Galapagos completes patient recruitment for MANGROVE Phase 2 trial with GLPG2737 in polycystic kidney disease
Galapagos NV announces completion of recruitment in the MANGROVE Phase 2 trial with investigational CFTR inhibitor GLPG2737 in patients with autosomal dominant polycystic kidney disease (ADPKD).
MANGROVE is a randomized, double-blind, placebo-controlled trial evaluating a once-daily oral dose of GLPG2737 (NCT04578548). The drug candidate or placebo is administered for 52 weeks, followed by an open-label extension period of 52 weeks, in 66 ADPKD patients with rapidly progressing disease. Patients are randomized in a 2:1 ratio of treatment to placebo. Primary objectives of the trial are to assess the effect on growth of total kidney volume over 52 weeks compared to placebo as well as overall safety and tolerability. Secondary objectives include renal function, pharmacokinetics, and pharmacodynamics. Recruitment for the MANGROVE trial was conducted in 7 countries in Europe.
GLPG2737 is a CFTR (1) inhibitor which was observed to be well tolerated by patients in previous clinical trials. It is hypothesized that inhibition of the CFTR channel might reduce cyst growth and kidney enlargement for patients with ADPKD.
Galapagos expects topline results from the MANGROVE Phase 2 trial in the first half of 2023.
“We thank the ADPKD community for participating in the MANGROVE Phase 2 trial with GLPG2737,” said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos. “Polycystic kidney disease patients have a real need for new therapy options. We hope to learn in 2023 from this trial what CFTR modulation may be able to achieve against ADPKD, in our mission to bring new medicines to kidney disease patients.”
About ADPKD
Autosomal dominant polycystic kidney disease affects approximately 12.5 million people worldwide and is the fourth leading cause of kidney failure today. (2) Typically with this disease, both kidneys enlarge with fluid-filled cysts, leading to kidney failure for approximately half of patients by the age of 60 and requiring dialysis and possibly kidney transplantation. (3) Patients may also suffer from hypertension, abdominal pain, kidney infections, cyst ruptures, bleeding, and other symptoms impacting quality of life. Other organs may be affected as well. Treatment is aimed at relieving symptoms and controlling the accompanying hypertension. Currently, only one therapy (tolvaptan) is available to slow down the progression of cyst development and renal insufficiency; however, not all patients tolerate this therapy. (4)
About Galapagos
Galapagos NV discovers, develops, and commercializes small molecule medicines with novel modes of action. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information is available at www.glpg.com.
(1) Cystic Fibrosis Transmembrane Conductance Regulator
(2) Chebib F.T., Torres V.E. Autosomal Dominant Polycystic Kidney Disease: Core Curriculum 2016. Am J Kidney Dis. May 2016, 67 (5) 792-810
(3) Parfrey P.S., Bear J.C., Morgan J., Cramer B.C., McManamon P.J., Gault M.H., et al. The diagnosis and prognosis of autosomal dominant polycystic kidney disease. N Engl J Med. 1990;323(16):1085–90
(4) Chebib F.T., Perrone R.D., Chapman A.B., Dahl N.K., Harris P.C., Mrug M., et al. A Practical Guide for Treatment of Rapidly Progressive ADPKD with Tolvaptan. JASN. October 2018, 29 (10) 2458-2470