Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GB001 · 2 trials · 3 indications
The SNOT-22 is a validated questionnaire to assess the impact of chronic rhinosinusitis (CRS) on quality of life and utilizes a 2-week recall period. It is a 22-item outcome measure on a 5-point category scale applicable to sinonasal conditions and surgical treatments. The total scores range from 0 to 110 with higher total scores implying greater impact of CRS on quality of life.
Proportion of participants who experience worsening of asthma by Week 24 as defined by at least 1 of the following: * On 2 consecutive days, morning (AM) peak expiratory flow (PEF) ≤ 75% of mean AM PEF measured over the last 7 days of the Run-in * Forced expiratory volume in 1 second (FEV1) \< 80% of baseline * Increase in rescue medication use of ≥ 6 puffs/day on 2 consecutive days compared to mean use over the last 7 days of the Run-in * Increase in Asthma Control Questionnaire 5 (ACQ-5; see Outcome Measure 2 for description) score of ≥ 0.5 compared to baseline * The occurrence of a severe asthma exacerbation (asthma attack) defined as deterioration of asthma that leads to the use of systemic corticosteroids for at least 3 days, hospitalization, or an Emergency Department visit.
| Arm | Type | Description |
|---|---|---|
| GB001 | EXPERIMENTAL | GB001 40 mg once per day (QD) for 16 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo QD for 16 weeks |
| GB001 20 mg | EXPERIMENTAL | GB001 20 mg QD for 24 weeks |
| GB001 40 mg | EXPERIMENTAL | GB001 40 mg QD for 24 weeks |
| GB001 60 mg | EXPERIMENTAL | GB001 60 mg QD for 24 weeks |
| Name | Type | Description |
|---|---|---|
| GB001 | DRUG | film-coated oral tablet |
| Placebo | DRUG | film-coated oral tablet |
Inclusion Criteria: * A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic rhinosinusitis without nasal polyps (CRSsNP) by a physician at least 12 weeks before Screening Visit * Treated with stable intranasal corticosteroid (INCS) for at least 2 months prior to Screening Visi...
GB001 is an investigational small molecule being developed for respiratory conditions, specifically moderate to severe asthma and chronic rhinosinusitis without nasal polyps (CRSsNP). It has been studied in Phase 2 clinical trials for these indications.
GB001 is being developed by Gossamer Bio, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol GOSS.
GB001 is in Phase 2 clinical development. It has completed Phase 2 trials for asthma and chronic rhinosinusitis, but it is not yet approved and remains an investigational drug.
GB001 has been studied in two completed Phase 2 trials: NCT03683576 for moderate to severe asthma with 481 participants, and NCT03956862 for chronic rhinosinusitis with 97 participants. Both trials were randomized, double-blind, and placebo-controlled.
GB001 is the primary name for this investigational drug. No alternative names have been reported for it in clinical trial registrations or development disclosures.