HRP20220999T1 - Terapija za ulcerozni kolitis zasnovana na oligonukleotidu - Google Patents

Terapija za ulcerozni kolitis zasnovana na oligonukleotidu Download PDF

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HRP20220999T1
HRP20220999T1 HRP20220999TT HRP20220999T HRP20220999T1 HR P20220999 T1 HRP20220999 T1 HR P20220999T1 HR P20220999T T HRP20220999T T HR P20220999TT HR P20220999 T HRP20220999 T HR P20220999T HR P20220999 T1 HRP20220999 T1 HR P20220999T1
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oligonucleotide
subject
use according
single doses
administered
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HRP20220999TT
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Peter ZERHOUNI
Pernilla SANDWALL
Thomas Knittel
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Index Pharmaceuticals Ab
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    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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Claims (15)

1. Oligonukleotid koji se sastoji iz sekvence 5’-GGAACAGTTCGTCCATGGC-3’ (SEQ ID NO:2) za upotrebu u liječenju upalne bolesti crijeva u humanom subjektu preko lokalne primjene u debelom crijevu, pri čemu subjekt nije bio izložen čišćenju debelog crijeva prije spomenute primjene.
2. Oligonukleotid za upotrebu prema zahtjevu 1, pri čemu se spomenuta lokalna primjena vrši preko klizme koja je pogodna za samostalnu primjenu od strane pacijenta, poželjno gdje spomenuta klizma ima izduženi vrh oblikovan tako da omogući umetanje u rektum, poželjnije gdje spomenuti izduženi vrh ima dužinu od 4 do 10 cm.
3. Oligonukleotid za upotrebu prema zahtjevu 1 ili zahtjevu 2, pri čemu subjekt nije bio izložen čišćenju debelog crijeva tokom 24 h prije tretmana s oligonukleotidom, poželjno tokom 48 h prije tretmana s oligonukleotidom.
4. Oligonukleotid za upotrebu prema bilo kojem prethodnom zahtjevu, pri čemu spomenuta upalna bolest crijeva je ulcerozni kolitis, poželjno gdje je subjektu dijagnosticiran ulcerozni kolitis lijeve strane.
5. Oligonukleotid za upotrebu prema bilo kojem prethodnom zahtjevu, pri čemu su pojedinačne doze od 150mg do 350mg spomenutog oligonukleotida primijenjene na subjektu u bar dva odvojena slučaja, pri čemu su spomenuti slučajevi u razmaku od 3 tjedna.
6. Oligonukleotid za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu je subjekt otporan ili nedovoljno reagira ili je intolerantan na terapiju protiv upale.
7. Oligonukleotid za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu je spomenuti subjekt odabran za kolektomiju.
8. Oligonukleotid za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu spomenuti oligonukleotid ima sekvencu 5’-GGAACAGTTCGTCCATGGC-3’ (SEQ ID NO:2), u kojoj je CG dinukleotid nemetiliran.
9. Oligonukleotid za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu spomenuti oligonukleotid ima sekvencu 5’- G∗G∗A∗ACAGTTCGTCCAT∗G∗G∗C-3’ (SEQ ID NO:1), u kojoj je CG dinukleotid nemetiliran, i ∗ označava fosforotioatnu internukleozidnu vezu, poželjno pri čemu je oligonukleotid kobitolimod.
10. Oligonukleotid za upotrebu prema bilo kojem od zahtjeva 5 do 9, gdje su primijenjene pojedinačne doze od 240mg do 260mg spomenutog oligonukleotida.
11. Oligonukleotid za upotrebu prema bilo kojem od prethodnih zahtjeva, gdje su primijenjene pojedinačne doze od oko 250mg spomenutog oligonukleotida.
12. Oligonukleotid za upotrebu prema bilo kojem od prethodnih zahtjeva, gdje (a) pojedinačne doze spomenutog oligonukleotida su primijenjene na subjektu u samo dva odvojena slučaja u razmaku od 3 tjedna; ili (b) pojedinačne doze spomenutog oligonukleotida su primijenjene na subjektu u dva ili više odvojenih slučajeva u razmaku od 3 tjedna do postizanja remisije kod subjekta.
13. Oligonukleotid za upotrebu prema bilo kojem od prethodnih zahtjeva, gdje subjekt dobiva jedan ili više dodatnih terapeutskih sredstava za liječenje upalne bolesti crijeva, obično ulceroznog kolitisa.
14. Oligonukleotid za upotrebu prema bilo kojem od prethodnih zahtjeva, gdje je oligonukleotid kobitolimod, i pojedinačne doze od oko 250mg kobitolimoda su primijenjene na subjektu u samo dva odvojena slučaja u razmaku od 3 tjedna.
15. Farmaceutski sastav koji sadrži oligonukleotid kao što je definirano u bilo kojem od zahtjeva 1, 8 i 9, zajedno s jednim ili više farmaceutski prihvatljivih nosača, za upotrebu u liječenju upalne bolesti crijeva kao što je definirano u bilo kojem od zahtjeva 1 i 4 u humanom subjektu kao što je definirano u bilo kojem od zahtjeva 1, 3, 6, 7 i 13, poželjno gdje su pojedinačne primjene spomenutog sastava primijenjene na subjektu u bar dva odvojena slučaja, pri čemu su spomenuti odvojeni slučajevi u razmaku od 3 tjedna, i poželjno gdje svaka primjena sastava isporučuje količinu oligonukleotida kao što je definirano u bilo kojem od zahtjeva 5, 10, 11 i 14.
HRP20220999TT 2019-08-24 2020-08-21 Terapija za ulcerozni kolitis zasnovana na oligonukleotidu HRP20220999T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB1912191.2A GB201912191D0 (en) 2019-08-24 2019-08-24 New therapy
EP20760858.9A EP3947685B1 (en) 2019-08-24 2020-08-21 Oligonucleotide-based therapy for ulcerative colitis
PCT/EP2020/073566 WO2021037764A1 (en) 2019-08-24 2020-08-21 Oligonucleotide-based therapy for ulcerative colitis

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EP (1) EP3947685B1 (hr)
JP (1) JP2022545692A (hr)
KR (2) KR102592716B1 (hr)
CN (1) CN114599376A (hr)
AU (1) AU2020335171A1 (hr)
BR (1) BR112022002612A2 (hr)
CA (1) CA3151203A1 (hr)
DK (1) DK3947685T3 (hr)
ES (1) ES2925460T3 (hr)
GB (1) GB201912191D0 (hr)
HR (1) HRP20220999T1 (hr)
HU (1) HUE059642T2 (hr)
LT (1) LT3947685T (hr)
PL (1) PL3947685T3 (hr)
PT (1) PT3947685T (hr)
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GB202018468D0 (en) * 2020-11-24 2021-01-06 Index Pharmaceuticals Ab New therapy
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ES2925460T3 (es) 2022-10-18
KR20230148402A (ko) 2023-10-24
CA3151203A1 (en) 2021-03-04
SI3947685T1 (sl) 2022-09-30
PL3947685T3 (pl) 2022-11-21
EP3947685A1 (en) 2022-02-09
EP3947685B1 (en) 2022-07-13
HUE059642T2 (hu) 2022-12-28
KR20220050927A (ko) 2022-04-25
AU2020335171A1 (en) 2022-02-24
US20220378818A1 (en) 2022-12-01
BR112022002612A2 (pt) 2022-05-03
DK3947685T3 (da) 2022-08-08
GB201912191D0 (en) 2019-10-09
CN114599376A (zh) 2022-06-07
KR102592716B1 (ko) 2023-10-20
RS63640B1 (sr) 2022-10-31
PT3947685T (pt) 2022-08-18
JP2022545692A (ja) 2022-10-28
LT3947685T (lt) 2022-08-25

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