Galapagos NV (GLPG - Free Report) announced that the FDA has granted Fast Track designation to its pipeline candidate GLPG1972/S201086 for the treatment of osteoarthritis (OA). GLPG1972/S201086 is already being evaluated in a phase II study (ROCCELLA) conducted by Galapagos and partner Servier to treat knee osteoarthritis patients.
The FDA grants Fast Track designation to expedite development and faster review of a candidate, which is being developed to treat serious and unmet medical conditions. With this designation, a candidate is expected to be granted a priority review, once it files a new drug application.
Galapagos is developing investigational molecule GLPG1972/S201086 with the potential to become a first-in-class disease-modifying osteoarthritis drug (DMOAD).
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 agreement, Galapagos is will receive development, regulatory and other milestone payments along with royalties upon commercialization outside the United States.
Shares of the company have increased 4.4% year to date against the industry’s decline of 17.7%.
Galapagos and Servier initiated the global 52-week ROCCELLA study in June this year. The primary objective of ROCCELLA is to evaluate the efficacy of at least one dose of GLPG1972/S201086 compared to placebo in reducing cartilage loss after 52 weeks of treatment. Galapagos will be responsible for conducting the ROCCELLA study in the United States, where 300 patients are expected to be enrolled. Servier will run the study in all other countries.
In June 2016, the company announced that GLPG1972 was generally well tolerated in healthy human volunteers in a phase I first-in-human study. In this study, dosing with GLPG1972 reduced ARGS neoepitope, a biomarker for cartilage breakdown via the ADAMTS-5 pathway, by up to 60% in these volunteers within two weeks.
In another phase Ib studyin osteoarthritis patients in the United States, similar findings were seen over a four-week period. GLPG1972/S201086 was well tolerated and reduced, in a dose-dependent manner, the ARGS neoepitope blood levels by up to 50%.
We remind investors that Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) are also developing fasinumab for treating OA in late-stage studies. Pfizer (PFE - Free Report) and partner Lilly are also evaluating tanezumab (subcutaneous) in a late-stage study for the treatment of OA pain of the knee or hip.
Galapagos carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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