Galapagos Ends Enrollment In Osteoarthritis Study Before Time
Zacks Investment Research | Jun 12, 2019 06:38AM ET
Galapagos NV (NASDAQ:GLPG) announced that it has completed patient recruitment in the phase II study on its pipeline candidate, GLPG1972/S201086, for the treatment of osteoarthritis (OA). The company closed the patient enrollment ahead of the scheduled time.
GLPG1972/S201086 is being evaluated in a phase II study (ROCCELLA) conducted by Galapagos along with France’s Servier to treat patients with knee OA. Last November, the FDA granted a Fast Track designation to this candidate for the given indication.
Galapagos is developing an investigational molecule of GLPG1972/S201086 with potential to become a first-in-class disease-modifying osteoarthritis drug (DMOAD).
Shares of Galapagos have surged 30% so far this year, outperforming the industry’s increase of 1.7%.
Last June, Galapagos and Servier initiated the global 52-week ROCCELLA study. The primary goal of this program is to investigate the efficacy of at least one dose of GLPG1972/S201086 as compared to placebo in reducing the cartilage loss after 52 weeks of treatment, which will be assessed through an MRI. The secondary objectives of the study are to check the safety and tolerability of the candidate with several additional measures of structural progression, pain, function, stiffness and patient global assessment.
Galapagos is looking forward to learn more about the results from this probe sometime next year.
The above-mentioned study enrolled more than 850 patients across 12 countries. Galapagos will be responsible for conducting the ROCCELLA study in the United States where 300 patients are enrolled. Servier will run the analysis in all other countries.
Notably, Galpagos signed a collaboration agreement with Servier for GLPG1972/S201086 in 2010. Galapagos has full U.S. commercial rights to the candidate with Servier retaining the ex-U.S. rights. Per the deal, the company will receive development, regulatory and other milestone payments along with royalties upon commercialization outside the United States.
We remind investors that Pfizer (NYSE:PFE) and partner Lilly (NYSE:LLY) are also evaluating tanezumab (subcutaneous), an investigational monoclonal antibody, in a late-stage study for the treatment of OA pain of the knee or hip.
Apart from OA, Galpagos is intending to foray into the rheumatoid arthritis (RA) market. The company has a partnership with GileadSciences (NASDAQ:GILD) for developing an experimental candidate, filgotinib, for addressing RA. In March this year, both companies announced encouraging interim safety information from four evaluations on filgotinib for the given indication.
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