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Galapagos december 2020

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Missolapola
4
quote:

Egomarinus schreef op 1 december 2020 08:40:


@Kelewan: Waar is het officiële december draadje aub?

Volgens mij is het draadje met de meest logische titel, het officiële december draadje
NewKidInTown
0
"Galapagos : reports positive topline results with GLPG1205 in IPF patients in PINTA Proof-of-Concept trial
11/30/2020 | 04:01pm EST

Placebo-adjusted improvement in forced vital capacity (FVC) decline of 42mL across treatment groups at 26 weeks
Correlation between FVC decline and pulmonary lobar volume change observed, as measured by functional respiratory imaging (FRI)
GLPG1205 planned to progress to dose finding Phase 2b study

Mechelen, Belgium; 30 November 2020, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) announces positive topline results with its investigational GPR84 antagonist GLPG1205 in Proof-of-Concept Phase 2 trial in idiopathic pulmonary fibrosis (IPF) patients.

The PINTA trial was a randomized, double-blind, placebo-controlled trial investigating a 100mg once-daily oral dose of GLPG1205. The study recruited and included a total of 68 IPF patients. Participants were administered drug candidate or placebo (2:1 randomization) for 26 weeks and could remain on their standard of care as background therapy, i.e. nintedanib, pirfenidone or neither. The primary objective of the trial was to assess the change from baseline in FVC (in mL) over 26 weeks compared to placebo. Other measures included safety, tolerability, time to major events, changes in functional exercise capacity, quality of life, pharmacokinetics, pharmacodynamics and FRI.

At week 26, patients receiving GLPG1205 on top of standard of care showed a smaller FVC decline, with a difference of 42mL versus placebo on top of standard of care (-76mL on placebo; -34mL on treatment). The study was not powered to show statistical significance. The FVC trend was consistent across the three treatment strata. In addition, the change in pulmonary lobar volume, as measured by FRI, correlates with the FVC decline observed.

No relevant safety signals were observed for GLPG1205 alone and on top of pirfenidone. The most frequently reported adverse events on GLPG1205 alone were gastrointestinal disorders, especially nausea. In the treatment arm of GLPG1205 on top of nintedanib, a higher rate of early discontinuations and high grade TEAEs were observed. In the arm of the study with GPLG1205 on top of nintedanib, there was one death due to an exacerbation of IPF, which was determined to be unrelated to study treatment.

Based on the results of this trial, Galapagos plans to progress GLPG1205 in a dose finding Phase 2b trial.

The full results of the PINTA trial will be submitted to a future medical conference and peer-reviewed medical journals.

“Keeping in mind the limitations of this early clinical study, the PINTA study with GLPG1205 is a positive trial. The consistent changes observed across treatment strata, using different analytical methods, including FRI, are very encouraging. While we need to understand more about long-term tolerability of the drug, the PINTA results warrant further investigation,” said Prof. Dr. Toby Maher, Professor of Medicine at Keck School of Medicine, University of Southern California.

“We wish to thank participating patients and physicians in the PINTA trial. We are pleased to see a second novel mechanism of action from our innovative platform show early signs of activity in IPF, a highly fatal disease for which improved therapies are desperately needed. This additional novel mode of action may complement the anti-fibrotic approaches within our expanding IPF portfolio,” said Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos.

About GLPG1205 and the fibrosis portfolio
GLPG1205 is a small molecule selectively functionally antagonizing GPR84. Galapagos identified the GPR84 target using its proprietary target discovery platform. GLPG1205 showed promising results in relevant pre-clinical models for IPF. Galapagos currently has several drug candidates with distinct mechanisms of action in its portfolio aimed at building a fibrosis franchise, including ziritaxestat (GLPG1690, autotaxin inhibitor) in the ISABELA Phase 3 program in IPF, ziritaxestat in the NOVESA Phase 2 trial in systemic sclerosis, GLPG1205, GLPG4716 (chitinase receptor inhibitor) preparing for Phase 2 in IPF, and GLPG4124 and GLPG4586, currently in pre-clinical development.

GLPG1205 is investigational; its efficacy and safety have not been evaluated by any regulatory authority.
Information about studies with GLPG1205: www.clinicaltrials.gov
For more information about GLPG1205: www.glpg.com/ipf"

www.marketscreener.com/quote/stock/GA...
poicephalus
3
quote:

Missolapola schreef op 1 december 2020 08:48:


[...]
Volgens mij is het draadje met de meest logische titel, het officiële december draadje

Lijkt me het meest logische. Helaas is de traditie gekaapt door een schreeuwlelijk.
poicephalus
1
quote:

NewKidInTown schreef op 1 december 2020 08:52:


"Galapagos : reports positive topline results with GLPG1205 in IPF patients in PINTA Proof-of-Concept trial
11/30/2020 | 04:01pm EST

Placebo-adjusted improvement in forced vital capacity (FVC) decline of 42mL across treatment groups at 26 weeks
Correlation between FVC decline and pulmonary lobar volume change observed, as measured by functional respiratory imaging (FRI)
GLPG1205 planned to progress to dose finding Phase 2b study

Mechelen, Belgium; 30 November 2020, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) announces positive topline results with its investigational GPR84 antagonist GLPG1205 in Proof-of-Concept Phase 2 trial in idiopathic pulmonary fibrosis (IPF) patients.

The PINTA trial was a randomized, double-blind, placebo-controlled trial investigating a 100mg once-daily oral dose of GLPG1205. The study recruited and included a total of 68 IPF patients. Participants were administered drug candidate or placebo (2:1 randomization) for 26 weeks and could remain on their standard of care as background therapy, i.e. nintedanib, pirfenidone or neither. The primary objective of the trial was to assess the change from baseline in FVC (in mL) over 26 weeks compared to placebo. Other measures included safety, tolerability, time to major events, changes in functional exercise capacity, quality of life, pharmacokinetics, pharmacodynamics and FRI.

At week 26, patients receiving GLPG1205 on top of standard of care showed a smaller FVC decline, with a difference of 42mL versus placebo on top of standard of care (-76mL on placebo; -34mL on treatment). The study was not powered to show statistical significance. The FVC trend was consistent across the three treatment strata. In addition, the change in pulmonary lobar volume, as measured by FRI, correlates with the FVC decline observed.

No relevant safety signals were observed for GLPG1205 alone and on top of pirfenidone. The most frequently reported adverse events on GLPG1205 alone were gastrointestinal disorders, especially nausea. In the treatment arm of GLPG1205 on top of nintedanib, a higher rate of early discontinuations and high grade TEAEs were observed. In the arm of the study with GPLG1205 on top of nintedanib, there was one death due to an exacerbation of IPF, which was determined to be unrelated to study treatment.

Based on the results of this trial, Galapagos plans to progress GLPG1205 in a dose finding Phase 2b trial.

The full results of the PINTA trial will be submitted to a future medical conference and peer-reviewed medical journals.

“Keeping in mind the limitations of this early clinical study, the PINTA study with GLPG1205 is a positive trial. The consistent changes observed across treatment strata, using different analytical methods, including FRI, are very encouraging. While we need to understand more about long-term tolerability of the drug, the PINTA results warrant further investigation,” said Prof. Dr. Toby Maher, Professor of Medicine at Keck School of Medicine, University of Southern California.

“We wish to thank participating patients and physicians in the PINTA trial. We are pleased to see a second novel mechanism of action from our innovative platform show early signs of activity in IPF, a highly fatal disease for which improved therapies are desperately needed. This additional novel mode of action may complement the anti-fibrotic approaches within our expanding IPF portfolio,” said Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos.

About GLPG1205 and the fibrosis portfolio
GLPG1205 is a small molecule selectively functionally antagonizing GPR84. Galapagos identified the GPR84 target using its proprietary target discovery platform. GLPG1205 showed promising results in relevant pre-clinical models for IPF. Galapagos currently has several drug candidates with distinct mechanisms of action in its portfolio aimed at building a fibrosis franchise, including ziritaxestat (GLPG1690, autotaxin inhibitor) in the ISABELA Phase 3 program in IPF, ziritaxestat in the NOVESA Phase 2 trial in systemic sclerosis, GLPG1205, GLPG4716 (chitinase receptor inhibitor) preparing for Phase 2 in IPF, and GLPG4124 and GLPG4586, currently in pre-clinical development.

GLPG1205 is investigational; its efficacy and safety have not been evaluated by any regulatory authority.
Information about studies with GLPG1205: www.clinicaltrials.gov
For more information about GLPG1205: www.glpg.com/ipf"

www.marketscreener.com/quote/stock/GA...

Dit bericht kan wel eens de start zijn van het terugkerend vertrouwen in Galapagos
Macron
0
quote:

moneymaker_BX schreef op 1 december 2020 08:30:


Deze draad sluiten SVP
Draad Moneymaker is Decemberdraad


Voor alle duidelijkheid: Ik vind het ook jammer en een beetje respectloos om plots een nieuwe draad te openen die anders steeds door dezelfde persoon geopend werd. Om hier nu te gaan bepalen welke draad nu de echte is en welke moet sluiten is echter van hetzelfde bedenkelijk niveau.
De lezers zullen zelf wel bepalen waar ze hun ding kwijt willen.
Wilbar
1
quote:

moneymaker_BX schreef op 1 december 2020 08:30:


Deze draad sluiten SVP
Draad Moneymaker is Decemberdraad
Wij wachten tot u zichzelf sluit.
Mippert
0
Goedemorgen. Is dit de officiële draad?

Open op 105,95 en nu al door de 106,50

Natuurlijk lijstaanvoerder AEX!

Mijn dag kan niet meer stuk (behalve als ie weer in kakt).
poicephalus
0
quote:

Ceteris Paribus schreef op 1 december 2020 09:00:


Laten we het hopen.

De start is wel heel voorzichtig met 2,5% stijging
mercurius-adept
3
quote:

zakgeld schreef op 30 november 2020 18:55:


Als (bijna) alleen lezer graag wat meer respect voor elkaar. Gezien de vele reacties op MM kan wellicht dit draadje dienen om meer inhoudelijk met elkaar te communiceren. Het draadje van MM kan dan voor de trollen. Waarschijnlijk, maar hopelijk niet, is dit een illusie. Veel succes en geluk allen.


wat een sneue actie dit, gun die gozert zijn draadje...kan het jou wat wie hem opent....?


(maakt mij geen snars uit wie wat opent...vind je actie best kinderachtig op een forum voor volwassenen..hmmm )
abelheira
0
quote:

poicephalus schreef op 1 december 2020 09:03:


[...]
De start is wel heel voorzichtig met 2,5% stijging

Koffiedik kijken of dit nieuws wel belangrijk genoeg is om de koers gevoelig te doen stijgen.
ben alleszins blij dat het niet negatief is.
Raasgier
5
quote:

mercurius-adept schreef op 1 december 2020 09:03:


[...]

wat een sneue actie dit, gun die gozert zijn draadje...?
kan het jou wat wie hem opent....


(maakt mij geen snars uit wie wat opent...vind je actie best kinderachtig op een forum voor volwassenen)


Ik moet zeggen dat ik de actie van Zakgeld eigenlijk vrij volwassen vond op een forum dat zich laat terroriseren door kinderachtig gedoe. Het betreffende andere figuur meent draadjes te mogen sluiten. Dat is pas echt beneden de maat. Ik beoogde gisteravond dat laatste flink te counteren door hier even een liedje te zingen. Ik realiseer me nu dat dat door de hoofdletters mogelijk wat schreeuwerig overkwam. Excuses dus voor de hoofdletters, verder sta ik volledig achter de inhoud. Verder lijkt het mij prima als Mippert dit draadje wat meer spin geeft, zodat duidelijk mag zijn dat niets zich hier laat sluiten.
Mippert
1
Nu zou ik toch graag willen weten wat er gisteren aan de hand was:

1. VK van komst van PB, inhoud onbekend en voorsorteren op matig nieuws;
2. VK van komst PB, inhoud bekend en alvast drukken om de koers niet te hard op te laten lopen
3. anders, te weten ..........
zonsverduistering
3
Mippert
0
poicephalus
0
quote:

abelheira schreef op 1 december 2020 09:05:


[...]
Koffiedik kijken of dit nieuws wel belangrijk genoeg is om de koers gevoelig te doen stijgen.

Voor de koers doet het inderdaad niet veel met 4% nu, maar het vertrouwen komt terug en de koers volgt vanzelf
Macron
0
Grafisch (technisch) komt dit nieuws als geroepen. Lijkt erop dat ze door de negatieve spiraal breken. Dan ligt de weg naar 130+ zo open.
mercurius-adept
1
quote:

zonsverduistering schreef op 1 december 2020 09:08:


En...zijn jullie er al uit wie het schepje mag vasthouden in de zandbak....


ikke...neee ikke....nee ikke...juf hij doet verveeeelllleeeendddd :)))
Fermín Romero de Torres
0
Het blijft wachten op de resultaten uit de FDA-meeting voordat er iets substantieels met de koers gebeurt. De stijging nu is peanuts.
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Vertraagd 29 nov 2021 17:35
Koers 43,000
Verschil +0,405 (+0,95%)
Hoog 43,315
Laag 42,505
Volume 191.329
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Volume gisteren 282.874