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GDC-6599 · 1 trial · 5 indications
Cough numbers were assessed by the VitaloJAK semi-automated cough-monitoring system. The VitaloJAK device recorded ambulatory audio for 24 hours from two channels, a lapel microphone (air) and a chest-facing sensor (skin). A software algorithm removed non-cough sounds from the 24-hour audio recordings, compressing the files to less than 10% (on average) of the original length enabling manual analysis to be completed more quickly. The recordings were reviewed by trained Vitalograph analysts who counted individual explosive cough sounds, yielding hourly and 24-hour objective cough count (OCCs). Cough frequency was calculated as the total number of coughs for the full 24 hours recording minus coughs flagged within Mute, Flagged Area, Device Not Attached and Recording Ended Early events divided by the full 24 hours recording minus Mute, Flagged Area, Device Not Attached and Recording Ended Early event time. The standard deviation (SD) reported here is geometric SD.
| Arm | Type | Description |
|---|---|---|
| Part A: CRC Asthma atopic | EXPERIMENTAL | Patients with CRC atopic asthma will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5 |
| Part A: CRC Asthma non-atopic | EXPERIMENTAL | Patients with CRC non-atopic asthma will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5 |
| Part A: Unexplained Chronic Cough | EXPERIMENTAL | Patients with Unexplained Chronic Cough will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5 |
| Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease | EXPERIMENTAL | Patients with Chronic Obstructive Pulmonary Disease will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5. |
| Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis | EXPERIMENTAL | Patients with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5. |
| Name | Type | Description |
|---|---|---|
| GDC-6599 | DRUG | GDC-6599 will be administered Days 1- 14 and on Days 29-42 as film-coated tablets |
| GDC-6599-matching placebo | OTHER | GDC-6599-matching placebo will be administered Days 1- 14 and on Days 29- 42. as film-coated tablets |
| Mannitol | DIAGNOSTIC_TEST | Mannitol challenge tests will be performed during screening and at least 2.5 hours following study drug administration at Study Visits 2, 4, 5 and 7 |
Inclusion Criteria: * Previous diagnosis of CRC, despite optimized treatment for asthma or COPD, or UCC for at least 1 year * Chest X-ray or computed tomography (CT) scan thorax within 5 years prior to screening visit that confirms the absence of any clinically significant abnormality contributing ...
GDC-6599 is an investigational small molecule being studied for chronic refractory cough (CRC) with non-atopic asthma. It is also being evaluated in patients with CRC with atopic asthma, unexplained chronic cough, and CRC with chronic obstructive pulmonary disease, with or without chronic bronchitis.
GDC-6599 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is an investigational small molecule in the respiratory therapeutic area.
GDC-6599 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
GDC-6599 has been studied in one completed Phase 2 trial, NCT05660850, which evaluated its efficacy, safety, pharmacokinetics, and pharmacodynamic effects in patients with chronic cough. The trial enrolled 49 participants across the United States, Australia, Canada, and the United Kingdom.
No alternative names for GDC-6599 have been disclosed. It is identified solely by its code name GDC-6599 in clinical trial records.