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GLPG2737

Phase 2

Cystic Fibrosis | Small molecule | Respiratory |Lakefront Biotherapeutics|Last Updated: Jun 11, 2018

Target and mechanism

ModalitySmall molecule

Also known as GLPG2737 single dose

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

GLPG2737 · 3 trials · 2 indications

Phase 2 1Phase 1 2
NCT03474042GLPG2737 on Top of Orkambi in Subjects With Cystic FibrosisCystic Fibrosis
COMPLETED22 Analytics
PHASE2COMPLETED
GLPG2737 on Top of Orkambi in Subjects With Cystic Fibrosis
Cystic Fibrosis
NCT0347404222
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Study Endpoints

Primary Endpoints

Change from baseline in sweat chloride concentration compared to placebo
Between day 1 pre-morning dose and Day 28.

To assess Change from baseline in sweat chloride concentration compared to placebo.

Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite.
Between day 1 pre-dose and 48 hours post-dose.

To characterize the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.

Time of occurrence of Cmax for GLPG2737(tmax)
Between day 1 pre-dose and 48 hours post-dose.

To determine PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.

Plasma concentration observed at 24 hours post-dos (C24h)
Between day 1 pre-dose and 48 hours post-dose.

To assess PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.

Area under the plasma concentration-time curve for GLPG2737 (AUC0-24h)
Between day 1 pre-dose and 48 hours post-dose.

To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.

Area under the plasma concentration-time curve from time zero until 48 hours post-dose (AUC0-48h)
Between day 1 pre-dose and 48 hours post-dose.

To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.

Terminal plasma elimination rate constant (ke)
Between day 1 pre-dose and 48 hours post-dose.

To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.

Apparent terminal elimination half-life ( t1/2)
Between day 1 pre-dose and 48 hours post-dose.

To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.

Change versus placebo in the proportion of subjects with adverse events
Between screening and 14 days (SAD part) and 15 days (MAD part) after the last dose

To assess safety and tolerability of single and multiple ascending doses with GLPG2737 versus placebo in healthy subjects.

Secondary Endpoints

Change versus placebo in the proportion of subjects with adverse events.
Between Day 1 and 3 weeks after the last dose.
Change from baseline in sweat chloride concentration.
From baseline (pre-morning dose on Day 1) through 28 days.
Change in percent predicted forced expiratory volume in 1 second (FEV1).
From baseline (pre-morning dose on Day 1) through 28 days.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GLPG2737EXPERIMENTALGLPG2737 will be provided as capsules for oral use.
PlaceboPLACEBO_COMPARATORPlacebo will be provided as capsules for oral use.
GLPG2737 single dose.EXPERIMENTALSingle dose of GLPG2737 oral suspension.
GLPG2737 single doseEXPERIMENTALSingle doses of GLPG2737 oral suspension at up to 5 dose levels in ascending order
Placebo single dosePLACEBO_COMPARATORSingle doses of Placebo oral suspension
GLP2737 multiple doseEXPERIMENTALMultiple doses of GLPG2737 oral suspension at up to 3 dose levels in ascending order
GLPG2737 multiple dosePLACEBO_COMPARATORMultiple doses of Placebo oral suspension

Interventions

NameTypeDescription
GLPG2737DRUGGLPG2737 oral capsules administered twice daily for 28 days on top of Orkambi.
PlaceboDRUGPlacebo oral capsules administered twice daily for 28 days on top of Orkambi.
GLPG2737 single doseDRUGGLPG2737 oral suspension, single dose
Placebo single doseDRUGPlacebo, oral suspension.
GLPG2737 multiple doseDRUGGLPG2737 oral suspension, multiple ascending doses, daily for 14 days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Male or female subject ≥18 years of age on the day of signing the ICF. * A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation. * Stable intake of physician prescribed Orkambi (lumacaftor 400 mg/ivacaftor 250 mg b.i.d.) for at least 12 weeks prior t...

Countries:GermanyBelgiumNetherlands
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Competitive Landscape -Cystic Fibrosis 15 trials

Top 5 of 6 competitors

CompanyTickerTrialsLead PhaseDrugs
Vertex Pharmaceuticals IncorporatedVRTX8PHASE3Alyftrek, Trikafta, Ivacaftor, VX-522, VX-272
BiomX Inc.PHGE1PHASE2BX004
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-710
Arcturus Therapeutics Holdings, Inc.ARCT1PHASE2ARCT-032
Krystal Biotech, Inc.KRYS1PHASE1KB407
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