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GLPG2222 q.d.

Phase 2

Cystic Fibrosis | Small molecule | Respiratory |Galapagos NV|Last Updated: Nov 21, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03045523A Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic FibrosisPHASE2 COMPLETED 37 — — Jan 1, 2017Aug 11, 2017Nov 21, 201722 Australia, Belgium +4
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Study Endpoints
Primary Endpoints
Changes in adverse events
at screening and at each study visit up to day 43 which is the final FU visit

To evaluate the safety and tolerability of GLPG2222 as compared to placebo in terms of adverse events

Changes in abnormal laboratory
at screening and at each study visit up to day 43 which is the final FU visit

To evaluate the safety and tolerability of GLPG2222 as compared to placebo in terms of laboratory

Changes in abnormal vital signs, ECG or physical examination
at screening and at each study visit up to day 43 which is the final FU visit

To evaluate the safety and tolerability of GLPG2222 as compared to placebo in terms of vital signs, ECG or physical examination

Secondary Endpoints
Change from baseline of Sweat chloride concentration
at screening and at each study visit up to day 43 which is the final FU visit
Change from baseline of FEV1 (L) and percent predicted FEV1 for age, gender and height as assessed by spirometry
at screening and at each study visit up to day 43 which is the final FU visit
Change from baseline on the respiratory domain of Revised Cystic Fibrosis Questionnaire (CFQ-R)
at screening and at each study visit up to day 43 which is the final FU visit
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GLPG2222 Dose 1EXPERIMENTAL -
GLPG2222 Dose 2EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
GLPG2222 150 mg q.d.DRUGGLPG2222 150 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days
GLPG2222 300 mg q.d.DRUGGLPG2222 300 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days
PlaceboDRUGPlacebo administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: 1. Male or female subject ≥ 18 years of age, on the day of signing the Informed Consent Form (ICF). 2. A confirmed clinical diagnosis of CF. 3. One F508del mutation on one allele in the CFTR gene, a gating (class III) mutation (one of the following: G551D, G1244E, G1349D, G178R,...

Countries:AustraliaBelgiumCzechiaGermanyIrelandUnited Kingdom
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Competitive Landscape -Cystic Fibrosis 18 trials
CompanyTickerTrialsLead PhaseDrugs
Vertex Pharmaceuticals IncorporatedVRTX9PHASE3VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA, VNZ/TEZ/D-IVA, VX-522 mRNA therapy
Sionna Therapeutics, Inc.SION2PHASE2SION-719, SION-451, SION-2222, SION-109
BiomX LtdPHGE1PHASE2BX004
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-710
Arcturus Therapeutics Holdings, Inc.ARCT1PHASE2ARCT-032
Krystal Biotech, Inc.KRYS1PHASE1KB407
Illumina, Inc.ILMN1 — Undisclosed
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