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Galapagos starts Phase 2A study with GLPG0974 in ulcerative colitis

MECHELEN, BELGIUM -- (Marketwired) -- 04/23/13 -- Galapagos NV (EURONEXT BRUSSELS: GLPG) announced today 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. "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.

About candidate drug 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 FFA2 (free fatty acid receptor 2, formerly known as GPR43). Over-activity of neutrophils is a cause of tissue damage in illnesses such as inflammatory bowel disease. A reduction of neutrophil activation and migration by inhibition of FFA2 may provide for a novel anti-inflammatory treatment approach. By inhibiting FFA2, GLPG0974 prevents free fatty acid-induced activation and migration of neutrophils towards an inflammatory site, such as in the gut of patients with inflammatory bowel disease. GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically. Galapagos expects to report results of the Proof of Concept in early 2014.

About ulcerative colitis

Ulcerative colitis (UC) is one of the idiopathic forms of inflammatory bowel disease (IBD). It is a chronic, relapsing inflammatory disease of the colon, characterized by ulcers in the colon and rectum. Symptoms may include abdominal pain, malnutrition, and diarrhea, often bloody. Ulcerative colitis has a prevalence of 200-250 cases per 100,000 individuals per year and a peak incidence between the ages of 15 and 25 years. This chronic condition is without a medical cure and commonly requires a lifetime of care. Current drug treatment includes anti-inflammatory steroids and immuno-suppressive agents such as TNF inhibitors. Over the long term, up to 25-30% of the patients will require surgery to remove the inflamed parts of the bowels.

About Galapagos

Galapagos (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: GLPYY) is specialized in novel modes-of-action, with a large pipeline of four clinical, seven pre-clinical, and 30 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications.

GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, about to enter Phase 2b studies. AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization after Phase 2b. Galapagos has another selective JAK1 inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012). GLPG0187 is a novel integrin receptor antagonist currently in a Phase 1b patient study in metastasis. GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically for the treatment of IBD; this program is currently in a Proof-of-Concept Phase 2 study.

The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has around 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium. Further information at: www.glpg.com

This release may contain forward-looking statements, including, without limitation, statements containing the words "believes," "anticipates," "expects," "intends," "plans," "seeks," "estimates," "may," "will," "could," "stands to," and "continues," as well as similar expressions. Such forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.

Galapagos starts Phase 2A study with GLPG0974 in ulcerative colitis: http://hugin.info/133350/R/1694918/557530.pdf

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Galapagos NV via Thomson Reuters ONE

[HUG#1694918]

CONTACT

Galapagos NV
Dr Piet Wigerinck
Chief Scientific Officer
Tel. +32 477 627103

Elizabeth Goodwin
Director Investor Relations
Tel: +31 6 2291 6240
Email Contact

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