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Also known as Acumapimod
BCT197 · 4 trials · 3 indications
| Name | Type | Description |
|---|---|---|
| BCT197 | DRUG | - |
| Prednisone placebo | DRUG | capsules |
| BCT197 placebo | DRUG | capsules |
| Prednisone | DRUG | capsules |
| Placebo | DRUG | Capsules will be taken orally with fluids over a 5 day period after randomization |
| Azithromycin | DRUG | 3 daily doses of Azithromycin |
| Itraconazole 200 mg | DRUG | Single dose of itraconazole |
BCT197 has been studied in chronic obstructive pulmonary disease, specifically in patients experiencing acute respiratory exacerbations of COPD. It is a small molecule developed by Mereo BioPharma Group plc. The clinical program includes Phase 2 trials in COPD exacerbations and Phase 1 drug interaction studies in healthy male volunteers.
BCT197 is developed by Mereo BioPharma Group plc, which trades under the ticker MREO. The company has sponsored the clinical development program for BCT197, including Phase 2 studies in COPD exacerbations and Phase 1 drug interaction studies in healthy volunteers.
BCT197 is in Phase 2 development. Its clinical program includes two completed Phase 2 trials in COPD exacerbations and two completed Phase 1 drug interaction studies. BCT197 is investigational and has not been approved by the FDA for any indication.
BCT197 has been evaluated in completed trials including NCT02700919, a Phase 2 study of efficacy and safety in acute respiratory exacerbations of COPD with 282 participants, and NCT01332097, a Phase 2 safety and efficacy study in COPD patients presenting with an exacerbation with 183 participants. Phase 1 interaction studies include NCT03498170 and NCT02926326.
Across its clinical program, 465 participants have been enrolled in BCT197 trials. This includes 282 participants in the Phase 2 COPD exacerbation study NCT02700919, 183 participants in the Phase 2 COPD study NCT01332097, and 16 participants each in the Phase 1 interaction studies NCT03498170 and NCT02926326.
Two completed Phase 1 studies examined how other drugs affect BCT197 exposure in healthy male participants. NCT03498170 evaluated the effect of itraconazole on BCT197 exposure, and NCT02926326 evaluated the effect of azithromycin on BCT197 exposure. Each study enrolled 16 participants.