Galapagos NV announces first dosing in the new 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. The drug candidate or placebo will be administered for 52 weeks in up to 60 ADPKD patients with rapidly progressing disease. Patients will be randomized in a 2:1 ratio of treatment to placebo. Primary objectives of the trial are to assess the growth of total kidney volume over 52 weeks compared to placebo as well as overall safety and tolerability. Secondary measures include renal function, pharmacokinetics, and pharmacodynamics. Recruitment for the MANGROVE trial is planned in 7 countries in Europe.
GLPG2737 is a CFTR inhibitor which was shown to be well tolerated by patients in previous clinical trials. It is hypothesized that inhibition of the CFTR channel might reduce cyst growth and enlargement for patients with ADPKD.
“GLPG2737 presents a potential opportunity for us in ADPKD, a disease with significant unmet need,” added Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos. “In MANGROVE we have a clinically meaningful trial that we anticipate will give us new insights into the potential value of CFTR inhibition as a mechanism to treat this serious, rapidly progressing disease.”
Autosomal dominant polycystic kidney disease affects approximately 15 million people worldwide and is the fourth leading cause of kidney failure today. 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. 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.
Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. The company’s pipeline comprises early discovery through to Phase 3 programs in inflammation, fibrosis, and other indications. Galapagos’ ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.
GLPG2737 is an investigational drug and its efficacy and safety have not been established.