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GLPG2737

Phase 2

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

GLPG2737 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Mar 2018

GLPG2737 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_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment28

FDA Designations

No designations recorded

GLPG2737 clinical trials

GLPG2737 · 2 trials · 1 indication

Phase 2 1Phase 1 1
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 FibrosisUnlock trial analytics

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.

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.

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
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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:GermanyBelgium
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Competitive Landscape -Cystic Fibrosis 20 trials

Frequently asked questions about GLPG2737

What is GLPG2737?

GLPG2737 is an investigational small molecule developed by Lakefront Biotherapeutics (ticker LKFT) for cystic fibrosis, a respiratory disease. It has been studied as an oral therapy in Phase 2 and Phase 1 clinical trials, including a Phase 2 study in which it was given on top of Orkambi in adults with cystic fibrosis.

What is GLPG2737 used for in cystic fibrosis?

GLPG2737 is being developed for cystic fibrosis, a genetic respiratory disease. Its clinical trials enrolled adults with cystic fibrosis, including a Phase 2 study of GLPG2737 added on top of Orkambi and a Phase 1 pharmacokinetics study in male subjects with cystic fibrosis. It is investigational and has not been approved.

Who makes GLPG2737?

GLPG2737 is developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company has sponsored the clinical studies of GLPG2737 in cystic fibrosis, including the Phase 2 trial of GLPG2737 on top of Orkambi and a Phase 1 pharmacokinetics trial.

What phase is GLPG2737 in?

GLPG2737 is in Phase 2 development for cystic fibrosis. Two trials have been completed: a Phase 2 study of GLPG2737 on top of Orkambi and a Phase 1 pharmacokinetics study. No trials are currently active. GLPG2737 is investigational and has not been approved by the FDA.

What clinical trials is GLPG2737 in?

GLPG2737 has been studied in two completed cystic fibrosis trials. NCT03474042 was a Phase 2 trial of GLPG2737 on top of Orkambi in 22 adults, conducted in Germany. NCT03450720 was a Phase 1 pharmacokinetics trial in 6 male subjects, conducted in Belgium. Both trials are completed.

Is GLPG2737 the same as GLPG2737 single dose?

Yes, GLPG2737 single dose is another name used for GLPG2737, the investigational small molecule developed by Lakefront Biotherapeutics (ticker LKFT) for cystic fibrosis. Searches for either name refer to the same compound and the same clinical development program.