Altasciences has finalised a Phase I study for the development of gimsilumab, up-regulated in SARS CoV-2 in patients with or at risk of developing acute respiratory distress syndrome (ARDS).

Gimsilumab is a fully human monoclonal antibody that targets granulocyte-macrophage colony-stimulating factor (GM-CSF).

Roivant Sciences recently announced “they will prioritise trials of gimsilumab in patients with Covid-19 instead of a Phase 2 trial in a separate disease area which had been previously planned. Clinical trials of gimsilumab patients with Covid-19 will commence upon approval by relevant regulatory authorities.” Gimsilumab treatment has been associated with a favourable safety and tolerability profile to date.

Emerging clinical evidence in Covid-19 patients suggests that GM-CSF contributes to immunopathology caused by SARS CoV-2 in patients with or at risk of developing ARDS. ARDS is a serious complication of Covid-19 which necessitates hospitalisation and mechanical ventilation or other life support measures.

“We are proud to have collaborated with Roivant Sciences on this important development, which may help ease the suffering of patients afflicted by Covid-19, as well as other ARDS patients in need of therapy,” says Ingrid Holmes, Vice President, Global Clinical Operations at Altasciences.

Altasciences is a forward-thinking, mid-sized contract research organisation offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

“The team at Altasciences is proud to contribute in developing potentially life-saving therapies to combat Covid-19. We are experiencing unprecedented times and it is humbling to see the research community come together to make a difference,” says Chris Perkin, CEO at Altasciences.

For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements.

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