Corporate Banner
Satellite Banner
Biomolecular Screening
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Galapagos Starts Phase 2A Study with GLPG0974 in Ulcerative Colitis

Published: Tuesday, April 23, 2013
Last Updated: Tuesday, April 23, 2013
Bookmark and Share
Study will deliver topline results early 2014.

Galapagos NV has announced the start of the first Phase 2 clinical study with GLPG0974. This is the third compound from Galapagos' pipeline to enter Phase 2 studies, and its first drug for patients with gastro-intestinal inflammation.

GLPG0974 presents a novel mode of action for the treatment of ulcerative colitis, a debilitating inflammatory bowel disease.

The efficacy and safety of GLPG0974 will be tested in a four-week study with 45 patients and will deliver topline results early 2014.

As a potent inhibitor of FFA2, oral treatment with GLPG0974 aims to reduce migration of neutrophils into the gastro-intestinal tract. Excessive influx of this type of white blood cells damages the bowel tissue and causes chronic inflammation in ulcerative colitis.

The start of the Phase 2 Proof-of-Concept study follows the excellent Phase 1 results with GLPG0974. In healthy volunteers, 2 weeks of once- or twice daily oral dosing was well-tolerated and safe up to the highest doses tested.

A sustained suppression of biomarkers for neutrophil activation demonstrated the desired pharmacodynamic activity.

"We are very excited about the start of the Phase 2 study with GLPG0974. We discovered the role of the FFA2 target in inflammatory diseases, and we developed GLPG0974 as a drug to inhibit FFA2. With this clinical program, we expand our scope from rheumatology to gastroenterology," said Dr Piet Wigerinck, CSO of Galapagos.

Dr Wigerinck continued, "GLPG0974 is the first FFA2 antagonist being evaluated clinically, and we are looking forward to the results in ulcerative colitis patients. If the drug shows efficacy in these patients, this will be an important step, as there is currently no cure for this disease. We expect to report the results of the study in early 2014."

Details of the Phase 2A clinical study
The clinical Proof-of-Concept Phase 2 trial for GLPG0974 will involve 45 patients with mild to moderate ulcerative colitis. The aim is to evaluate the efficacy, effects on selected biomarkers, safety and tolerability and pharmacokinetics of GLPG0974 in this patient population.

Patients with mild to moderate disease will receive either 200 mg of GLPG0974 twice-daily or placebo (2:1 ratio), for a period of four weeks.

This randomized, double-blind, placebo-controlled study will recruit patients in multiple sites in 4 countries: Belgium, Latvia, Czech Republic and Slovakia.

Galapagos has already received approvals to start the trial in Belgium, with patient recruitment starting this month. The trial is anticipated to complete by year end and deliver top line data by Q1 2014.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,000+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Galapagos Initiates a Phase 2a Study with GLPG1690
Company has announced that it has initiated a phase 2a study with GLPG1690 in idiopathic pulmonary fibrosis patients.
Thursday, April 07, 2016
Galapagos Achieves Clinical Proof-of-Mechanism Milestone in GSK Alliance
The company announced that investigational medicine GLPG0778, which is part of its immuno- inflammatory alliance with GlaxoSmithKline, has shown selective effects on a biomarker in a Phase I Proof-of-Mechanism study in healthy volunteers.
Monday, December 19, 2011
NIH Extends Agreement with Galapagos Until End 2012
Galapagos will be eligible to receive up to $8.6 million over the course of the two year extension.
Monday, July 12, 2010
Galapagos Reveals Key Drug Target for Alzheimer's Disease
The data presented in Science article describes how GPR3 was identified in human cells using Galapagos' platform.
Friday, February 13, 2009
Galapagos Announces Achievement of Milestones Totaling €3.2 Million in Osteoarthritis Alliance with GSK
This announcement marks the second and third milestone payments made to Galapagos since the start of the program initiated In June 2006.
Friday, March 30, 2007
Scientific News
It’s Now Easier To Go With The Flow
Rice University tool simplifies comparison of flow cytometry data for laboratories.
FNIH Launches Project to Evaluate Biomarkers in Cancer Patients
Company has announced that it has launched a new project to evaluate the effectiveness of liquid biopsies as biomarkers in colorectal cancer patients.
Drugs that May Combat Deadly Antibiotic-Resistant Bacteria Uncovered
Study identifies 79 compounds that inhibit carbapenem-resistant Enterobacteriaceae (CRE).
Making Precision Medicine a Reality
Researchers are one step closer to understanding the genetic and biological basis of diseases like cancer, diabetes, Alzheimer’s and rheumatoid arthritis – and identifying new drug targets and therapies.
Potential “Good Fat” Biomarker
New method to measure the activity of energy consuming brown fat cells could ease the testing weight loss drugs.
MicroRNA Pathway Could Lead to New Avenues for Leukemia Treatment
Cancer researchers at the University of Cincinnati have found a particular signaling route in microRNA (miR-22) that could lead to targets for acute myeloid leukemia, the most common type of fast-growing cancer of the blood and bone marrow.
Soy Shows Promise as Natural Anti-Microbial Agent
Soy isoflavones and peptides may inhibit the growth of microbial pathogens that cause food-borne illnesses, according to a new study from University of Guelph researchers.
Doubling Down on Dengue
HMS researchers have discovered two ways a compound blocks dengue virus.
Soy Shows Promise as Natural Anti-Microbial Agent
Researchers from University of Guelph show that soy isoflavones and peptides could be used to reduce microbial contamination of food.
AstraZeneca to Sequence 2 Million Genomes in Search for New Drugs
Company launches integrated genomics approach which aims to transform drug discovery and development.
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!