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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...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 27 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | tilrekimig and rHuPH20, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
GB001 is an investigational small molecule drug developed by Gossamer Bio, Inc. for respiratory conditions. It has been studied in Phase 2 clinical trials in adults with moderate to severe asthma and in adults with chronic rhinosinusitis, including chronic rhinosinusitis without nasal polyps (CRSsNP). It is not an approved therapy.
GB001 was studied as a treatment for adults with moderate to severe asthma. A Phase 2 trial, NCT03683576, enrolled 481 participants across the United States, Austria, Belgium, Canada, Czechia, France, Germany, Poland, Spain, Ukraine, and the United Kingdom. The trial was randomized, double-blind, and placebo-controlled, and it has been completed.
GB001 targets DP2, also known as the prostaglandin D2 receptor 2, a G protein-coupled receptor. DP2 is a receptor target, and GB001 is a small molecule designed to act on it. The asthma and chronic rhinosinusitis trials were biomarker-selected, meaning enrollment was guided by a biomarker.
GB001 is developed by Gossamer Bio, Inc., a biopharmaceutical company whose common stock trades under the ticker GOSS. Gossamer Bio sponsored the Phase 2 clinical program evaluating GB001 in asthma and chronic rhinosinusitis.
GB001 is in Phase 2 development. It is an investigational drug and has not been approved by the FDA. Both of its Phase 2 trials have been completed, and there are no active trials of GB001 currently listed.
GB001 has been evaluated in two completed Phase 2 trials. NCT03683576 studied GB001 in 481 adults with moderate to severe asthma, and NCT03956862 studied GB001 in 97 adults with chronic rhinosinusitis, including chronic rhinosinusitis without nasal polyps (CRSsNP) and with nasal polyps (CRSwNP). Both were randomized, double-blind, and placebo-controlled.