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Also known as GLPG2451 multiple dose, GLPG2451 single dose, GLPG2451 dose regimen A, GLPG2451 dose regimen B
GLPG2451 · 3 trials · 2 indications
To assess safety and tolerability of doses of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I and Part II).
To characterize the pharmacokinetics (PK) of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I and Part II).
To assess changes in sweat chloride concentration after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part II).
To assess changes in percent predicted FEV1 after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part II).
To assess safety and tolerability of multiple ascending doses and combination of GLPG2451 with GLPG2222 versus placebo in healthy subjects
| Arm | Type | Description |
|---|---|---|
| Cohort A - F508del homozygous | EXPERIMENTAL | Dual combination (GLPG2451 and GLPG2222) will be administered for 14 days, followed by the triple combination (GLPG2451, GLPG2222 and GLPG2737) for 14 days, without washout in between the sequential treatment periods.( Study Part I) |
| Cohort B - F508del heterozygous/potentiator nonresponsive | EXPERIMENTAL | Dual combination (GLPG2451 and GLPG2222) will be administered for 14 days, followed by the triple combination (GLPG2451, GLPG2222 and GLPG2737) for 14 days, without washout in between the sequential treatment periods. (study Part II) |
| Cohort C - F508del homozygous | EXPERIMENTAL | Dual combination (GLPG2451 and GLPG2222) will be administered for 14 days, followed by the triple combination (GLPG2451, GLPG2222 and GLPG2737) for 14 days, without washout in between the sequential treatment periods. (Study Part II) |
| GLPG2451 multiple dose | EXPERIMENTAL | Multiple doses of GLPG2451 oral suspension at up to 3 dose levels in ascending order |
| Placebo multiple dose | PLACEBO_COMPARATOR | Multiple doses of Placebo oral suspension |
| GLPG2451/GLPG2222 | EXPERIMENTAL | Multiple doses of GLPG2451 oral suspension combined GLPG2222 oral suspension at up to 2 dose levels |
| Combined Placebo multiple dose | PLACEBO_COMPARATOR | Multiple doses of Combined Placebo oral suspension |
| GLPG2451 single dose | EXPERIMENTAL | Single dose of GLPG2451 oral suspension at up to 4 dose levels in ascending order |
| Placebo single dose | PLACEBO_COMPARATOR | Single dose of Placebo oral suspension |
| Name | Type | Description |
|---|---|---|
| GLPG2451 dose regimen A | DRUG | GLPG2451 oral suspension, daily. |
| GLPG2451 dose regimen B | DRUG | GLPG2451 oral suspension, daily. |
| GLPG2222 | DRUG | GLPG2222 tablet for oral use, daily. |
| GLPG2737 | DRUG | GLPG2737 capsules for oral use, daily. |
| GLPG2451 multiple dose | DRUG | GLPG2451 oral suspension, multiple ascending doses, daily for 14 days |
| Placebo multiple dose | DRUG | Placebo, oral suspension, daily for 14 days |
| GLPG2451/GLPG2222 multiple dose | DRUG | GLPG2451 oral suspension and GLPG2222 oral suspension, multiple doses, daily for 14 days |
| Combined Placebo multiple dose | DRUG | Combined Placebo, oral suspension, daily for 14 days |
| GLPG2451 single dose | DRUG | GLPG2451 oral suspension, single ascending doses, daily |
| Placebo | DRUG | Placebo, oral suspension, daily |
Inclusion Criteria: * Female or male subject ≥18 years of age, on the day of signing the Informed Consent Form (ICF) * Confirmed clinical diagnosis of cystic fibrosis (CF) (documented in the subject's medical record). * Eligible cystic fibrosis transmembrane conductance regulator (CFTR) genotype at...
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| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-522, VX-272 |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |