FDA Fast Track Designation Granted for Investigational Osteoarthritis Treatment
The US Food and Drug Administration (FDA) has granted Fast Track designation for GLPG1972/S201086 for the treatment of patients with osteoarthritis (OA).
The investigational molecule is a disease-modifying OA drug candidate that targets a cartilage-degrading enzyme called ADAMTS-5. Data from a phase 1 trial demonstrated that within 2 weeks, GLPG1972/S201086 reduced the blood level of ARGS neoepitope by approximately 50%. Similar findings were seen over a 4-week period in a Phase 1b trial including patients with OA from the United States. The treatment was well tolerated and reduced the ARGS neoepitope blood levels by up to 50%.
The ROCCELLA trial (ClinicalTrials.gov identifier: NCT03595618) will also evaluate the efficacy and safety of 3 different once-daily oral doses of GLPG1972/S201086. About 850 patients will be recruited from 15 countries. The primary end point of the ROCCELLA trial is to evaluate the efficacy of at least 1 dose of GLPG1972/S201086 compared with placebo in reducing cartilage loss after 52 weeks.
"The Fast Track designation by the FDA is a recognition of the high unmet medical need in OA, and the potential of GLPG1972/S201086 as a new treatment option," stated Walid Abi-Saab, MD, CMO of Galapagos, in a press release. "Together with our collaboration partner Servier, we look forward to accelerating the development of GLPG1972/S201086 as a potential first disease-modifying osteoarthritis drug."
Galapagos noteed that GLPG1972/S201086 is an investigational drug, and the efficacy and safety have not been established.
Galapagos receives Fast Track designation from FDA for GLPG1972/S201086 in osteoarthritis [press release]. Mechelen, Belgium: Galapagos. http://www.glpg.com/press-releases. Published November 27, 2018. Accessed November 27, 2018.