Approval Probability
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Also known as GLPG2222 single dose, GLPG2222 q.d
GLPG2222 · 2 trials · 1 indication
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
| 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 | - |
| 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 |
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 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-272, Tezacaftor |
| 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 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
GLPG2222 is an investigational small molecule being studied for the treatment of cystic fibrosis, a genetic respiratory disease. It has been evaluated in Phase 2 clinical trials in adults with cystic fibrosis, including a study in patients already receiving ivacaftor. It is not approved for any use.
GLPG2222 targets CFTR, the cystic fibrosis transmembrane conductance regulator gene. CFTR dysfunction is the underlying cause of cystic fibrosis. By acting on this target, GLPG2222 is designed as a small molecule therapeutic for the disease, and it has been studied in biomarker-selected cystic fibrosis patients.
GLPG2222 is being developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company has sponsored the clinical development program for the drug in cystic fibrosis, including two completed Phase 2 trials in adult patients.
GLPG2222 is in Phase 2 clinical development. Two Phase 2 trials have been completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA for cystic fibrosis or any other indication.
GLPG2222 has been studied in two completed Phase 2 trials: NCT03119649, which evaluated multiple doses in 59 adults with cystic fibrosis across the United States, Belgium, Netherlands, Serbia, Spain, and the United Kingdom, and NCT03045523, which evaluated GLPG2222 in 37 ivacaftor-treated cystic fibrosis subjects in Australia, Belgium, Czechia, Germany, Ireland, and the United Kingdom.