News

Kiniksa announces results from phase III trial of mavrilimumab in COVID-19-related ARDS.

Read time: 1 mins

Published:3rd Jan 2022

Kiniksa Pharmaceuticals, Ltd. announced that the Phase III portion of the Phase II/III trial of mavrilimumab in COVID-19-related acute respiratory syndrome (ARDS) did not meet the primary efficacy endpoint.

Mavrilimumab is an investigational fully human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRalfa). The Phase II/III trial is a global, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of mavrilimumab for the treatment of hospitalized, non-mechanically-ventilated adult patients with hypoxia and severe COVID-19 pneumonia/hyperinflammation.

A total of 582 patients in the Phase III portion of the trial were randomized in a 1:1:1 ratio to receive a single intravenous dose of mavrilimumab 10 mg/kg, 6 mg/kg, or placebo. The Phase III portion of the trial did not meet its primary efficacy endpoint of proportion of patients alive and free of mechanical ventilation at Day 29.

Condition: Coronavirus/ARDS

Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Related news and insights

Drug news

Veru Inc., reaches agreement with FDA on a new phase III clinical trial for sabizabulin for broader indication: hospitalized adult patients with any type of viral acute respiratory distress syndrome (ARDS).

Veru Inc. announced that in a September 21, 2023 meeting, the Company and FDA reached agreement on the design of a new Phase III clinical trial study to evaluate sabizabulin plus standard of care treatment in an expanded patient population, hospitalized adult patients who have broadly any type of virus causing ARDS

1 mins

Drug news

Request for EUA for sabizabulin to treat hospitalized COVID-19 patients at high risk for ARDS is not accepted by FDA - Veru Inc.,

Veru Inc. announced that the FDA has declined to grant at this time the Company’s request for Emergency Use Authorization (EUA) for sabizabulin, Veru’s novel microtubule disruptor, to treat hospitalized adult patients with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome (ARDS).

1 min

Drug news

Update on FDA Advisory Committee Meeting regarding Emergency Use Authorization of sabizabulin to treat hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome

Veru Inc. announces the results of the meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC), which reviewed sabizabulin for Emergency Use Authorization (EUA) in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome (ARDS)

1 min

See all news