Candidate: Gimsilumab

Category: ANTIBODY

Type: Fully human monoclonal antibody targeting granulocyte-macrophage colony stimulating factor (GM-CSF).

Status: On March 27, Roivant’s contract research organization Altasciences said it completed a Phase I trial (NCT04205851) of gimsilumab in patients with or at risk of developing acute respiratory distress syndrome (ARDS). Nine days earlier on March 18, Roivant said it had engaged with regulators in the U.S., Europe, and Asia to rapidly advance clinical development of gimsilumab to treat ARDS associated with SARS-CoV-2. Roivant cited research from Chinese patients showing that GM-CSF is a pro-inflammatory cytokine found to be up-regulated in the serum of COVID-19 patients.

According to Roivant, GM-CSF boosts the expression of pro-inflammatory cytokines such as TNF, IL-6, and IL-23, in addition to promoting the differentiation of Th1/17 cells and the polarization of macrophages to a M1-like phenotype. Gimsilumab has been tested in several non-clinical studies and two clinical studies, including the four-week, 36-patient Phase I study, which evaluated a subcutaneous formulation in healthy volunteers.

Roivant said it will prioritize trials of gimsilumab in patients with COVID-19 instead of a Phase II trial in a separate disease area which had been previously planned.

COVID-19: 200 Candidates and Counting

To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:


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