Takeda/CSL’s COVID-19 plasma treatment enters clinical trial with first patient

Pharma News: The CoVIg-19 Plasma Alliance, formed by CSL Behring and Takeda, confirmed that patients are now being enrolled in the Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) Phase III clinical trial.

The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), will evaluate the safety, tolerability and efficacy of an investigational anti-coronavirus hyperimmune intravenous immunoglobulin (H-Ig) medicine for treating hospitalised adults at risk for serious complications of COVID-19 disease. If successful, the Alliance’s H-Ig may become one of the earliest treatment options for hospitalised COVID-19 patients.

This global randomised trial will enrol 500 adult patients at up to 58 sites in the United States, Mexico and 16 other countries on five continents (utilising the NIH’s global INSIGHT Network), who have been hospitalised for COVID-19 and have had symptoms for 12 days or fewer without life-threatening organ dysfunction or end-organ failure.

Patients will receive Gilead’s remdesivir as standard of care, allowing the safety and efficacy of H-Ig to be evaluated when given along with remdesivir treatment. The investigational H-Ig materials for the trial will be provided by CSL Behring and Takeda on behalf of the CoVIg-19 Plasma Alliance, as well as by two other companies.

“The rapid progress we’ve made since we initiated this program just a few months ago to reach this key milestone of enrolling patients in the trial is a powerful testament to the collaboration, determination and innovation taking place across the biomedical community as we work to fight the COVID-19 pandemic,” said Julie Kim, President of Plasma-Derived Therapies Business Unit, Takeda and co-leader of the CoVIg-19 Alliance.

“This study will help us understand how CoVIg-19 could potentially become an important therapeutic option. To support our efforts, we encourage all those people who have recovered from COVID-19 to donate their plasma, which contains vital antibodies that have fought off the disease and could help others do the same.”

“When we created the CoVIg-19 Plasma Alliance in April, the goal was to partner to accelerate our timelines so that we could develop and deliver a reliable and sustainable treatment option for people suffering the impact of COVID-19 and to support countries around the world in their efforts to fight the current pandemic,” said Bill Mezzanotte, MD, MPH, Executive Vice President, Head of Research and Development and Chief Medical Officer, CSL Behring and co-leader of the CoVIg-19 Alliance.

“Thanks to the unprecedented collaboration from the CoVIg-19 Plasma Alliance members, commitment from those who have recovered from the virus and generously chosen to donate their plasma, as well as the strong support from the NIH, we are hopeful that data from the clinical trial will be available before the end of the year. If the trial proves successful, this therapy could bring new hope to those suffering serious health consequences from COVID-19.”

The Alliance, formed by CSL Behring and Takeda, also includes the leading-edge expertise of founding members Biotest, BPL, LFB, and Octapharma, along with additional industry members ADMA Biologics, BioPharma Plasma, GC Pharma, Liminal BioSciences, National Bioproducts Institute and Sanquin. The Bill & Melinda Gates Foundation is providing advisory support. Microsoft is providing technology including the Alliance website and the Plasma Bot for donor recruitment. Organizations including Pall and Uber Health are also making contributions to the CoVIg-19 Plasma Alliance. Experts from the Alliance are collaborating across key aspects such as plasma collection, clinical trial development, and product manufacturing.

Further information about the ITAC trial is available.

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