Canadian Altasciences completes its Phase I study on Gimsilumab to prevent and treat acute respiratory distress syndrome (ARDS) in COVID-19 patients.
Gimsilumab Phase I study for ARDS in COVID-19
Altasciences, a forward-thinking, mid-size Canadian CRO specialising in providing comprehensive early-stage drug development, announced on March 27, that it has completed a Phase I clinical study for the development of Gimsilumab.
Gimsilumab is a fully human monoclonal antibody targeting the granulocyte-macrophage colony stimulating factor (GM-CSF), found to be up-regulated in SARS CoV-2 patients with or at risk of developing acute respiratory distress syndrome (ARDS). GM-CSF is a cytokine implicated in many autoimmune disorders that acts as a pro-inflammatory signal, prompting macrophages to launch an immune cascade that ultimately results in tissue damage.
Roivant prioritises Gimsilumab trial
Swiss pharmaceutical company Roivant Sciences, announced on March 18, that they will be prioritising clinical trials of Gimsilumab in patients with COVID-19, rather than a previously planned Phase 2 trial in a different disease area. Roivant Sciences stated that the clinical trials of Gimsilumab patients with COVID-19 will begin once it is approved by the relevant regulatory authorities.
Gimsilumab shows promise for ARDS in COVID-19
The Gimsilumab treatment has been associated with a favourable safety and tolerability profile to date. New clinical data from China, in COVID-19 patients, indicates that GM-CSF contributes to immunopathology caused by SARS CoV-2 in patients with or at risk of developing ARDS. ARDS is a severe COVID-19 complication that requires hospitalisation and mechanical ventilation or other life support interventions.
Riovant’s press release highlights that the percentages of GM-CSF-expressing CD4+ T cells (Th1), CD8+ T cells, NK cells, and B cells have been observed to be significantly higher in the blood of ICU-admitted COVID-19 patients when compared with healthy controls. The reported immunological changes also appear to be more pronounced in ICU-admitted COVID-19 patients versus non-ICU COVID-19 patients.
Dr. Elizabeth Volkmann, founder and co-director of the UCLA Connective Tissue Disease-Related Interstitial Lung Disease Program stated:
“Up-regulation of GM-CSF appears to characterize progression to ARDS and death in COVID-19…”
“Targeting GM-CSF represents a promising strategy for curbing lung damage while allowing time for the virus to clear. It is my hope that gimsilumab will reduce mortality from COVID-19 and help improve the lives of those affected by this emerging public health crisis.”
Ingrid Holmes, Vice President, Global Clinical Operations at Altasciences stated:
“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”
Altasciences, which collaborated with Roivant Sciences on this important development, is an innovative contract research organization offering pharma and biotech companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.
Chris Perkin, Chief Executive Officer at Altasciences says:
“The team at Altasciences is proud to contribute in developing potentially lifesaving 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.”
More about Altasciences
Founded in 1992, Altasciences has been collaborating with sponsors for more than 25 years to help support better educated, agile, and more comprehensive 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 customisable to the specific requirements of their sponsors.