Galapagos completes patient recruitment for MANGROVE Phase 2 trial with GLPG2737 in polycystic kidney disease
November 22 2021 - 4:01PM
Mechelen, Belgium; 22
November 2021,
22.01
CET; Galapagos NV
(Euronext & NASDAQ: GLPG) 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 CFTR1 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 ADPKDAutosomal 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 GalapagosGalapagos 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.
Contacts
Investors:Elizabeth
GoodwinVP Investor Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+1 781 296
1143
Sandra Cauwenberghs Director Investor Relations +32 495 58 46 63
ir@glpg.com
Media:Anna GibbinsSenior Director Therapeutic
Areas Communications+44 7717 801900
Evelyn Fox Director Executive Communications +31 65 3591 999
communications@glpg.com
Forward-looking statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, that are subject to risks,
uncertainties and other factors that could cause actual results to
differ materially from those referred to in the forward-looking
statements and, therefore, the reader should not place undue
reliance on them. These risks, uncertainties and other factors
include, without limitation, the risk that ongoing and future
clinical studies with GLPG2737 may not be completed in the
currently envisaged timelines or at all, the inherent uncertainties
associated with competitive developments, clinical trial and
product development activities and regulatory approval requirements
(including that data from the ongoing and planned clinical research
programs may not support registration or further development of
GLPG2737 due to safety or efficacy concerns or other reasons),
Galapagos' reliance on collaborations with third parties, and that
Galapagos’ estimations regarding its GLPG2737 development program,
regarding the potential value of CFTR inhibition as a mechanism to
treat ADPKD, and regarding the commercial potential of GLPG2737,
may be incorrect, as well as those risks and uncertainties
identified in our Annual Report on Form 20-F for the year ended 31
December 2020 and our subsequent filings with the SEC. All
statements other than statements of historical fact are statements
that could be deemed forward-looking statements. The
forward-looking statements contained herein are based on
management’s current expectations and beliefs and speak only as of
the date hereof, and Galapagos makes no commitment to update or
publicly release any revisions to forward-looking statements in
order to reflect new information or subsequent events,
circumstances or changes in expectations.
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):1085–904 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
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