Corporate Banner
Satellite Banner
Medicinal Chemistry
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 2,900+ scientific posters on ePosters
  • More than 4,200+ 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 Appoints David Smith as CEO of Service Division
David Smith was CFO of Galapagos for two years.
Wednesday, August 21, 2013
Galapagos Discovers Novel Candidate Drug to Treat Breast Cancer
GLPG1790 has high efficacy against triple-negative breast cancer.
Monday, April 22, 2013
Galapagos Acquires Cangenix
Galapagos to add structure-based drug discovery to the Argenta service offering.
Wednesday, January 16, 2013
BioFocus and Ono Sign a Drug Discovery Agreement in the Field of CNS Disorders
BioFocus will use its drug discovery platform to deliver leads and clinical candidates for its client.
Monday, October 08, 2012
Ono and Galapagos Sign an Additional Target Discovery Agreement
Collaboration agreement on discovering novel targets in the field of allergic diseases.
Wednesday, May 30, 2012
Galapagos Delivers Candidate Drug in GSK Alliance
Galapagos NV has announced that it delivered a fourth candidate drug in its arthritis alliance with GlaxoSmithKline (GSK) in December 2010. This achievement triggered a €6.7 million milestone payment to Galapagos, which was included in 2010 revenues.
Friday, March 04, 2011
Galapagos Receives €2.7 Million Grant for Antiviral Drug Discovery
The antiviral programs focus on blocking the activity of a protein in the human body that is essential for a number of important pathogenic viruses to carry out their own reproduction.
Friday, February 18, 2011
Galapagos Receives €4 Million in Milestones from Servier
Servier and Galapagos announced their alliance to develop new medicines for the treatment of osteoarthritis.
Friday, February 18, 2011
Galapagos Receives €7.4 M Milestone in Arthritis Alliance with GlaxoSmithKline
Galapagos completed first-in-human trials for GLPG0555 and initiates clinical Phase I development for a second candidate drug, GLPG0778.
Thursday, January 13, 2011
Galapagos Receives €3.7 Million Grant for Cystic Fibrosis Program
The three-year project focuses on Galapagos' cystic fibrosis program based on novel drug targets to deliver a pre-clinical candidate.
Monday, November 01, 2010
Galapagos' Affiliate BioFocus Extends Collaboration with Chiesi
BioFocus to provide medicinal chemistry and biology services, with an additional option for ADME services, for a Chiesi therapeutic program.
Thursday, October 14, 2010
Galapagos' Affiliate Argenta and Janssen Enter in Integrated Cancer Drug Discovery Service Agreement
Initial phase includes research funding and success-based milestones over five years.
Saturday, October 09, 2010
Galapagos Initiates Phase I Study for JAK inhibitor GLPG0634
Company announces the acquisition of full rights to the compound from GSK.
Monday, August 09, 2010
Galapagos and University of Bristol Enter Drug Discovery Collaboration in Chronic Pain
BioFocus will provide hit-to-lead and lead optimization services for a €3.3 million drug discovery program at the University of Bristol.
Friday, July 16, 2010
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
Scientific News
Keeping Tumor Growth at Bay
Engineers at Washington University in St. Louis found a way to keep a cancerous tumor from growing by using nanoparticles of the main ingredient in common antacid tablets.
Future of Medicine Could be Found in a Tiny Crystal Ball
A Drexel University materials scientist has discovered a way to grow a crystal ball in a lab. Not the kind that soothsayers use to predict the future, but a microscopic version that could be used to encapsulate medication in a way that would allow it to deliver its curative payload more effectively inside the body.
Improving Delivery of Poorly Soluble Drugs Using Nanoparticles
A technology that could forever change the delivery of drugs is undergoing evaluation by the Technology Evaluation Consortium™ (TEC). Developed by researchers at Northeastern University, the technology is capable of creating nanoparticle structures that could deliver drugs into the bloodstream orally – despite the fact that they are normally poorly soluble.
Faster Drug Discovery?
Startup develops more cost-effective test for assessing how cells respond to chemicals.
New Mechanism of Antitumor Action Identified
A team of UAB researchers and collaborators from the Catalan biotech company Ability Pharmaceuticals (UAB Research Park), have described a new mechanism of anti-tumour action, identified during the study and development of the new drug ABTL0812.
Nanoparticles Deliver Tumor Suppressors to Damaged Livers
UT Southwestern Medical Center chemists have successfully used synthetic nanoparticles to deliver tumor-suppressing therapies to diseased livers with cancer, an important hurdle scientists have been struggling to conquer.
Experimental Combination Surprises with Anti-HIV Effectiveness
A compound developed to protect the nervous system from HIV surprised researchers by augmenting the effectiveness of an investigational antiretroviral drug beyond anything expected.
A New Type of Anticancer Agent
Success in the development of a ?-tubulin specific inhibitor.
Nanoparticles Proven Effective Against Antibiotic-Resistant “Superbugs”
In the ever-escalating evolutionary battle with drug-resistant bacteria, humans may soon have a leg up thanks to adaptive, light-activated nanotherapy developed by researchers at the University of Colorado Boulder.
Versatile New Molecule-Building Technique
Chemists at The Scripps Research Institute (TSRI) have devised a new and widely applicable technique for building potential drug molecules and other organic compounds.
SELECTBIO

Skyscraper Banner
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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!