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Inhoudelijk Toledo Draadje

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Wall Street Trader 2 april 2021 19:02

A Study to Evaluate How Well Single and Multiple Doses of GLPG4399 Are Tolerated in Healthy, Adult Subjects.

clinicaltrials.gov/ct2/history/NCT046...

Loureiro 12 april 2021 11:44

quote:
Lama Daila schreef op 13 februari 2021 10:31:
clinicaltrials.gov/ct2/history/NCT045...

LADYBUG (GLPG3970 in RA) is al volledig gerecruteerd.
Study completion is met een maand vervroegd: van mei naar april

28 patiënten ipv 25

Deze studie zou toch al "completed" moeten zijn?

[verwijderd] 15 april 2021 14:54

www.clinicaltrials.gov/ct2/show/NCT04...

Studie met 3970 in UC is nu ook lopende. Active!

Lama Daila 19 april 2021 13:05

clinicaltrials.gov/ct2/history/NCT047...

TAPINOMA studie (GLPG3970 in SLE): 3 nieuwe locaties in Polen.

Lama Daila 19 april 2021 13:09

Tijd voor wat educatie :)

TAPINOMA wordt ook wel “draaigatje” genoemd

nl.wikipedia.org/wiki/Mediterraan_dra...

De benaming draaigatje komt van de door de mier toegepaste manier van verdedigen: eerst bijten en dan het achterlijf naar de wond draaien en er een irriterende stof in spuiten.

avantiavanti 19 april 2021 21:02

Rigorous new review of SIKs biology and therapeutic potential for diseaseses.

Nuts and bolts of the salt-inducible kinases (SIKs)

Bijlage:

Lama Daila 27 april 2021 21:53

Het patent voor GLPG3970 (2e Toledo patent) is op 21/04 gepubliceerd.

patentscope.wipo.int/search/en/detail...

patentscope.wipo.int/search/docs2/wip...

Provisional protection under Article 67:
www.epo.org/law-practice/legal-texts/...

Protectie tot 2019 + 20 = 2039

Wall Street Trader 30 april 2021 10:44

Gilead Sciences (GILD) Q1 2021 Earnings Call Transcript

GILD earnings call for the period ending March 31, 2021.

Galapagos SIK2/3 Toledo proof-of-concept trials across psoriasis, ulcerative colitis, and RA are expected to have readouts later this year.

Our next question comes from Matthew Harrison with Morgan Stanley.

Matthew Harrison -- Morgan Stanley -- Analyst

Great. Good afternoon. Thanks for taking the question. A question on Galapagos, and I guess there are two parts here.

First part is, you know, you've got these upcoming Toledo readouts. Merdad, maybe you could just comment on what you're potentially looking to see from those readouts, given that the duration of those trials is fairly short. So maybe what you would view as sort of a positive outcome. And then I guess second question is a more sort of broader strategic question here.

But if you don't see something that's positive out of those, you know, how do you think about the longer-term relationship there? And given that you're the largest shareholder, you know, what might you consider in terms of that relationship?

Merdad Parsey -- Chief Medical Officer

Yes, sure. It's a great question. And I think you -- Matthew, you mentioned, I think, look, where we are now with the Toledo programs is looking for evidence of tolerability and proof-of-concept, proof of principle for that pathway in multiple indications. And I would describe these early small studies as a place to demonstrate that and look to see where the biggest impact could be.

I think it's an early part of the longer journey, ranging from -- you know, is there a particular indication that we want to pursue further to confirm and expand on the signal to -- you know, do we have the right molecule for that. So I think we view these, together with Galapagos, I believe, we view these as sort of very early in the story of the Toledo program. So we'll be looking to see what those data look like in the near term. Dan, do you want add?

Daniel O'Day -- Chairman and Chief Executive Officer

Sure. So maybe just to you, Matthew, to just give a little bit of context of people that may not be completely familiar with our relationship with Galapagos. So of course, there was the filgotinib relationship, but then there was a separate relationship that we went into. As you know, a couple of years ago now.

And that was really based on the research platform. And I would say that nothing has really changed in relation to that. I mean one of the reasons to do that was to diversify our approaches from a discovery research perspective across, if you like, the Gilead Group. I listened hard to the scientists at that time.

I continue to listen hard to the scientists today. They think they have a very discriminated platform for screening compounds for first-in-class. And I'll remind you, that's really the approach first-in-class, which, of course, comes with some risks, some of which we've seen in the later-stage programs. And of course, Toledo is the most advanced now of those programs.

But having said that, there are many others within their discovery platform that we continue to be intrigued about. I think it's an important part of our overall inflammation strategy, albeit at an earlier stage for Gilead. But when we think about our strategic approach that really focuses on immunology and virology as our core scientific skills, we have now obviously leaders in virology built up a really significant presence in oncology with inflammatory disorders, really kind of the next step and the next stage of our platform where Galapagos presents, I think one aspect of that, but a very important aspect in terms of first-in-class approach. So we continue to be working very closely with our partners at Galapagos to determine what the next screens are and what the next targets are in the concept of our -- the entirety of our inflammation strategy.

So thanks, Matt.

Inflammatory Diseases Pipeline (Pipeline shown below as of end of Q121)

Bijlage:

Lama Daila 6 mei 2021 21:29

quote:
Wall Street Trader schreef op 20 februari 2021 17:41:
Thanks to pate

Salt-inducible kinases are required for the IL-33-dependent secretion of cytokines and chemokines in mast cells

16 February 2021

Interestingly, the biotechnology company Galapagos disclosed on October 27th 2020 that compounds from their “Toledo” programme, target the SIK family of protein kinases and that a dual SIK2/SIK3 inhibitor GLPG3970 had passed Phase I trials and would soon be entering advanced clinical trials for Psoriasis, Rheumatoid Arthritis and Ulcerative Colitis. The present study, which shows that the combined inhibition of SIK2/3 suppresses the production of a number of cytokines and chemokines that contribute to the pathogenesis of asthma now suggests that GLPG3970 and/or related compounds may be worth exploring as potential treatments for asthma patients who are refractory to the corticosteroid therapies that are in widespread use.

www.sciencedirect.com/science/article...

Zelfde artikel (in meer leesbare layout) van University of Dundee:
discovery.dundee.ac.uk/ws/portalfiles...

“Our results suggest that dual inhibitors of SIK2 and SIK3 may have therapeutic potential for the treatment of mast cell–driven diseases.”

GLPG3970 zou dus mogelijk ook wel eens kunnen werken tegen asthma, of andere mast cell-driven diseases.

Lama Daila 6 mei 2021 22:18

quote:
Lama Daila schreef op 26 maart 2021 07:36:
[...]

In de webcast van Piet met Morgan Stanley verduidelijkt Pïet dat GLPG4876 een backup is voor GLPG3970 en dat er momenteel weinig of geen plannen zijn met GLPG4876

morganstanley.webcasts.com/viewer/eve...

Q1 2021: We selected an additional molecule from our Toledo program, SIK2/3 inhibitor ‘4876, as a candidate to accelerate from preclinical phase into clinical development;

Backup voor GLPG3970 die uit de schuif gehaald wordt??

Lama Daila 6 mei 2021 22:26

Q1 2021: We completed enrollment of the SEA TURTLE Phase 2 study with ‘3970 in UC

Wall Street Trader 10 mei 2021 21:27

A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate (LADYBUG)

Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : May 10, 2021

clinicaltrials.gov/ct2/show/NCT04577781

Endless 11 mei 2021 08:38

quote:
Wall Street Trader schreef op 10 mei 2021 21:27:
A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate (LADYBUG)

Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : May 10, 2021

clinicaltrials.gov/ct2/show/NCT04577781

De data zijn dus bekend hopelijk snel geëvalueerd gezien de kleine aantal deelnemers.

Lama Daila 28 mei 2021 20:22

Kleine nieuwe Toledo study met GLPG3970:
clinicaltrials.gov/ct2/show/NCT04907149

Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970

6 personen, Completion date Juni 21

A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG3970 in Healthy Male Subjects Following a Single Oral Dose of GLPG3970 Relative to an Intravenous [14C]GLPG3970 Microtracer and Single Oral [14C]GLPG3970 Administration

Drug: GLPG3970 film-coated tablet
Participants will receive a single oral dose of GLPG3970.

Drug: [14C]GLPG3970 solution for infusion
Participants will receive an i.v. microtracer microdose.

Loureiro 20 juni 2021 21:12

quote:
Wall Street Trader schreef op 10 mei 2021 21:27:
A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate (LADYBUG)

Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : May 10, 2021

clinicaltrials.gov/ct2/show/NCT04577781

Hoe zit het eigenlijk met het onderzoek in UC : had toch ook al completed moeten zijn?????

MtBaker 21 juni 2021 08:44

quote:
abelheira schreef op 20 juni 2021 21:12:
[...]
Hoe zit het eigenlijk met het onderzoek in UC : had toch ook al completed moeten zijn?????

zie iets hoger 6 mei dus

Loureiro 21 juni 2021 09:59

quote:
MtBaker schreef op 21 juni 2021 08:44:
[...]zie iets hoger 6 mei dus

Enrollment is completed maar onderzoek zou ook al completed moeten zijn.

Down the drain 2 21 juni 2021 10:05

quote:
abelheira schreef op 21 juni 2021 09:59:
[...]
Enrollment is completed maar onderzoek zou ook al completed moeten zijn.

Op 4 mei al een publicatie over fase 3 in The Lancet verschenen.

[verwijderd] 21 juni 2021 10:12

quote:
Down the drain 2 schreef op 21 juni 2021 10:05:
[...]

Op 4 mei al een publicatie over fase 3 in The Lancet verschenen.

Het gaat over Toledo, niet over de Ph 3 studie met Filgotinib in UC.
Die is in The Lancet verschenen laatst.

De 3970 studie in UC was mid april 'completed enrollment' --> Active, not recruiting dus.
Wil zeggen 6 weken extra + 2 weken follow up --> mid juni completed studie.
Tenminste indien de timings op clinical trials kloppen wat niet altijd het geval is.

Vaak worden die ook pas een maand later bijgewerkt (zie eerdere studies met 3970, 3667 en Filgotinib). Studie is dus completed nu, maar moet nog aangepast worden op clinical trials, in juli zouden de eerste drie POC's hiervan uitlezen.

de tuinman 21 juni 2021 14:54

quote:
Down the drain 2 schreef op 21 juni 2021 10:05:
[...]

Op 4 mei al een publicatie over fase 3 in The Lancet verschenen.

Je weet ook echt niet waar het over gaat, of wel?

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