Galapagos announces first dosing in MANGROVE Phase 2 trial with GLPG2737 in polycystic kidney disease
December 01 2020 - 4:01PM
Galapagos announces first dosing in MANGROVE Phase 2 trial with
GLPG2737 in polycystic kidney disease
Mechelen, Belgium; 1 December 2020, 22.01 CET; Galapagos
NV (Euronext & NASDAQ: GLPG) 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 CFTR1 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.”
About ADPKDAutosomal dominant
polycystic kidney disease affects approximately 15 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
(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.
For more information about our early clinical programs:
www.glpg.com/other-programsFor information about the studies with
GLPG2737 in ADPKD (NCT04578548): www.clinicaltrials.gov
Contact
Investors:Elizabeth GoodwinVP Investor
Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+32 485 19 14
15ir@glpg.com
Media:Carmen VroonenGlobal Head of
Communications & Public Affairs+32 473 824 874
Anna GibbinsSenior Director Therapeutic Areas Communications+44
7717 801900communications@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, efficacy 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 2019
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 Regulator2 U.S.
Renal Data System. USRDS 2014 Annual Data Report. 20143 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
- Galapagos announces first dosing in MANGROVE Phase 2 trial with
GLPG2737 in polycystic kidney disease'
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