Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as KIN-1901
Gimsilumab · 2 trials · 3 indications
"Incidence" is defined as the percent of subjects that died by Day 43
| Arm | Type | Description |
|---|---|---|
| Gimsilumab | EXPERIMENTAL | Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 |
| Placebo | PLACEBO_COMPARATOR | Normal saline on Day 1 Normal saline on Day 8 |
| KIN-1901 | EXPERIMENTAL | Single or repeat (once weekly for 4 weeks) KIN-1901 subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Gimsilumab | DRUG | Gimsilumab is a fully human monoclonal antibody (mAb). |
| Placebo | DRUG | Normal saline |
| KIN-1901 | DRUG | KIN-1901 is a fully human monoclonal antibody (mAb). |
Inclusion Criteria: 1. Male or non-pregnant female age ≥18 years, inclusive 2. Subject (or legally authorized representative) is able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form 3. Has laboratory-conf...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
Gimsilumab is an investigational monoclonal antibody developed by Roivant Sciences Ltd. (ticker ROIV) for the treatment of COVID-19. It was studied in patients with lung injury or acute respiratory distress syndrome secondary to COVID-19. It is a Phase 2 candidate and has not been approved by the FDA.
Gimsilumab was studied for lung injury or acute respiratory distress syndrome secondary to COVID-19. The Phase 2 BREATHE trial enrolled 227 participants aged 18 years and older in the United States. Gimsilumab remains investigational and is not an approved treatment for COVID-19.
Gimsilumab targets CSF2, also known as granulocyte-macrophage colony-stimulating factor (GM-CSF). It is an inhibitor of this target, meaning it is designed to block CSF2 signaling. This mechanism was the basis for studying gimsilumab in inflammatory lung injury associated with COVID-19.
Gimsilumab is being developed by Roivant Sciences Ltd., which trades under the ticker ROIV. Roivant sponsored the Phase 2 BREATHE study of gimsilumab in COVID-19 patients with lung injury or acute respiratory distress syndrome.
Gimsilumab is in Phase 2 development. Its only registered trial, the BREATHE study, was a Phase 2 trial that has been completed. Gimsilumab is investigational and has not been approved by the FDA for any indication.
Gimsilumab was evaluated in one clinical trial, NCT04351243, also called the BREATHE study. This completed Phase 2 trial tested gimsilumab in 227 participants with lung injury or acute respiratory distress syndrome secondary to COVID-19. It was randomized, double-blind, and placebo-controlled, and enrolled patients in the United States.