Galapagos « Terug naar discussie overzicht

GLPG1205 en GLPG1690

468 Posts, Pagina: « 1 2 3 4 5 6 7 8 9 10 ... 20 21 22 23 24 » | Laatste
Lama Daila
3
Barclays:

GLPG 1690
At the end of the summer (likely in September), the company will give an update on enrollment in the phase 3 ISABELA trials and should also be able to forecast when it will be able to give the futility analysis of the trial. So far, the trial is going well, though it is the first phase 3 trial the company will be running on its own and is of wide scope; there are 230 sites globally.

Whereas data was shown at EULAR for nintedanib in treating pulmonary function decline associated with systemic sclerosis, GLPG is trialing GLPG 1690 in treating the underlying disease itself (NOVESA phase 2 trial). The trial is small, and GLPG believes there is still a lot to learn in terms of what endpoints the FDA views as important in this indication and should learn more as other assets proceed through the regulatory process.

FatCool
6
Fibrogen gaat eerdaags ook beginnen aan hun fase 3 in IPF:

clinicaltrials.gov/ct2/show/NCT039551...

GLPG1690 ziet er echter veel aantrekkelijker uit dan pamrevlumab:

Approximately 565 eligible subjects will be randomized at a 3:2 ratio to Arm A or Arm B, respectively:
Arm A: pamrevlumab, 30 mg/kg IV Q3 weeks
Arm B: Matching placebo IV Q3 weeks

40% van de patiënten op placebo. 60% op pamrevlumab infuus elke 3 weken voor een totaal van 13 infusen over 48 weken.

Maar wat het zoeken van patiënten vooral moeilijk maakt is: "Inclusion Criteria: No 8 - Not currently receiving treatment for IPF with approved or unapproved therapy."

De afronding van de studie is dan ook voorzien voor maart 2023. En dan is het ook slechts één fase 3 studie na een fase 2 studie met ook maar 90 patiënten. Lijkt me wat magertjes in vergelijking met de GLPG1690 studies met twee maal 750 patiënten.

fc
winx09
0
Gezien de situatie van IPF patiënten, vind ik onderstaande stuk thuishoren in dit draadje. Gevonden op de timeline van @Flosz.


No other interest can take precedence, a patient’s perspective on oncology drug development
twitter.com/myTomorrows/status/114210...

visje2
0
Teleurstelling en kritiek op de strenge patienten selectie voor de Isabela studie op patienten fora.

www.inspire.com/groups/living-with-pu...

Als de interim resultaten in 4e kwartaal goed zijn, wellicht een compassionate toediening voor uitlopend op de eind resultaten.
winx09
1
quote:

visje2 schreef op 7 juli 2019 20:17:


Teleurstelling en kritiek op de strenge patienten selectie voor de Isabela studie op patienten fora.

www.inspire.com/groups/living-with-pu...

Als de interim resultaten in 4e kwartaal goed zijn, wellicht een compassionate toediening voor uitlopend op de eind resultaten.


@Visje2, mij is niets bekend over interim resultaten in 4q. Bedoel je soms de uitspraak dat men in september van plan is wat meer inzicht te bieden over de snelheid van recruitering en verdere voortgang van de studie?

Nu maar hopen, zowel voor de patiënten als voor de snelle voortgang van de studie, dat in alle landen waar de trail loopt patiënten goed georganiseerd en geïnformeerd zijn.
Lama Daila
3
Update van de studielocations:
www.isabelastudies.com/studylocations/

117 centers ondertussen al, mogelijk niet allemaal al recruiting.
Volgens clinicaltrials zijn er 107 recruiting (update 18 juni).
Bijlage:
visje2
0
quote:

winx09 schreef op 8 juli 2019 10:01:


[...]

@Visje2, mij is niets bekend over interim resultaten in 4q. Bedoel je soms de uitspraak dat men in september van plan is wat meer inzicht te bieden over de snelheid van recruitering en verdere voortgang van de studie?

Nu maar hopen, zowel voor de patiënten als voor de snelle voortgang van de studie, dat in alle landen waar de trail loopt patiënten goed georganiseerd en geïnformeerd zijn.


Inderdaad winx glgpen die compassionate toediening werd besproken als een mogelijkheid tijdens de ava van april.
Begrijp de kritische houding van Galapagos om niet direkt alle patienten in de studie te accepteren.
Het leidt evenwel tot veel frustratie bij patienten als ze worden afgewezen, want glpg 1960 wordt door hen gezien als een strohalm voor overleving.

Overigens een prima website over de IPF Isabela studie, die alle informatie tracht te geven.
Patienten snappen echter niet waarom ze worden afgewezen en daar zal toch even meer aandacht aan moeten worden geschonken.
FatCool
0
Op 8 juli een update van NOVESA: in juni er twee ziekenhuizen bij in Italië, één in de USA (nu vijf sites) en één in de UK (nu 2 sites). Met Leuven en drie ziekenhuizen in Spanje brengt dat het totale aantal studie centra op 13. En dat terwijl er slechts 30 patiënten geworven moeten worden.

fc
pe26
5
quote:

Lama Daila schreef op 17 juli 2019 22:30:


Nieuwe update van Isabela trials op CT.
138 sites nu al.




Merci van de update.
Maandelijks 30 klinieken erbij voor de ISABELA IPF-studies en in najaar 2019 heb je dan de 230 klinieken open wat het streven is.

Zeer benieuwd naar officiële update die op komst is.

Op basis van goede berichten (meer USA deelnemers per kliniek dan wat was beoogd), is er gerede kans dat fase 3 studie halfjaar eerder completed is, dan eerder voorzien.

Zeer positieve ontwikkeling!

Ook de quote van Onno 14/7 dat Gilead blinded safety data heeft ingezien doet mij het beste vermoeden.

Gilead was zwaar geïnteresseerd in GLPG1690 en kan nu buiten EU de commercialisatie op zich nemen bij goede Fase 3 data.

avantiavanti
8
SVB Leerink 18 juli 2019

GALAPAGOS NV
BI autotaxin deal further increases our conviction on GLPG1690

Bottom Line: Boehringer Ingelheim chases GLPG in IPF with ATX
licensing deal.

Deal adds to our conviction on scientific approach. Ofev
(nintedanib) owner Boehringer Ingelheim entered a licensing agreement
for Bridge Biotherapeutic’s autotaxin (ATX) inhibitor BBT-887 currently in
Phase 1 trial to treat idiopathic pulmonary fibrosis (IPF). The timing and
potential deal size for a Phase 1 drug by a market leader in idiopathic
pulmonary fibrosis (IPF) raises our conviction in GLPG’s ATX inhibitor
in IPF. Under the terms of the deal, Boehringer Ingelheim will pay €41M
upfront and will owe up to €1.1B in additional development, regulatory
and commercial milestones plus tiered royalties up to low double digits
on future commercial sales. BBT-887 trails the development of GLPG’s
Phase 3 ATX inhibitor GLPG1690 by many years having recently
announced interim data from the single ascending dose portion of the
Phase 1 trial in May at the American Thoracic Society (ATS) conference
held in Dallas, TX. The limited preclinical data presented to date do not
differentiate BBT-887 from GLPG1690 as best in class.

Our Take: There have been lots of questions by investors regarding the
validation and usefulness of targeting the LPA pathway in IPF. We have
previously outlined our enthusiasm for this approach. We
consider the translation work done to identify this pathway as one of the
great translational stories of our time (Tager et al.), which was the basis
for BMS’s acquisition of Amira Pharmaceuticals in 2011. The LPA inhibitor
BMS-986020 demonstrated efficacy as measured by forced vital capacity
(FVC) separation, but was discontinued due to idiosyncratic toxicity
associated with the compound and not the pathway. There has also been
quite a bit of grumbling regarding the rapid progression of GLPG1690
into full blown phase 3, with only a small cohort of patients in hand. The
BMS data, the Fluidda signal, the clear biological signal for GLPG1690
were fundamentally persuasive to move the GLPG management forward
without dithering. The futility readout next year, while increasing the
cost of the study a bit, allows for an early read of the data and further
progression of Isabella. We view the interest from Boehringer Ingelheim,
a respiratory powerhouse and IPF therapeutic pioneer, in autotaxin as a
major validation of GLPG’s commitment to treating IPF by targeting the
LPA pathway.
Beurskingpin
0
quote:

avantiavanti schreef op 19 juli 2019 07:19:


SVB Leerink 18 juli 2019

GALAPAGOS NV
BI autotaxin deal further increases our conviction on GLPG1690

Bottom Line: Boehringer Ingelheim chases GLPG in IPF with ATX
licensing deal.

Deal adds to our conviction on scientific approach. Ofev
(nintedanib) owner Boehringer Ingelheim entered a licensing agreement
for Bridge Biotherapeutic’s autotaxin (ATX) inhibitor BBT-887 currently in
Phase 1 trial to treat idiopathic pulmonary fibrosis (IPF). The timing and
potential deal size for a Phase 1 drug by a market leader in idiopathic
pulmonary fibrosis (IPF) raises our conviction in GLPG’s ATX inhibitor
in IPF. Under the terms of the deal, Boehringer Ingelheim will pay €41M
upfront and will owe up to €1.1B in additional development, regulatory
and commercial milestones plus tiered royalties up to low double digits
on future commercial sales. BBT-887 trails the development of GLPG’s
Phase 3 ATX inhibitor GLPG1690 by many years having recently
announced interim data from the single ascending dose portion of the
Phase 1 trial in May at the American Thoracic Society (ATS) conference
held in Dallas, TX. The limited preclinical data presented to date do not
differentiate BBT-887 from GLPG1690 as best in class.

Our Take: There have been lots of questions by investors regarding the
validation and usefulness of targeting the LPA pathway in IPF. We have
previously outlined our enthusiasm for this approach. We
consider the translation work done to identify this pathway as one of the
great translational stories of our time (Tager et al.), which was the basis
for BMS’s acquisition of Amira Pharmaceuticals in 2011. The LPA inhibitor
BMS-986020 demonstrated efficacy as measured by forced vital capacity
(FVC) separation, but was discontinued due to idiosyncratic toxicity
associated with the compound and not the pathway. There has also been
quite a bit of grumbling regarding the rapid progression of GLPG1690
into full blown phase 3, with only a small cohort of patients in hand. The
BMS data, the Fluidda signal, the clear biological signal for GLPG1690
were fundamentally persuasive to move the GLPG management forward
without dithering. The futility readout next year, while increasing the
cost of the study a bit, allows for an early read of the data and further
progression of Isabella. We view the interest from Boehringer Ingelheim,
a respiratory powerhouse and IPF therapeutic pioneer, in autotaxin as a
major validation of GLPG’s commitment to treating IPF by targeting the
LPA pathway.



Wow! AB! Gaat nog wat geven binnenkort met die futility analysis glpg1690 halfweg 2020.
pe26
5
Dank weer voor het delen Avanti. Prettige analyse van Leerinck.
Galapagos gaat als een speer met GLPG1690, een Autotaxin-inhibitor, binnen ziekte-indicatie IPF.

De licentie die Boehringer Ingelheim neemt op de Autotaxin-inhibitor van Bridge Biotherapeutics duid verder de potentie van dit werkingsmechanisme.

Galapagos heeft een mooie voorsprong van 3 a 4 jaar.

Ik plaats hierbij nog het officiële persbericht van Boehringer Ingelheim.


www.boehringer-ingelheim.com/press-re...


Boehringer Ingelheim Expands Idiopathic Pulmonary Fibrosis (IPF) Pipeline Through Collaboration and License Agreement with Bridge Biotherapeutics

> Boehringer Ingelheim has entered into a collaboration and global license agreement for Bridge Biotherapeutics’s autotaxin inhibitor BBT-877 to be developed for fibrosing interstitial lung diseases including IPF

> With this new partnership Boehringer Ingelheim further expands its commitment to bring new treatments to patients with fibrosing interstitial lung diseases including IPF

> Bridge Biotherapeutics stands to receive up to more than EUR 1.1 billion assuming all milestones are met


Ingelheim, Germany and Seongnam, Korea – 18 July 2019 – Boehringer Ingelheim and Bridge Biotherapeutics Inc. today announced that they are entering into a new collaboration and license agreement with the goal of developing Bridge Biotherapeutics’s autotaxin inhibitor BBT-877 for patients with fibrosing interstitial lung diseases, including IPF. BBT-877 is currently in Phase I clinical studies and is anticipated to enter Phase II testing within the next 12 months.

Both companies will initially focus on developing the compound for the treatment of IPF, an area of high-unmet medical need and one of the key focus areas of Boehringer Ingelheim. Boehringer Ingelheim has developed OFEV® (nintedanib), an antifibrotic drug shown to slow disease progression by reducing lung function decline and currently approved for the treatment of IPF in more than 70 countries around the world including the US, the EU and Japan.

IPF is a rare, debilitating and fatal lung disease affecting approximately three million people worldwide. It causes progressive scarring of the lungs, resulting in continual and irreversible deterioration in lung function and breathing difficulties. BBT-877 inhibits autotaxin, an enzyme mediating a key pro-fibrotic event in multiple cell types. It has shown a promising safety and efficacy profile in pre-clinical models for fibrosing interstitial lung diseases and potential for combination with the current standard of care.

Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit said, “We look forward to working with the team at Bridge Biotherapeutics to develop a new treatment option for patients with IPF. This new collaboration complements our growing pipeline in fibrosing interstitial lung diseases and is a sign of our determination to bring the next generation of treatment options to these patients.”

“Bridge Biotherapeutics is pleased to partner with Boehringer Ingelheim, a recognized leader in IPF. The expertise of Boehringer Ingelheim will ensure that our novel therapeutic candidate can be developed to potentially address unmet medical needs of IPF patients worldwide,” said James Lee, CEO of Bridge Biotherapeutics.

“This is a transformational event for Bridge Biotherapeutics with a total potential value in excess of EUR 1.1 billion. It is a testament to the company’s excellence in the development of novel therapeutics for disease areas with high unmet medical need,” commented B. Chris Kim, PhD, a board member of Bridge Biotherapeutics based in Cambridge, Massachusetts.

Bridge Biotherapeutics will receive upfront and near term payments of EUR 45 million and is eligible to receive up to more than EUR 1.1billion in potential payments based upon the successful achievement of specified development, regulatory, and commercial milestones and staggered, up to double digit royalties.




pe26: vindt het zeer prettig dat Gilead, buiten de EU, de sales gaat doen indien GLPG1690 (Ziritaxestat) naar de markt gaat. Snelle opschaling. Kan Galapagos zich vol op EU richten.


OFEV is currently approved for the treatment of IPF in more than 70 countries around the world including the US, the EU and Japan.


Het is nu een populatie van +200.000 IPF-patiënten die jaarlijks met meer dan 75.000 toeneemt.
Mogelijk dus dat zelfs 3 miljoen mensen te maken met een vorm van littekenweefsel in de longen, waarbij longfuncties heel snel achteruitgaan.

Een verschrikkelijke ziekte.

FatCool
0
quote:

FatCool schreef op 21 juni 2019 20:35:


Fibrogen gaat eerdaags ook beginnen aan hun fase 3 in IPF:

clinicaltrials.gov/ct2/show/NCT039551...

GLPG1690 ziet er echter veel aantrekkelijker uit dan pamrevlumab:

Approximately 565 eligible subjects will be randomized at a 3:2 ratio to Arm A or Arm B, respectively:
Arm A: pamrevlumab, 30 mg/kg IV Q3 weeks
Arm B: Matching placebo IV Q3 weeks

40% van de patiënten op placebo. 60% op pamrevlumab infuus elke 3 weken voor een totaal van 13 infusen over 48 weken.

Kleine correctie: 17 infusen over 48 weken. 40% van de patiënten van deze studie krijgt dus placebo infusen.

De studie van Fibrogen is per 27 juni 2019 officieel begonnen. Met drie recruiterende ziekenhuizen in de VS op dit moment.

fc
Wall Street Trader
0
During the conference call announcing the 10-year partnership with Gilead, GLPG disclosed that unblinded safety data was shared with Gilead prior to partnering. Gilead has rights to GLPG1690 outside Europe, but will still pay $325m milestone if approved in the U.S.

Monotherapy P2a FLORA data supports potential efficacy in any setting, though combination with other IPF drugs may cause unexpected SAEs.

FLORA Ph2a data showed target engagement and favorable safety and tolerability.

There will be a futility analysis in 2020E, based on both safety and efficacy.

The ISABELLA trial design was presented at ATS 2019 (sheet was already posted on the forum by Lama Daila).

www.glpg.com/docs/view/5ce500771f3e3-en

GLPG1690 ISABELA Phase 3 (in IPF) and NOVESA Phase 2 (in systemic sclerosis) trials continue enrolling patients.
The PINTA trial in IPF with GLPG1205 is to finish recruitment by YE19.
It is a 26w-long trial with patients in EU/Mid-East/North Africa (OUS).

We estimate topline data from PINTA in 3Q20.

Pl4
1
quote:

Wall Street Trader schreef op 28 juli 2019 10:31:


During the conference call announcing the 10-year partnership with Gilead, GLPG disclosed that unblinded safety data was shared with Gilead prior to partnering. Gilead has rights to GLPG1690 outside Europe, but will still pay $325m milestone if approved in the U.S.

Monotherapy P2a FLORA data supports potential efficacy in any setting, though combination with other IPF drugs may cause unexpected SAEs.

FLORA Ph2a data showed target engagement and favorable safety and tolerability.

There will be a futility analysis in 2020E, based on both safety and efficacy.

The ISABELLA trial design was presented at ATS 2019 (sheet was already posted on the forum by Lama Daila).

www.glpg.com/docs/view/5ce500771f3e3-en

GLPG1690 ISABELA Phase 3 (in IPF) and NOVESA Phase 2 (in systemic sclerosis) trials continue enrolling patients.
The PINTA trial in IPF with GLPG1205 is to finish recruitment by YE19.
It is a 26w-long trial with patients in EU/Mid-East/North Africa (OUS).

We estimate topline data from PINTA in 3Q20.




I thought I heard them say "blinded safety data.."
Galapapositief
0
quote:

Pl4 schreef op 28 juli 2019 10:53:


[...]

I thought I heard them say "blinded safety data.."

It was blinded safety data. Was mentioned in an article earlier this month aswell
Wall Street Trader
0
@ Pl4 & KomMaarDoor

It was published in the latest analyst Nomura Instinet Report maybe they have heard it wrong.
Bijlage:
Lama Daila
3
seekingalpha.com/article/4279288-gile...

“Moving on to the Galapagos compound, as you might imagine, we looked very carefully at all of the available data in the IPF program. We have quite a bit of experience in IPF ourselves with prior programs at Gilead as well. And we saw that the data really provided the confidence to Galapagos to be able to move ahead and we share that confidence with them.“
468 Posts, Pagina: « 1 2 3 4 5 6 7 8 9 10 ... 20 21 22 23 24 » | Laatste
Aantal posts per pagina:  20 50 100 | Omhoog ↑

Meedoen aan de discussie?

Word nu gratis lid of log in met uw e-mailadres en wachtwoord.

Direct naar Forum

Detail

Vertraagd 25 okt 2021 12:29
Koers 43,500
Verschil -0,370 (-0,84%)
Hoog 43,775
Laag 43,300
Volume 51.827
Volume gemiddeld 366.414
Volume gisteren 619.514

Brussel real time stocks quotedata by Euronext. Other real time EU stocks, by Cboe Europe Ltd.; US stocks by NYSE & Cboe BZX Exchange, 15 min. delayed
#/^ Index indications calculated real time, zie disclaimer, streaming powered by: Infront