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Annual Report 2020

IVIg to treat critically ill COVID-19 patients

In March 2020, Octapharma created a special project team to confront the disease, joined a coalition with other industry leaders to develop a hyperimmune immunoglobulin therapy, and launched multiple initiatives involving our marketed products. 

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As COVID-19 began to evolve into a global pandemic in 2020, Octapharma moved rapidly to find new ways in which to protect patients and employees. In the space of just a few weeks in March, the company created a special project team to confront the disease, joined a coalition with other leaders in the industry to develop a hyperimmune immunoglobulin therapy, and launched multiple initiatives involving our currently approved and marketed products.

Through these various projects, partnerships and alliances, Octapharma is committed to helping to accelerate the end of the pandemic worldwide.

IVIg to treat critically ill COVID-19 patients

Octapharma supported an investigator-initiated study (IIS) focused on treating the most critical patients – namely those experiencing hypoxemia, being at the highest risk of requiring mechanical ventilation. The research was led by Dr George Sakoulas, MD, at Sharp Memorial Hospital, San Diego, California.

Since its first usage, IVIg has been found to have broad therapeutic applications for the treatment of a variety of inflammatory, infectious, autoimmune and viral diseases. Administration of IVIg solutions not only replaces missing antibodies but also modulates the immune response via multiple mechanisms including blocking a wide array of proinflammatory cytokines that potentially lead to severe inflammatory responses, as well as inhibiting Fc-gamma receptor binding of activated macrophages.

This IIS was the first study to evaluate prospectively the addition of IVIg to otherwise standard of care (SOC) treatment for adults with moderate to severe hypoxemia secondary to COVID-19. In this open label randomised controlled trial, 33 patients were enrolled – 17 patients were randomized to SOC alone and 16 received SOC plus 0.5g/kg IVIg (Octapharma’s intravenous human normal immunoglobulin) per day for three days.

One patient who was part of the trial is 37-year old father of six Eli Centeno who spent 58 days in Sharp Memorial Hospital, including five weeks sedated on a breathing machine. Eli was randomised to not receive IVIG as part of the trial but, with his condition not significantly improving after 36 days on a ventilator, his family approached Dr Sakoulas to prescribe Octapharma’s subcutaneous human normal immunoglobulin. After receiving Octapharma’s IVIg therapy, his oxygen levels slowly improved. “It cut his oxygen requirement down quite a bit and then, next thing you know, he’s getting extubated,” recalls Dr Sakoulas.1

This pilot study showed that IVIg significantly improved hypoxemia and reduced both ICU and hospital length of stay as well as the rate of progression of respiratory failure requiring mechanical ventilation.

“Most of the morbidity and mortality in COVID-19 patients, as well as the burden on healthcare resources, follows the need for mechanical ventilation,” said Dr Sakoulas. “If you can prevent the need for ventilation, the disease becomes much easier to manage at many levels.”

This research has been recently published in the journal “Critical Care Explorations” and was presented at major conferences including the European Society for Immunodeficiencies, the Immunoglobulin National Society and the American Society of Hematology.  

Octapharma also conducted a retrospective data analysis of a COVID-19 patient cohort in Turkey.

FDA approves phase III clinical trial 

In addition to the above study, Octapharma also immediately set up a phase III clinical trial. This large multicentre, randomised, double-blind, placebo-controlled study was approved by the US Food and Drug Administration (FDA) under an Investigational New Drug Application in May 2020.

The primary objective of this study is to determine if high-dose IVIg (Octapharma’s intravenous human normal immunoglobulin) therapy will slow or stop respiratory deterioration in patients with severe COVID-19. The secondary objectives are to measure the effects of high-dose intravenous human normal immunoglobulin on slowing or stopping the clinical deterioration of COVID-19 by improving pulmonary function, quality of life, and correlated impacts on metabolic factors.

The study was launched in the US with enrolling adult patients diagnosed with COVID-19 requiring oxygen supplementation. Total enrolment for the full study is 208 patients; 14 sites in the US have been initiated, with the recent addition of eight more study sites in Ukraine and Russia. The overall enrolment requirement has been achieved and it is expected that the main study results will be submitted to the FDA in the first quarter of 2021.

Wolfgang Frenzel, MD, Head of Research & Development at Octapharma, noted:

“Several case reports of utilising IVIg treatment for COVID-19 patients have shown positive results. We are, therefore, hopeful that we will observe improved clinical status in patients receiving Octapharma’s intravenous human normal immunoglobulin.”

TURKEY: Istanbul University Hospital Study

Octapharma also conducted a retrospective data analysis of a COVID-19 patient cohort in Turkey. The objectives were to compare clinical outcomes and biomarkers in patients with severe COVID-19 treated with SOC alone or in combination with IVIg (Octapharma’s subcutaneous human normal immunoglobulin). This study was conducted under the lead of Prof. Dr Figen Esen, Head of the Intensive Care Department, Istanbul University Hospital, Istanbul.

The data from this retrospective study of 93 critically ill COVID-19 patients shows that IVIg treatment reduces inflammation, which is associated with poor clinical outcomes and death, and points to an increase in both overall survival and a longer survival time. Overall survival was 61% in the IVIg group compared to 38% in the control group. There was also a significantly longer median survival time of 68 days in the IVIg group compared with 18 days in the control group. IVIg significantly reduced levels of C-reactive protein which is a marker of inflammation.

Prof. Dr Esen noted:

“We are happy to see the results of our data leading to further prospective randomised multicentre trials in severely ill COVID-19 patients, and we are really very excited to see the results.”

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