Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as KPL-301, CAM3001
mavrilimumab · 4 trials · 7 indications
Number of subjects alive and off of oxygen
Number of subjects alive and off of oxygen
Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation. The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation. The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.
Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.
Time to flare by Week 26 was defined as time from randomization to the date of first flare occurring within the 26-week period, as assessed by independent adjudication. Kaplan-Meier method used to estimate the survival functions for each treatment arm. Flare/relapse was defined as a C-reactive protein (CRP) of 1 mg/dL or greater and/or erythrocyte sedimentation rate (ESR) of 30 mm/h or greater AND at least one of the following signs or symptoms attributed to GCA: Cranial symptoms (new-onset localized headache; scalp or temporal artery tenderness; ischemic-related vision loss; unexplained mouth or jaw pain upon mastication; transient ischemic attack or stroke related to GCA); Extracranial symptoms (claudication of the extremities; symptoms of polymyalgia rheumatica); New or worsening angiographic abnormalities detected via MRI, CT/CTA, or PET-CT of the aorta or other great vessels or via ultrasound of the temporal arteries.
| Arm | Type | Description |
|---|---|---|
| Intervention | ACTIVE_COMPARATOR | Treatment infusion |
| Control | PLACEBO_COMPARATOR | Placebo infusion |
| Mavrilimumab | EXPERIMENTAL | Mavrilimumab Treatment infusion |
| Placebo | PLACEBO_COMPARATOR | Placebo infusion |
| 10 mg/kg (Cohort 1) | ACTIVE_COMPARATOR | Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion |
| 6 mg/kg (Cohort 1) | ACTIVE_COMPARATOR | Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion |
| Placebo (Cohort 1) | PLACEBO_COMPARATOR | Non-mechanically ventilated participants administered placebo as a single IV infusion |
| 10 mg/kg (Cohort 2) | ACTIVE_COMPARATOR | Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion |
| 6 mg/kg (Cohort 2) | ACTIVE_COMPARATOR | Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion |
| Placebo (Cohort 2) | PLACEBO_COMPARATOR | Mechanically ventilated participants administered placebo as a single IV infusion |
| Name | Type | Description |
|---|---|---|
| Mavrilimumab | DRUG | Treatment infusion |
| Placebos | DRUG | Placebo infusion |
| Placebo | DRUG | Placebo infusion |
| prednisone | DRUG | Prednisone tablets for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone United States Pharmacopeia (USP) |
Inclusion Criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Documented COVID19 pneumonia defined as positive SARS-CoV2 test AND abnormalities/ infiltrates on chest x-ray or computed tomography AND active fever or documented fever within 24-48 hours or ongo...
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| 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 |
Mavrilimumab is an investigational monoclonal antibody developed by Kiniksa Pharmaceuticals International, plc. It has been studied in clinical trials for COVID-19 pneumonia with hyper-inflammation and for giant cell arteritis. It is a Phase 2 candidate and has not been approved by the FDA.
Mavrilimumab has been studied in giant cell arteritis and in COVID-19, including COVID-19 pneumonia with systemic hyper-inflammation. Both programs reached Phase 2. The completed trials enrolled adults, with the giant cell arteritis study requiring participants aged 50 years or older.
Mavrilimumab targets CSF2RA and CSF2RB, the alpha and beta subunits of the GM-CSF receptor. It acts as an antagonist, blocking GM-CSF receptor signaling. This mechanism was the basis for studying it in conditions driven by systemic hyper-inflammation, such as giant cell arteritis and severe COVID-19 pneumonia.
Mavrilimumab is developed by Kiniksa Pharmaceuticals International, plc, which trades on Nasdaq under the ticker KNSA. The company has advanced the asset, also referred to as KPL-301, through Phase 2 clinical development in giant cell arteritis and COVID-19.
Mavrilimumab is in Phase 2 development. It is investigational and has not been approved by the FDA. All four recorded trials were Phase 2 studies, and all have completed, with no active trials currently listed for the program.
Mavrilimumab has completed four Phase 2 trials. NCT03827018 tested KPL-301 in giant cell arteritis with 70 participants. NCT04447469 studied it in hospitalized COVID-19 patients with 814 participants. NCT04492514 and NCT04463004 also evaluated it in COVID-19 pneumonia and hyper-inflammation.
Yes, KPL-301 is an alternative designation for mavrilimumab. Kiniksa Pharmaceuticals uses the KPL-301 name in its giant cell arteritis trial, NCT03827018, which is titled KPL-301 for Subjects With Giant Cell Arteritis. Searches for either name refer to the same monoclonal antibody asset.