Publication date: 27/11/2018
Galapagos NV (Euronext & NASDAQ: GLPG) announced today that the FDA has granted GLPG1972/S201086 Fast Track designation for the treatment of patients with osteoarthritis (OA).
The US Food and Drug Administration's (FDA's) Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious or life-threatening diseases or conditions and that demonstrate the potential to address unmet medical needs. Drugs that receive this designation are eligible for more frequent interactions with the FDA and are potentially eligible for priority review and rolling review of a New Drug Application (NDA). The purpose of this FDA program is to get important new drugs to patients earlier.
Galapagos is developing investigational molecule GLPG1972/S201086 with the potential to become a first-in-class disease-modifying osteoarthritis drug (DMOAD) as part of a collaboration with Servier signed in 2010. Galapagos has full US commercial rights to GLPG1972/S201086, with Servier retaining the ex-US rights. Under the terms of the agreement, Galapagos is also eligible to receive development, regulatory and other milestone payments plus royalties upon commercialization outside the US. In June 2018, Galapagos and Servier announced the start of the global 52-week ROCCELLA Phase 2 trial with GLPG1972/S201086 in knee osteoarthritis patients.
"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," said Dr. Walid Abi-Saab, CMO of Galapagos. "Together with our collaboration partner Servier, we look forward to accelerating the development of GLPG1972/S201086 as a potential first disease-modifying osteoarthritis drug."
GLPG1972/S201086 is a DMOAD candidate targeting a cartilage-degrading enzyme called ADAMTS-5, as confirmed in two animal models. A Phase 1 trial in healthy volunteers met all its safety and pharmacokinetic targets and also demonstrated that within two weeks, GLPG1972/S201086 reduced the blood level of ARGS neoepitope, a biomarker for cartilage breakdown, by approximately 50%. In a more recent Phase 1b trial in osteoarthritis patients in the United States, similar findings were seen over a four-week period. Specifically, GLPG1972/S201086 was well tolerated and it reduced, in a dose-dependent manner, the ARGS neoepitope blood levels by up to 50%.
GLPG1972/S201086 is an investigational drug, and its efficacy and safety have not been established.
For more information about GLPG1972/S201086: www.glpg.com/glpg-1972.
About the ROCCELLA trial
ROCCELLA is a multiregional, randomized, double-blind, placebo-controlled, dose ranging trial evaluating the efficacy and safety of three different once-daily oral doses of GLPG1972/S201086 in patients with knee osteoarthritis. ROCCELLA is planned to recruit approximately 850 patients in up to 15 countries. Galapagos will be responsible for ROCCELLA in the United States, where 300 patients are intended to be recruited. Servier will run the trial in all other countries.
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. Cartilage thickness will be measured using quantitative magnetic resonance imaging of the central medial tibiofemoral compartment of the target knee. Secondary objectives include safety and tolerability, several additional measures of structural progression, changes in bone area, pain, function, stiffness, and patient global assessment.
For information about the study with GLPG1972/S201086: www.clinicaltrials.gov (NCT03595618).
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Galapagos' pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, osteoarthritis and other indications. Our target discovery platform has delivered three novel mechanisms showing promising patient results in, respectively, inflammatory diseases, idiopathic pulmonary fibrosis and atopic dermatitis. Our ambition is to become a leading global biopharmaceutical company, focused on the development and commercialization of innovative medicines that will improve people's lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 700 employees, operating from its Mechelen, Belgium headquarters and facilities in the Netherlands, France, Switzerland, the US and Croatia. More information at www.glpg.com.