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Galapagos 2018. De inhoudelijke discussie.

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k61
0
quote:

RW1963 schreef op 19 maart 2018 20:41:

Wie weet toch waar pe26 is gebleven? Al heel lang radiostilte.
Mogelijk een spreekverbod van Galapagos???
Gala-diner
0
quote:

k61 schreef op 19 maart 2018 19:07:

Beyond Kite, many other takeover targets exist. It could buyout the rest of Galapagos (GLPG) for the rights to Rheumatoid Arthritis and Crohn's Disease drug filgotinib. If approved, filgotinib is projected to reach peak sales of nearly $3 billion. Galapagos has a market cap around $5.3 billion of which Gilead already owns 13% under a prior deal. Assuming a 30% premium, an acquisition of Galapagos would only cost around $7 billion in total, barely a dent in Gilead's large wallet. Management has been rather slow when pulling the trigger on these types of deals. But now with dwindling product sales every year, it is crucial that they do something to stop the bleeding.
Een premie van 30% zal niet genoeg zijn om Galapagos-aandeelhouders te overtuigen om akkoord te gaan met een overname door Gilead.
Dat zou een bod betekenen van rond de €110.
Gilead begrijpt, in tegenstelling tot de schrijver van dit artikel, dat z'on bod geen enkele zin heeft.
Wat mij betreft mag een bod uitblijven, als Galapagos zelfstandig blijft zal dat veel meer opleveren voor de aandeelhouders.
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7
Vriendelijk verzoek om de posts zoals vanaf 19 maart voortaan op de Inhoudelijk Light (gestart voor dit soort informatie), Maanddraad of ergens anders te plaatsen. Prima informatie maar niet voor deze draad, die ´we´ zoveel mogelijk schoon willen houden.
thnxs.
[verwijderd]
5
quote:

RW1963 schreef op 19 maart 2018 20:41:

Wie weet toch waar pe26 is gebleven? Al heel lang radiostilte.
100% long Galapagos.

Ik kijk met smart uit naar de vorderingen in programma's Filgotinib, CF, IPF, Eczeem en Artrose.

Zoals eerder gemeld op pagina 2 van het topic "Galapagos: en het topjaar 2018" zullen de nieuwsfeiten zich snel gaan aandienen.

p.s. verder eens met Winx08: houd dit draadje geschoond voor de puur inhoudelijke berichten.
aston.martin
4

In afwachting van verder nieuws kan het interessant zijn om onderstaande patenten eens te lezen.

Het ene gaat over een IRAK-inhibitor, breed inzetbaar bij autoimmuunziekten. Het is echter geen first in class vermits Phizer al een dergelijke molecule in klinische fase 2 heeft.

Het andere patent gaat over een S1P receptor inhibitor. Zelfde toepassingen als de IRAK inhibitor, dus autoimmuunziekten.
Ook hier geen first in class. De meeste moleculen behandelen heel specifiek MS (multiple sclerose). Gilenya van Novartis is reeds op de markt. Ozanimod van Celgene is een andere gekende molecule uit die klasse (de molecule waar Celgene onlangs mee geblunderd heeft).
Galapagos heeft het patent specifiek aangevraagd in het domein van fibrose (maar uiteraard ook tegen andere autoimmuunziekten)
Als ik het goed begrijp is S1P een beetje vergelijkbaar met JAK, in die zin dat er verschillende S1P receptoren zijn net zoals er verschillende JAK moleculen zijn.

worldwide.espacenet.com/publicationDe...

worldwide.espacenet.com/publicationDe...

drulletje drie
0
clinicaltrials.gov/ct2/show/study/NCT...

Van ander draadje maar misschien sneeuwt die daar onder.
Iemand die de moeite wil nemen om te kijken of dit nieuw is ? En of dit positief is?

Zie Cystic Fibrosis (PELICAN) phase 2 maar ....
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1
quote:

drulletje drie schreef op 22 maart 2018 15:28:

clinicaltrials.gov/ct2/show/study/NCT...

Van ander draadje maar misschien sneeuwt die daar onder.
Iemand die de moeite wil nemen om te kijken of dit nieuw is ? En of dit positief is?

Zie Cystic Fibrosis (PELICAN) phase 2 maar ....
Beetje vreemde eerste melding (zoals wel meer vreemd is afgelopen dagen).
De betreffende Pelican trail staat hier nog op recruiting, en er zijn zelfs centra nog niet open, terwijl Galapagos tijdens de 4q17 webcast (22 feb) melde : "The study was quickly fully recruited."
Overigens wordt er op clinical trails gesproken over 22 deelnemers terwijl in de invest pres over 18 wordt gesproken.
Onderstaand overigens de Europese melding:
www.clinicaltrialsregister.eu/ctr-sea...
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0
quote:

winx08 schreef op 22 maart 2018 19:36:

[...]

Beetje vreemde eerste melding (zoals wel meer vreemd is afgelopen dagen).
De betreffende Pelican trail staat hier nog op recruiting, en er zijn zelfs centra nog niet open, terwijl Galapagos tijdens de 4q17 webcast (22 feb) melde : "The study was quickly fully recruited."
Overigens wordt er op clinical trails gesproken over 22 deelnemers terwijl in de invest pres over 18 wordt gesproken.
Onderstaand overigens de Europese melding:
www.clinicaltrialsregister.eu/ctr-sea...
Aansluitend:

»2 maart investor presentation op Galapagos website.

PELICAN
Fully recruited; topline expected Q2 ‘18
Opop
2
Ben benieuwd wat het Arthritis Advies Comité van de FDA op 23 april gaat zeggen over baricitinib van Eli Lilly, kan wel eens invloed hebben op filgotinib:

The discussion will include the following: efficacy, safety, including the risk of thromboembolic adverse events, dose selection, and overall risk benefit considerations.
www.fda.gov/advisorycommittees/calend...

Op 14-4-2017 waren er door de FDA zorgen geuit over de veiligheid van baricitinib waardoor de toelating voorlopig werd geweigerd.
investor.lilly.com/releasedetail.cfm?...

Was toen niet ongunstig voor de koers van GLPG, hierna werden er gelijk nieuwe aandelen uitgegeven.
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5
Piet Wigerinck gaat het over Alzheimer drug discovery hebben.

GT177 Active Compounds Improve Cognition and Biomarkers in Sporadic AD Models

www.neuro4d.com

Lang geleden zocht GLPG een partner om een middel te ontwikkelen met het GT177 target.
NielsjeB
2
ATS 2018 conference, May 18-23 San Diego, CA

May 20, 2018, 11:15 AM - 1:00 PM

A1649 / P1249 - Pharmacodynamics and Pharmacokinetics of the Autotaxin Inhibitor GLPG1690 in the FLORA Trial: A Randomized, Placebo-Controlled, Double Blind Phase IIa Clinical Trial of 12 Weeks in Individuals with Idiopathic Pulmonary Fibrosis

S. Dupont1, J. Desrivot1, J. Ralic2, R. Blanqué1, A. Monjardet1, L. Allamassey3, L. Fagard3, J. Padovan2, B. Heckmann1, O. Van de Steen3, E. van der Aar3, A. Fieuw3;
1Galapagos, Romainville, France, 2Fidelta, Zagreb, Croatia, 3Galapagos, Mechelen, Belgium.

Rationale Idiopathic Pulmonary Fibrosis (IPF) is a chronic and progressive disease with a median survival of 2-5 years after diagnosis. Current drugs slow down disease progression; however the need for more effective and better tolerated therapies remains. GLPG1690 is a novel, potent, and selective small-molecule autotaxin (ATX) inhibitor. ATX is the main enzyme responsible of lysophosphatidic acid (LPA) production in blood. Studies in IPF individuals indicated an increase in LPA levels in the bronchoalveolar lavage fluid, an elevation of LPA 22:4 in exhaled breath condensate, and an increase of ATX levels in human fibrotic lung. The current FLORA trial included pharmacokinetics (PK) and pharmacodynamics (PD) as primary objective. Methods 24 IPF patients were to be randomized (3:1) to GLPG1690 600 mg once daily or placebo for 12 weeks of treatment and 2 weeks follow-up. Blood samples were drawn at baseline, 2 weeks after last dosing and pre-dose over the study, as well as on week 4 (predose, 1.5, 4 and 6 hours (h) post-dosing). Pharmacodynamics was monitored using LPA 18:2 plasma levels and analysed using liquid chromatography with tandem mass spectrometric detection (LC-MS/MS). GLPG1690 plasma levels were determined by LC-MS/MS and PK parameters by non-compartmental analysis using Phoenix WinNonlin. Results 23 patients (17 active, 6 placebo) were randomized. At 4 weeks of treatment, a strong reduction of LPA 18:2 plasma levels post dosing, up to 89±1 % in the GLPG1690 arm was observed, with similar reduction at 1.5h and 6h post dosing. The regulation of LPA 18:2 was sustained with 52±9 and 68±6 % reduction at pre-dose on week 4 and 12, respectively. Full reversibility of the effect was observed at the follow-up visit 2 weeks post treatment. At week 4, the median maximum observed plasma concentration (Cmax) of GLPG1690 was 6.06 µg/mL reached at a median tmax of 4 h. The mean area under the plasma concentration time curve for the dosing interval of 24 hours (AUC0-T) was 55.6 µg.h/mL associated with a trough plasma concentration (CT) of 604 ng/mL being around 4-fold higher than the IC50 in human plasma assay for the reduction of LPA 18:2 (143 ng/mL). Conclusion GLPG1690 induced a fast and sustained reduction in LPA 18:2 plasma levels in IPF patients, indicative for target engagement. Similar pharmacodynamic and pharmacokinetic profiles were previously observed in healthy subjects. The PK and the sustainable PD effect of GLPG1690 support once-daily dosing.

www.abstractsonline.com/pp8/#!/4499/p...

May 20, 2018, 2:45 PM - 3:00 PM

A2436 - A Randomized, Placebo-Controlled, Double Blind Phase Iia Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 12 Weeks of Treatment of an Autotaxin Inhibitor (GLPG1690) in Individuals with Idiopathic Pulmonary Fibrosis (FLORA Trial)

T. M. Maher1, E. van der Aar2, O. Van de Steen3, L. Allamassey2, J. Desrivot4, S. Dupont4, L. Fagard2, F. Ann2, W. Wuyts5;
1Fibrosis Research Group, NHLI, Imperial College, London, London, United Kingdom, 2Galapagos NV, Mechelen, Belgium, 3Galapagos, Mechelen, Belgium, 4Galapagos SASU, Romainville, France, 5University of Leuven, Leuven, Belgium.

Rationale: Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive disease with a median survival of 2-5 years after diagnosis. Drugs currently approved for the treatment of IPF slow disease progression, however, there remains a need for more effective and better tolerated therapies. GLPG1690 is a first-in-class autotaxin inhibitor, which reduces the circulating level of lysophosphatidic acid (LPA), a molecule implicated in the pathophysiology of fibrosis. We report the safety, efficacy and pharmacokinetic (PK) parameters of the trial. Methods: Randomized, placebo-controlled, double blind trial with the aim to randomize (3:1) 24 IPF patients to GLPG1690 600 mg once daily (OD) or placebo for 12 weeks. Subjects were over 40 with non-child-bearing potential. An HRCT performed within 12 months prior to screening visit had to be available. IPF was confirmed by central review. Other inclusion criteria were: FVC >=50% of predicted, Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) >=30% of predicted, FEV1/FVC ratio >=70. The primary endpoint evaluated was safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD). Lung function, functional respiratory imaging, disease biomarkers and quality of life were secondary or exploratory objectives. Results: 23 subjects, 65% male and 39% former smokers with a mean (SE) age 65,6 (1,6) years and Body Mass Index 30,2 (1,2) kg/m², were randomized; 17 to active therapy and 6 to placebo. At screening or baseline, mean time since diagnosis was 1.7 (0,6) years, mean DLCO 38,6 (1,6)%, FVC 2.8 (0,2)L and %predicted FVC 74 (3,4)%. Treatment-emergent adverse events (TEAEs) and discontinuations were similar in the GLPG1690 and placebo group (table). No significant laboratory abnormalities were observed during the trial. Pharmacokinetics resembled healthy volunteer data and support once-daily dosing. FVC showed a progressive decline in the placebo arm, with no decline in the GLP1690 arm on treatment. At 12 weeks the placebo group lost 87 ± 81mL whilst the GLPG1690 group saw a small increase in FVC of 8 ± 50 mL. Conclusion: In this proof of concept study in individuals with IPF, GLPG1690 was generally safe and well tolerated, with apparent disease stabilization compared to placebo based on FVC measurements. These data support the continued assessment of GPLG1690 as a therapy for IPF.

www.abstractsonline.com/pp8/#!/4499/p...
NielsjeB
1
May 22, 2018, 3:45 PM - 4:00 PM

A5928 - Assessment of the Effects of GLPG1690 in Idiopathic Pulmonary Disease (IPF) Patients Using Functional Respiratory Imaging (FRI)

B. Mignot1, W. Vos1, C. Van Holsbeke1, M. Lanclus1, J. De Backer1, A. Fieuw2, P. Ford2;
1FLUIDDA NV, Kontich, Belgium, 2Galapagos NV, Mechelen, Belgium.

Introduction: Diagnosing idiopathic pulmonary disease (IPF) and assessing the effect of compounds is often challenging due to the lack of sensitivity of the current gold standard endpoints such as FVC. Better biomarkers linking regional lung characteristics to clinical outcomes are therefore needed. Functional Respiratory Imaging (FRI) can provide a detailed view of regional lung structure and function, thereby capturing disease heterogeneity in IPF. In a previous study, it was found that an increase in this parameter is related to disease progression.
Aims and objectives: To investigate the effects of the novel selective autotaxin inhibitor GLPG1690 (Galapagos, Belgium) in IPF using FRI.
Methods: This study was an exploratory, randomized, double-blind, placebo-controlled trial investigating a once-daily oral dose of 600mg GLPG1690 in 23 IPF patients. HRCT scans were taken both at baseline and week 12 in 15 patients who received GLPG1690 and 3 who received placebo. FRI was used to look at regional information like airway volume, airway resistance and lobe volume.
Results and interpretation: The results showed that specific airway volume remained constant for the actively treated patients, while it increased in the placebo group. In a previous study, it was found that an increase in this parameter is related to disease progression. The change from baseline for this parameter was significantly different (p=0.0181) between the active (0.08±1.92 mL/L) and the placebo group (3.04±2.38 mL/L). The same results were observed for the specific airway resistance (p=0.0334), with a change of 0.00±0.03 kPas/sec for the active group and a drop of -0.04±0.02 kPas/sec for the placebo group.
Conclusion: This study indicates that FRI is a sensitive tool that enables capturing of clinically relevant disease progression in a regional manner. FRI showed that the novel compound GLPG1690 appears to slow down disease progression in IPF based on FRI data obtained in the study.

www.abstractsonline.com/pp8/#!/4499/p...
Loureiro
0
quote:

*plata o plomo* schreef op 2 april 2018 18:48:

@Nielsje, is dit niet PB-waardig voor Gala?
cws.huginonline.com/G/133350/PR/20170...
GLPG1690 halts disease progression in IPF patients in FLORA Phase 2a trial

09 August 2017 at 22:01 CET
Forced vital capacity (FVC) in lungs stabilized over the 12-week treatment period, placebo arm showed expected decline
Functional respiratory imaging (FRI) confirms FVC data with statistical significance
GLPG1690 was generally well tolerated
First autotaxin inhibitor to show effect in IPF patient trial
GLPG1690 expected to progress to late stage trial
NielsjeB
1
quote:

*plata o plomo* schreef op 2 april 2018 18:48:

@Nielsje, is dit niet PB-waardig voor Gala?
Zoals abelheira al post is dat reeds gebeurd. Voor zover ik in de abstracts kon zien staat er geen nieuwe data in. Die nieuwe data zal bij presentatie van de posters bekend worden. Vermoedelijk komt er rond het begin van de conferentie nog wel een PB om de abstracts aan te kondigen.
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0
quote:

NielsjeB schreef op 2 april 2018 18:53:

[...]
Zoals abelheira al post is dat reeds gebeurd. Voor zover ik in de abstracts kon zien staat er geen nieuwe data in. Die nieuwe data zal bij presentatie van de posters bekend worden. Vermoedelijk komt er rond het begin van de conferentie nog wel een PB om de abstracts aan te kondigen.
Dank je wel Nielsje. Heb ik weer eens niet goed opgelet :-)
Loureiro
2
Nieuws van de grote concurrent van filgotinib : Abbvie.
Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis.

Goed nieuws voor Abbvie wat betreft de werking van de JAK1 maar er is weinig feedback over :
Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established..

Later dit jaar krijgen we info over dezelfde studie met filgotinib?

Abbvie stijgt op dit nieuws met meer dan 3%.
HansGarrincha
0
Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function: enrollment started...
clinicaltrials.gov/ct2/show/NCT03417778
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