID NO: 4 ili 5, CDR H3 u skladu sa SEQ ID NO: 10, CDR L1 u skladu sa SEQ ID NO: 12 ili 13, CDR L2 u skladu sa SEQ ID NO: 18 ili 19, i CDR L3 u skladu sa SEQ ID NO: 22.
16. Pripravak za uporabu prema patentnom zahtjevu 15, naznačen time, da protutijelo, ili njegov fragment koji veže antigen, sadrži:
a) varijabilnu regiju teškog lanca koja ima aminokiselinski slijed SEQ ID NO: 25 i varijabilnu regiju lakog lanca koja ima aminokiselinski slijed SEQ ID NO: 31; ili
b) teški lanac koji sadrži aminokiselinski slijed SEQ ID NO: 50 i laki lanac koji sadrži aminokiselinski slijed SEQ ID NO: 51.
17. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-16, naznačen time, da se protutijelo, ili njegov fragment koji veže antigen, natječe za vezanje na pro/latentni miostatin s protutijelom, ili njegovim fragmentom koji veže antigen iz patentnog zahtjeva 16.
18. Pripravak za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da se afinitet protutijela, ili njegovog fragmenta koji veže antigen za FcRn, povećava kako bi se proširila njegova farmakokinetička svojstva; opcionalno pri čemu se protutijelo, ili njegov fragment koji veže antigen konstruira inženjeringom kako bi vezao FcRn s većim afinitetom uz pH 7,4.
19. Pripravak za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da se pripravak primjenjuje supkutano.
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762443455P | 2017-01-06 | 2017-01-06 | |
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EP18701237.2A EP3565592B1 (en) | 2017-01-06 | 2018-01-05 | Treating metabolic diseases by inhibiting myostatin activation |
PCT/US2018/012686 WO2018129395A1 (en) | 2017-01-06 | 2018-01-05 | Methods for treating metabolic diseases by inhibiting myostatin activation |
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EP3215175A4 (en) | 2014-11-06 | 2018-06-27 | Scholar Rock, Inc. | Anti-pro/latent-myostatin antibodies and uses thereof |
KR20230155021A (ko) | 2015-09-15 | 2023-11-09 | 스칼러 락, 인크. | 항-프로/잠재성-미오스타틴 항체 및 그의 용도 |
AU2017206069A1 (en) | 2016-01-08 | 2018-07-19 | Scholar Rock, Inc. | Anti-pro/latent myostatin antibodies and methods of use thereof |
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EP3565592A1 (en) | 2019-11-13 |
US20190345239A1 (en) | 2019-11-14 |
JP7198757B2 (ja) | 2023-01-04 |
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JP2023012515A (ja) | 2023-01-25 |
US11155611B2 (en) | 2021-10-26 |
US20220106390A1 (en) | 2022-04-07 |
RS64159B1 (sr) | 2023-05-31 |
SI3565592T1 (sl) | 2023-05-31 |
EP3565592B1 (en) | 2023-03-01 |
ES2944357T3 (es) | 2023-06-20 |
CA3088855A1 (en) | 2018-07-12 |
EP4218817A3 (en) | 2023-09-06 |
AU2018205270A1 (en) | 2019-08-22 |
PL3565592T3 (pl) | 2023-08-21 |
JP2020514295A (ja) | 2020-05-21 |
AU2022268305A1 (en) | 2022-12-15 |
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