Galapagos gives R&D update
(Thomson Reuters ONE) -
* Competitive positioning and Phase II study plans in RA for GLPG0634
* Excellent First-in-Human results with GLPG0974 targeting GPR43
* Phase I Proof of Mechanism results of GLPG0492
* Novel antibody shows in vivo Proof of Concept for inflammatory disorders
* New class of compounds discovered in antibacterials
* Dr Piet Wigerinck named Chief Scientific Officer
Webcast presentation today at 12.30 CET/6:30am ET on www.glpg.com
US +1-877-941-6009; Belgium +32-2290-1608; Netherlands +31 20 794 8504
Mechelen, Belgium; 18 April 2012 - Galapagos NV (Euronext: GLPG) will give an
R&D Update later today, indicating progress and plans for its large portfolio of
more than 50 research programs. In addition to laying out the competitive
positioning and Phase II plans for selective JAK1 inhibitor GLPG0634 in
rheumatoid arthritis, a number of other topics will be discussed, including:
Excellent First-in-Human results with GLPG0974
GLPG0974 is an orally available small molecule that reduces migration of
neutrophils, one of the critical cell types in inflammatory processes, by potent
inhibition of GPR43 (also known as FFAR2). Overactivity of neutrophils is a
cause of tissue damage in illnesses such as inflammatory bowel disease, and this
anti-inflammatory mechanism may provide for a novel treatment approach.
GLPG0974 is the first inhibitor of GPR43 to be evaluated clinically. In this
First-in-Human study, healthy volunteers were given increasing single doses of
candidate drug GLPG0974 by oral administration. Encouraging safety data showed
no relevant safety findings, including adverse events, changes in vital signs or
laboratory parameters. The favourable PK profile and the highly significant
changes in neutrophil biomarkers are consistent with once- or twice-daily oral
dosing. Galapagos intends to complete Phase I studies and determine the Phase
II clinical strategy before year end 2012.
Phase I Proof of Mechanism results of GLPG0492
GLPG0492 is an orally available selective androgen receptor modulator (SARM)
which was tested in a Phase I Proof of Mechanism study to assess the effect on
muscle function in healthy volunteers. A biomarker effect similar to that of
Oxandrolone was observed, but the data were insufficient for Galapagos to pursue
GLPG0492 further in cachexia. With the financial support of Charley's Fund and
the Nash Avery Foundation, improvement of muscle strength and running
performance in a pre-clinical model of Duchenne muscular dystrophy (DMD) was
shown with GLPG0492 in 2011. Galapagos intends to discuss with these patient
organizations the opportunity for them to develop GLPG0492 further in DMD.
Novel antibody shows in vivo Proof of Concept for inflammatory disorders
In November 2008, Galapagos and MorphoSys entered an antibody alliance aimed at
discovering and developing antibody therapies based on novel modes of action in
the area of immuno-inflammation disorders. Neutralizing antibodies with high
specificity towards this target have now been tested in two gold standard,
disease-specific in vivo models - rheumatoid arthritis and COPD - and achieved
positive Proof of Concept. A joint program for generation of a fully human
antibody directed against this target has now been initiated. Pre-clinical
candidate selection could be achieved by mid 2013.
New class of compounds discovered in anti-infectives
In the alliance with GSK in anti-infectives, Galapagos discovered a new class of
compounds with a novel mode-of-action by inhibiting DNA polymerase III, an
enzyme essential for bacterial DNA replication. The compounds show activity in
different MRSA in vivo models and thus may offer a new approach to treat
resistant S. Aureus strains, with potential for broader spectrum application.
GSK and Galapagos have ended the anti-infectives alliance, and all assets have
been returned to Galapagos, including the DNA polymerase III mode-of-action
programs.
Appointment of Piet Wigerinck as CSO
Dr Piet Wigerinck has been named Chief Scientific Officer, responsible for all
research and development activities at Galapagos. Dr Wigerinck joined Galapagos
as Senior Vice President Development in April 2008, and was responsible for the
successful Proof-of-Concept study with selective JAK1 inhibitor GLPG0634. As
CSO, Dr Wigerinck will oversee target and drug discovery efforts, in addition to
expanding Galapagos' development department to deliver the Phase II study data
package with GLPG0634. Prior to joining Galapagos, Dr Wigerinck was VP Drug
Discovery, Early Development and CM&C, and a member of the Management Board at
Tibotec (a subsidiary of Johnson & Johnson), where he played a key role in
Tibotec's expansion into novel diseases such as Hepatitis C and advanced several
compounds into Phase I and Phase II clinical trials, including Prezista(®).
Webcast presentation
Galapagos will hold an audio webcast presentation for journalists, analysts, and
investors today at 12:30 pm CET/6:30 am Eastern US, viewable at www.glpg.com.
Call numbers:
Belgium 0800 50747
Netherlands 0800 265 8528
US 1-877-941-6009
Other countries +32 2290 1608 or +31 20 794 8504
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company
specialized in the discovery and development of small molecule and antibody
therapies with novel modes-of-action. The Company is progressing GLPG0634, as
well as one of the largest pipelines in biotech, with four programs in
development and over 50 discovery programs. The Galapagos Group has about 800
employees and operates facilities in six countries, with global headquarters in
Mechelen, Belgium. More info at: www.glpg.com
CONTACT
Galapagos NV
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir(at)glpg.com
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