Our fifth treatment area is osteoarthritis: GLPG1972 presents a unique opportunity

Sometimes called degenerative joint disease or degenerative arthritis, osteoarthritis, or OA, is the most common chronic condition of the joints. OA can affect any joint, but it occurs most often in the small joints of the fingers, knees, hips, lower back and neck, and the bases of the thumb and big toe1Source: www.arthritis.org. According to a November 2015 GlobalData EpiCast Report, OA will be the fourth leading cause of disability by the year 2020. There are limited data on the total prevalence of OA, but as an example, in the 7 major markets in 2014 the diagnosed prevalence of hand OA was over 60 million patients. In normal joints, a firm, rubbery material called cartilage covers the end of each bone. Cartilage provides a smooth, gliding surface for joint motion and acts as a cushion between the bones. In OA, the cartilage breaks down, causing pain, swelling and problems moving the joint. As OA worsens over time, bones may break down and develop growths called spurs. Bits of bone or cartilage may chip off and float around in the joint. In the body, an inflammatory process occurs and cytokines (proteins) and enzymes develop that further damage the cartilage. In the final stages of OA, the cartilage wears away and bone rubs against bone leading to joint damage and more pain17.

Although OA occurs in people of all ages, osteoarthritis is most common in people older than 65. Common risk factors include obesity, previous joint injury, over use of the joint, and weak thigh muscles. One in two adults in the United States will develop symptoms of knee OA during their lives. One in four American adults will develop symptoms of hip OA by age 85. One in 12 people 60 years or older have had OA17. Current treatments for OA include weight loss, physical therapy, pain and anti-inflammatory medicines, and surgery, all of which address only the symptoms of the disease. There currently are no approved disease-modifying therapies available.

In November 2015, we announced that GLPG1972, a first-in-class candidate drug aimed at treating OA, had been dosed in a Phase 1 First-in-Human study. GLPG1972 has a novel mode of action with potential application in osteoarthritis, and was discovered by us under our collaboration agreement with Servier, an independent French-based pharmaceutical company. Galapagos earned a €3.5 million milestone payment from Servier in connection with this achievement.

The aim of the Phase 1 study is to evaluate the safety, tolerability, and pharmacokinetics of oral single and multiple ascending doses of GLPG1972. The randomized, double-blind, placebo-controlled, single center study is being conducted in at least 40 healthy volunteers in Belgium. In the first part of the study, single ascending doses will be evaluated. In the second part, the new compound will be administered daily for 14 days in multiple ascending doses. Topline results from this Phase 1 study along with other data resulting from the ongoing program expected in the second quarter of 2017 will enable our partner Servier to exercise or not the option to license the compound for further development into osteoarthritis patient trials. Galapagos also expects to initiate a patient study in osteoarthritis patients in Q2 2016. Galapagos has retained full rights to the compound in the United States.

1 Source: www.arthritis.org