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GLPG1205 en GLPG1690

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Omlaag ↓

Lama Daila 18 mei 2019 08:46

Galapagos is excited to meet you at #ATS2019 in Dallas,
Friday May 17th – Wednesday May 22nd

galapagosats2019.com/

Posters / Abstracts of interest

Sunday May 19th, 09:15 - 11:15
12902 - Characterization of GLPG1205 in Mouse Fibrosis Models: A Potent and Selective Antagonist of GPR84 for Treatment of Idiopathic Pulmonary Fibrosis.

Sunday May 19th, 14:15 - 16:15
9219 - Autotaxin Inhibitorsin IPF: Elucidation of a Novel Binding Mode for GLPG1690
A108 - Pathophysiology in Diffuse Parenchymal Lung Diseases.

Tuesday May 21st, 09:15 - 16:15
9221 - Rationale, Design and Objectives of Two Phase III, Randomised, Placebo-Controlled Studies of GLPG1690, a Novel Autotaxin Inhibitor, in Idiopathic Pulmonary Fibrosis (ISABELA 1 and 2).

Lama Daila 18 mei 2019 09:14

Galapagos op ATS2019: posters

www.abstractsonline.com/pp8/#!/5789/p...
www.abstractsonline.com/pp8/#!/5789/p...
www.abstractsonline.com/pp8/#!/5789/p...
www.abstractsonline.com/pp8/#!/5789/p...

Lama Daila 18 mei 2019 11:05

Galapagos: Update Isabela trials $GLPG
The Netherlands (ISABELA2) added in clinicaltrialsregister.eu:
www.clinicaltrialsregister.eu/ctr-sea...
Planned number of subjects to be included: 43
Number of sites anticipated in Member State concerned: 6

twitter.com/lama_daila/status/1129673...

[verwijderd] 20 mei 2019 20:18

Updates fase 3 IPF studies, gerund door Galapagos, zijn per 20 mei gemeld.

In totaal nu 86 klinieken open, waarvan 4 in Nederland.

Netherlands

Martini Ziekenhuis Recruiting
Groningen, Netherlands, 9700 RM

Zuyderland Medisch Centrum Recruiting
Heerlen, Netherlands, 6419 PC

St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands, 3425 CM

Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 GD

Verder laat ik het graag aan Lama met zijn strakke overzicht.

Met deze snelheid +200 klinieken open in (na)zomer 2019.

Lama Daila 20 mei 2019 20:51

Inderdaad, hier mijn aangepast overzicht met 84 centers.

Bijlage:

[verwijderd] 20 mei 2019 22:17

quote:
Lama Daila schreef op 20 mei 2019 20:51:
Inderdaad, hier mijn aangepast overzicht met 84 centers.

Mooi!
1 aanvulling:
Bij ISABELA2 zijn er nog 2 Duitse klinieken open gegaan.

Lama Daila 21 mei 2019 07:12

quote:
pe26 schreef op 20 mei 2019 22:17:
[...]

Mooi!
1 aanvulling:
Bij ISABELA2 zijn er nog 2 Duitse klinieken open gegaan.

Inderdaad, die was ik nog vergeten. Ik zal ze nog opnemen. We zitten dus effectief aan 86 centers.

Lama Daila 22 mei 2019 22:56

E-posters GLPG1690 op ATS2019:
cslide-us.ctimeetingtech.com/ats2019_...

Lama Daila 22 mei 2019 23:16

Poster P1036 in PDF-kwaliteit:
users.telenet.be/LamaDaila/Galapagos/...

[verwijderd] 23 mei 2019 09:04

Galapagos heeft groot uitgepakt in Dallas op het ATS 2019 congres.
Meerdere abstracts en aantal Guru sessies. Grote opkomst.

Verder hebben zij programma aangekondigd via galapagosats2019.com/

Best opvallend dat op officiële website er geen persbericht is geweid aan abstracts etc. Wel is het als scientific meeting vermeld.

Enorme blockbuster potentie voor GLPG1690 in IPF/Ssc. Daarnaast nog mogelijke toekomstige combi-opties met andere Galapagos moleculen voor IPF etc.

[verwijderd] 24 mei 2019 23:29

Ziritaxestat

www.medchemexpress.com/GLPG1690.html

www.prescrire.org/Docu/DOCSDCI/WHO_IN... (p. 108)

fc

harvester 26 mei 2019 11:39

MIsschien al gezien door anderen maar Galapagos schakelt dochter Fidelta sinds 12 december 2018 in voor fibrosis discovery onderzoek:

fidelta.eu/fidelta-announces-drug-dis...

Fidelta announces drug discovery agreement with Galapagos
12. December 2018.

12th December 2018

Fidelta announces drug discovery agreement with Galapagos
Zagreb, Croatia, 12th – Fidelta Ltd is pleased to announce that it has signed an integrated drug discovery agreement with Galapagos based on Fidelta’s macrocyclic platform. Under the terms of the agreement, Galapagos will leverage Fidelta’s extensive expertise in macrocyclic drug discovery to further strengthen its fibrosis portfolio.
Adrijana Vinter, Managing Director, Fidelta commented, “Today’s news is a recognition of our know-how in macrocyclic drug discovery, and we are excited to support Galapagos’ efforts in fibrotic research.”
“Fidelta is an undisputed leader in macrocyclic drug discovery, and this transaction could bring considerable new angles to our rapidly expanding efforts in fibrotic research,” said Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos.
About Fidelta
Fidelta, a wholly-owned subsidiary of Galapagos NV, is a fee-for-service, collaborative drug discovery organization that combines expertise in the areas of chemistry, pharmacology, ADME, pharmacokinetics and toxicology. Fidelta offers fully integrated services, as well as flexible stand-alone solutions for projects in discovery and early pre-clinical development. Fidelta has developed a new macrocyclic drug discovery platform, FideltaMacroTM.
Fidelta’s objective is to deliver efficacious, safe and differentiated pre-clinical candidates to its clients. For more information, visit www.fidelta.eu.
More information:
Fidelta d.o.o.
Adrijana Vinter, Managing Director
Tel: +385 1 8886395
fidelta@glpg.com

-----
Dit is bij mijn weten niet door Galapagos gepubliceerd, maar geeft wel aan dat Galapagos alles in het werk stelt om de fibrosis franchise uit te bouwen en geeft wat extra kleur aan het twitter bericht van Onno: "Lets build that franchise" van vlak voor de Dallas conferentie.

Lama Daila 29 mei 2019 12:58

quote:
Lama Daila schreef op 22 mei 2019 23:16:
Poster P1036 in PDF-kwaliteit:
users.telenet.be/LamaDaila/Galapagos/...

Iedereen met interesse in IPF en de Isabela trials zou naast bovenstaande poster ook volgend document eens grondig moeten lezen:
bmjopenrespres.bmj.com/content/bmjres...

Rationale, design and objectives of two phase III, randomised, placebo- controlled studies of GLPG1690, a novel autotaxin inhibitor, in idiopathic pulmonary fibrosis (ISABELA 1 and 2).

Lama Daila 29 mei 2019 13:04

Hier de bijlage in pdf

Bijlage:

Wall Street Trader 29 mei 2019 14:54

Conclusions

GLPG1690, the first ATX inhibitor in clinical development for the treatment of IPF, will be evaluated in two parallel, identically designed, phase III studies (ISABELA 1 and 2) with a 52-week minimum treatment period. For the first time, GLPG1690 will be assessed as an addition to SOC, reflecting potential real-world use. The studies will provide a wide range of clinically relevant data, building on positive clinical findings to date. Positive results may ultimately mean that GLPG1690, alone or in combination, will become a much-needed new treatment option for patients with IPF.

GLPG1690 is still wholly owned by Galapagos.

Design of the ISABELA 1 and 2 studies. D, day; EoSA, end-of-study assessment; EoST, end-of-study treatment; FU, follow-up; qd, once daily; V, visit; W, week.

Bijlage:

harvester 30 mei 2019 00:08

Clinical studies of GLPG 1690 and BG00011 pulmonaryfibrosisnews.com/forums/foru...

harvester 30 mei 2019 00:10

[quote alias=harvester id=11623971 date=201905300008]
Clinical studies of GLPG 1690 and BG00011 pulmonaryfibrosisnews.com/forums/foru...
[/quote:

Ene Danny schrijft:

Both of these studies are recruiting right now, One at the Cleveland Clinic and one at the University of Michigan. I have a pulmonologist at each hospital and will be getting into one of them. Both drugs did very well in original testing and both almost stop signals that cause scarring and minor or no side effects on healthy volunteers. Much better then OFEV and Esbriet! If anyone can get in on one you should do it. I will be doing the GLPG 1690 at U of M

Lama Daila 16 juni 2019 11:42

Griekenland is nog toegevoegd op clinicaltrialsregister.eu:
Gepland aantal patienten: 37
Gepland aantal centers: 5
Merk op dat voor Spanje en Frankrijk blijkbaar alle geplande centers al recruiting zijn.
In bijlage nog eens het aangepaste overzicht.

Bijlage:

[verwijderd] 16 juni 2019 19:22

Qua chemie de concurrent met min of meer hetzelfde werkingsmechanisme:

Bridge Biotherapeutics Announces Data Presentation from First-in-Human Study of BBT-877 for Idiopathic Pulmonary Fibrosis

Postive Interim Results from Ongoing Phase 1 Trial Presented at ATS 2019

May 20, 2019 - Bridge Biotherapeutics Inc., a clinical-stage biotech company developing novel therapeutics for areas with high unmet medical needs, announced that the company presented interim data from a Phase I clinical study on BBT-877, a drug candidate for treatment of idiopathic pulmonary fibrosis (IPF), at the American Thoracic Society International Conference (ATS 2019) held in Dallas, Texas from May 17-22.

Interim pharmacokinetic and safety results from the randomized, double-blind, placebo-controlled, Phase I study were included in a poster “BBT-877, a potent Autotaxin Inhibitor in Clinical Development to Treat Idiopathic Pulmonary Fibrosis” presented on May 19, during the Pathophysiology in Diffuse Parenchymal Lung Diseases poster session.

In the single-ascending dose (SAD) portion of the study, plasma concentrations of BBT-877 increased with dose in a dose-proportional manner. All doses demonstrated safety and tolerability, with only mild adverse events (AEs) and no serious AEs. Furthermore, there were no clinically related findings in safety assessments of the study, such as electrocardiogram, vital sign, laboratory biochemical/hematological profile, and urinalysis results.

“We remain highly focused on the clinical development of BBT-877,” said Gwang-hee Lee, PhD, Vice President, Head of Translational Research at Bridge Biotherapeutics. “BBT-877 has shown potential as a best-in-class ATX inhibitor for treatment of IPF with favorable results in the first-in-human, clinical study. These findings reinforce our continued collaborations with world-class pulmonologists specializing in IPF.”

The Phase I study of BBT-877 (ClinicalTrials.gov Identifier: NCT03830125) is expected to be finalized by August 2019, and a multinational Phase II study is planned to be conducted in the U.S., Canada, Australia, and multiple countries in Europe and Asia.

Preclinical research of BBT-877 has demonstrated its potency and in vivo efficacy as an ATX inhibitor and best-in-class potential. These interim clinical data contribute to the BBT-877 safety and tolerability demonstrated to date and support the continued development of BBT-877 for treatment of IPF.

The original file of the poster presented at the ATS 2019 is available at bridgebiorx.com/upload/pdf/71eba4a326...

Lama Daila 18 juni 2019 18:45

Nieuwe update van de ISABELA trials op clinicaltrials.
107 centers recruiting momenteel.
Nieuwe landen: België, Chili, UK en Zuid-Afrika.

Bijlage:

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