Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GLPG2222 single dose, GLPG2222 q.d
GLPG2222 · 3 trials · 2 indications
Number of participants with any treatment-emergent adverse events (TEAEs) and serious or treatment-related TEAEs, as well as number of patients with TEAEs by worst intensity reported (mild, moderate, or severe).
To evaluate the safety and tolerability of GLPG2222 as compared to placebo in terms of adverse events
To evaluate the safety and tolerability of GLPG2222 as compared to placebo in terms of laboratory
To evaluate the safety and tolerability of GLPG2222 as compared to placebo in terms of vital signs, ECG or physical examination
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiogram
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal pulmonary function as measured by spirometry
| Arm | Type | Description |
|---|---|---|
| Cohort A: GLPG2222 50 mg once daily (QD) | EXPERIMENTAL | Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets orally, QD for 29 days. |
| Cohort A: GLPG2222 100 mg QD | EXPERIMENTAL | Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets orally, QD for 29 days. |
| Cohort B: GLPG2222 200 mg QD | EXPERIMENTAL | Participants received two GLPG2222 100 mg tablets and one matching placebo tablet orally, QD for 29 days. |
| Cohort B: GLPG2222 400 mg QD | EXPERIMENTAL | Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days. |
| Cohort A Placebo | PLACEBO_COMPARATOR | Participants received three matching placebo tablets, orally, QD for 29 days. |
| Cohort B Placebo | PLACEBO_COMPARATOR | Participants received three matching placebo tablets, orally, QD for 29 days. |
| GLPG2222 Dose 1 | EXPERIMENTAL | - |
| GLPG2222 Dose 2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| GLPG2222 single dose | EXPERIMENTAL | Single dose of GLPG2222 oral suspension |
| Placebo single dose | PLACEBO_COMPARATOR | Single dose of placebo oral suspension |
| GLPG2222 multiple doses | EXPERIMENTAL | Multiple doses of GLPG2222 oral suspension |
| Placebo multiple doses | PLACEBO_COMPARATOR | Multiple doses of placebo oral suspension |
| Name | Type | Description |
|---|---|---|
| GLPG2222 50 mg | DRUG | Oral tablet(s) containing GLPG2222 |
| GLPG2222 100 mg | DRUG | Oral tablet(s) containing GLPG2222 |
| Placebo | DRUG | Matching oral tablet(s) containing placebo |
| GLPG2222 200 mg | DRUG | Oral tablet(s) containing GLPG2222 |
| GLPG2222 400 mg | DRUG | Oral tablet(s) containing GLPG2222 |
| GLPG2222 150 mg q.d. | DRUG | GLPG2222 150 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days |
| GLPG2222 300 mg q.d. | DRUG | GLPG2222 300 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days |
| GLPG2222 single dose | DRUG | single ascending doses, oral suspension |
| Placebo single dose | DRUG | single doses, oral suspension, matching placebo |
| GLPG2222 multiple doses | DRUG | multiple ascending doses, daily for 14 days, oral suspension |
| Placebo multiple doses | DRUG | multiple doses, daily for 14 days, oral suspension, matching placebo |
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 and homozygous for the F508del CFTR mutation 3. Weight ≥ 40 kg. 4. Stable concomitant treatment for at least 4 weeks (28 days) prior to bas...
Top 5 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| 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 |