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Also known as GLPG1837 as, GLPG1837 single ascending doses, GLPG1837 dose 1
GLPG1837 · 2 trials · 1 indication
To evaluate the safety and tolerability of GLPG1837 in terms of adverse events at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal laboratory parameters at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal vital signs as measured by temperature, blood pressure, heart rate and respiratory rate, at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormalities during physical examination at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal electrocardiogram at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal vital signs at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal physical examination at every visit
| Arm | Type | Description |
|---|---|---|
| GLPG1837 dose 1, GLPG1837 dose 2, GLPG1837 dose 3 | EXPERIMENTAL | GLPG1837 twice daily oral dosing - morning and evening, for 4 weeks |
| GLPG1837 dose 1 and GLPG1837 dose 2 | EXPERIMENTAL | GLPG1837 twice daily oral dosing - morning and evening, for 4 weeks |
| Name | Type | Description |
|---|---|---|
| GLPG1837 dose 1 | DRUG | two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week |
| GLPG1837 dose 2 | DRUG | two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week |
| GLPG1837 dose 3 | DRUG | two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for two weeks |
Inclusion Criteria: * Male or female subjects ≥ 18 years of age, with a confirmed diagnosis of cystic fibrosis * Subjects with gating G551D CFTR mutation on at least one allele in the CFTR gene * Subjects currently receiving treatment with ivacaftor on a stable regimen or not on a treatment regimen...
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 |
GLPG1837 is an investigational small molecule being studied for the treatment of cystic fibrosis, a genetic respiratory disease. It is designed for patients whose cystic fibrosis is driven by specific CFTR mutations, including the G551D and S1251N gating mutations. It is not approved and remains in clinical development.
GLPG1837 targets CFTR, the cystic fibrosis transmembrane conductance regulator gene and its protein product. CFTR dysfunction causes cystic fibrosis. GLPG1837 is a small molecule developed to act on CFTR in patients carrying certain mutations, including G551D and S1251N, which are gating mutations that impair chloride transport.
GLPG1837 is being developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company has sponsored Phase 2 clinical studies of the drug in patients with cystic fibrosis. No partnership or licensing arrangement for GLPG1837 is disclosed.
GLPG1837 is in Phase 2 development. Two Phase 2 trials in cystic fibrosis have been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
GLPG1837 has been studied in two completed Phase 2 trials. NCT02707562 enrolled 26 adults with cystic fibrosis and the G551D mutation across Australia, Czechia, Germany, Ireland, and the United Kingdom. NCT02690519 enrolled 7 adults with the S1251N mutation in Belgium and the Netherlands. Both studies are completed.