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Galapagos 2018. De inhoudelijke discussie.

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Opop
2
doc-0c-a0-docs.googleusercontent.com/...

Conclusion:
'If one JAK inhibitor increases thromboembolic risks, it is likely that others may too – Clinicians prescribing JAK inhibitors for RA should use them cautiously in patients with pre-existing potential thromboembolic risks'

Filgotinib gaat dus waarschijnlijk het tegendeel bewijzen en zich onderscheiden.
aston.martin
0
quote:

NielsjeB schreef op 24 aug 2018 om 07:50:


Nice Beurskingpin.

Zuiderbuur heeft in 2017 dat IRAK-inhibitor patent al eens geplaatst [1], maar de PDF daarvan kan ik niet meer openen.

[1] www.iex.nl/Forum/Post/10012641.aspx



worldwide.espacenet.com/publicationDe...

Opop
3
quote:

Opop schreef op 25 aug 2018 om 22:29:


doc-0c-a0-docs.googleusercontent.com/...

Conclusion:
'If one JAK inhibitor increases thromboembolic risks, it is likely that others may too – Clinicians prescribing JAK inhibitors for RA should use them cautiously in patients with pre-existing potential thromboembolic risks'

Filgotinib gaat dus waarschijnlijk het tegendeel bewijzen en zich onderscheiden.

Link werkt niet meer, vreemd. Artikel in bijlage.
Bijlage:
NielsjeB
4
Bridge Biotherapeutics Presented Preclinical Study Results on BBT-877, an Autotaxin inhibitor at the IPF Summit 2018

www.prnewswire.com/news-releases/brid...

Ik heb bij Bridge Biotherapeutics de bijbehorende poster opgevraagd, zie bijlage. Ze verwezen me naar een artikel in het Koreaans. Zie de Google Translate vertaling [1].

Het gaat dus om een molecuul dat preklinisch is getest en vergeleken met o.a. GLPG1690.

[1] translate.google.com/translate?hl=en&...
Bijlage:
NielsjeB
8
Volume 53, Issue S2
The 32nd Annual North American Cystic Fibrosis Conference, Colorado Convention Center, Denver, Colorado, October 18–20, 2018


onlinelibrary.wiley.com/toc/10990496/...
NielsjeB
2
NielsjeB
2
42
THE NEXT GENERATION GALAPAGOS CORRECTOR
C2A RESCUES DOMAIN ASSEMBLY OF MUTANT CFTR
Bijlage:
NielsjeB
3
186
THE EFFECT OF GALAPAGOS AND ABBVIE TRIPLE
CFTR MODULATOR THERAPY ON FORSKOLININDUCED
SWELLING OF NASAL AND BRONCHIAL
ORGANOIDS FROM CYSTIC FIBROSIS PATIENTS
Bijlage:
NielsjeB
3
269
RESULTS FROM A PHASE II STUDY - ALBATROSS -
EVALUATION OF GLPG2222 IN SUBJECTS WITH CF
AND THE F508DEL/CLASSIII MUTATION ON STABLE
TREATMENT WITH IVACAFTOR
Bijlage:
NielsjeB
3
271
GLPG2222 IN CF SUBJECTS HOMOZYGOUS FOR
F508DEL: RESULTS FROM A PHASE II STUDY
(FLAMINGO)
Bijlage:
NielsjeB
2
286
DECIPHERING POSSIBLE MECHANISMS OF
ACTION OF CFTR CORRECTORS - “AN ABBVIE AND
GALAPAGOS EXPERIENCE”
Bijlage:
NielsjeB
2
289
EVALUATION OF GALAPAGOS-ABBVIE CFTRMODULATORS
USING INTESTINAL ORGANOID ASSAYS
Bijlage:
avantiavanti
16
Hele interessante data van BrystelMyerSquib gisteren, zie hieronder analyse van Kempen.

BMS LPA1 antagonist gives credence to GLPG1690 target and data GLPG NA

11 September 2018, 08:46

BMS published the results for its terminated phase II trials with LPA1 receptor antagonist (Palmer, 2018), demonstrating a stat sig slowdown in FVC decline in IPF patients, supported by the numerically higher proportion of patients with no decline in FVC. In our view, the results not only provide validation of targeting the ATX-LPA pathway in fibrosis, but also give credence to the observed stabilization of FVC in the phase II FLORA trial with Galapagos' GLPG1690. Meanwhile, the observed safety issues with LPA1 receptor antagonist that led to the termination of the program, were identified as off-target toxicities related to the specific drug profile with no read-through to GLPG1690. We believe if GLPG1690 maintains the magnitude of disease stabilization shown in the FLORA trial, it would be positioned to take the leading market share among second-generation therapies.

Efficacy validates LPA as a target in IPF. The phase II study with BMS' LPA1 receptor antagonist BMS-986020 in IPF demonstrated significantly slower rates of FVC decline at 600mg BID dose -42ml vs. -134ml placebo after 26 weeks. The finding was further supported by a numerically higher percentage of patients not experiencing a decline in FVC: 38% vs. 18% The authors concluded that demonstrated results are suggestive of a clinical benefit with LPA1 inhibition in IPF. In our view, the results also provide validation for Galapagos' GLPG1690, an inhibitor of autotaxin - a key enzyme in the production of LPA, and observed stabilization of FVC (+8ml vs. -87ml at w12) in its phase IIa FLORA study, suggesting a biological drug effect rather than random fluctuations of spirometry results.

Safety issues are off target, drug-specific. Although the treatment was well tolerated in most patients, the study was terminated prematurely on the evidence of hepatobiliary toxicity as manifested by dose-related elevations in hepatic transaminases and ALP and 3 cases treatment-related cholecystitis. Based on preclinical research, the authors concluded that the liver toxicity was off-target, drug-specific effects related to inhibition of hepatobiliary transporters and bile composition and not related to LPA1 antagonism (Rosen, 2017). The phase II FLORA trial with GLPG1690 and the phase I trial in healthy volunteers did not identify any significant safety and tolerability issues in 17 IPF patients treated with GLPG1690 for 12 weeks: mainly headaches and no signs of hepatotoxicity
holenbeer
1
Heel goed nieuws, AvantiAvanti, dank! Wanneer worden resultaten FLORA ook weer verwacht, dit jaar nog? Er loopt zoveel, niet bij te houden.
Beurskingpin
0
quote:

holenbeer schreef op 11 sep 2018 om 11:36:


Heel goed nieuws, AvantiAvanti, dank! Wanneer worden resultaten FLORA ook weer verwacht, dit jaar nog? Er loopt zoveel, niet bij te houden.


Binnen 2.5 jaar ongeveer, met wat geluk lol..
maxen
1
quote:

holenbeer schreef op 11 sep 2018 om 11:36:


Heel goed nieuws, AvantiAvanti, dank! Wanneer worden resultaten FLORA ook weer verwacht, dit jaar nog? Er loopt zoveel, niet bij te houden.

Publicatie results FLORA phase 2: 9 augustus 2017:
www.glpg.com/docs/view/598b6182b414d-en

De grote IPF trials met 1500 deelnemers heten Isabella 1 & 2, starten nog dit jaar. Duurt dan nog jaren voordat er resultaten zijn.

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