Business Wire

Octapharma Reports Positive Data from octagam® Usage in Critically Ill COVID-19 Patients

Share

Topline results from a retrospective study in 93 critically ill COVID-19 patients have become available. The data shows that IVIG treatment reduces inflammation, which is associated with poor clinical outcomes and death, and points to an increase in survival, in critically ill COVID-19 patients, when compared to a control group. The study was conducted at the Istanbul University Hospital, Turkey, under the lead of Prof. Dr. Figen Esen.

In critically ill COVID-19 patients, the cause of death often implicates an abnormal pulmonary immune response. This abnormal immune response is characterized by high levels of inflammatory markers, which are associated with poor clinical outcomes.1, 2 Acute respiratory distress syndrome (ARDS) and multiorgan failure are major causes of mortality in COVID-19 patients.3 High levels of pro-inflammatory cytokines and chemokines are part of a severe inflammatory response known as a “cytokine storm” which may cause multiple organ dysfunction and ARDS in critically ill COVID-19 patients.4

There is no known effective treatment for patients infected with COVID-19, except for remdesivir and dexamethasone.

Early treatment of COVID-19 patients with systemic immune modulators such as IVIG may reduce aberrant immune responses and the subsequent inflammatory responses, which are observed in the severe stages of ARDS and may cause lasting lung damage and death.5, 6

IVIG has been proven to protect from infections in immunodeficient patients and has also been increasingly recognized for its immunomodulatory and anti-inflammatory effects. Although the mechanisms of action of IVIG are not completely understood, it may modulate the immune response via multiple mechanisms, including blocking a wide array of pro-inflammatory cytokines that potentially lead to severe inflammatory responses, including cytokine storm, as well as Fc-gamma receptor binding of activated macrophages)4.

Octagam® (5% and 10%) is a polyvalent IVIG preparation that is approved in over 80 countries worldwide for the treatment of immunodeficiency and other immune disorders.

It is hypothesized that octagam® can treat critically ill COVID-19 patients by reducing and/or preventing hyperinflammation as it has been observed in severe disease.4

In the Istanbul University Hospital study, octagam® 5% was administered at approx. 0.4g/kg body weight for 5 consecutive days (2g/kg body weight total dose) to 51 critically ill COVID-19 patients, all requiring intensive care with intubation and mechanical ventilation. Biomarkers and clinical outcomes were compared with those of 42 critically ill COVID-19 patients who did not receive IVIG. Other treatments used in both treatment groups included favipiravir, hydroxychloroquine, azithromycin, oseltamivir, tocilizumab, and anakinra.

A higher survival rate was observed in the octagam® treatment group. At the end of the study, overall survival was 60.8% in the treatment group which received octagam®, versus 38.1% in the control group which did not receive IVIG (p = 0.0906 after controlling for baseline factors), corresponding to a trend of 2.2 times reduced risk of death when receiving IVIG.

At 6 days after start of treatment, the inflammatory marker C-reactive protein (CRP) was significantly reduced by 46% versus baseline in the IVIG group, whereas there was no reduction compared to baseline in the control group (p=0.0488).

Prof. Dr. Figen Esen, Head of the Intensive Care Department, Istanbul University Hospital, commented: “In the critical care setting, the management of sepsis includes modulation of the immune system and the host response. Whilst IVIG treatment in sepsis has shown positive beneficial effects in terms of infection and lowering inflammation and mortality, the relatively small amount of data generated from high quality clinical trials has prevented its widespread incorporation into clinical guidelines.

The clinical picture of severe COVID-19 in the critical care setting includes many of the same features as sepsis, however with a much more severe inflammatory chaos induced by cytokine storm. There is one other difference; here we do not have any proven effective treatments, apart from manipulating the patient’s immune system, either by augmenting or suppressing.

IVIG therapy presents a perfect choice to modulate the patient’s immune system and calm down the situation. Although our results have certain limitations, we have observed in routine clinical use of IVIG in severely ill COVID-19 patients, a significant reduction in inflammation in the group receiving IVIG treatment, leading to an improved clinical outcome in terms of a much higher survival rate.

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

“These positive results from Istanbul University Hospital appear to demonstrate the immune-modulating properties of IVIG in severely-ill COVID-19 patients, in reducing hyperinflammation and the associated cytokine storm syndrome and improving clinical outcomes”, said Wolfgang Frenzel, M.D., Head of Research & Development at Octapharma. “We are hopeful of further positive results in our ongoing Phase 3, multicenter clinical trial on the efficacy and safety of octagam® 10% therapy in COVID-19 patients with severe disease progression, currently being conducted at a number of study sites in the USA”.

These results from Istanbul University Hospital contribute to a growing body of clinical evidence suggesting the role IVIG plays in increasing survival and improving clinical outcomes in critically ill COVID-19 patients, by preventing and/or reducing hyperinflammation and the associated cytokine storm syndrome.

Following on from this positive data from Istanbul University Hospital and also a prospective investigator-initiated study conducted by Dr George Sakoulas of Sharp Memorial Hospital in San Diego, USA), Octapharma has started a Phase 3, multicenter clinical trial on the efficacy and safety of octagam® 10% therapy in COVID-19 patients with severe disease progression.

This study is currently being conducted in various centers in the United States and compares the efficacy and safety of IVIG plus standard of care (SOC) versus placebo in the treatment of COVID-19 patients at risk of requiring mechanical ventilation.

Information about Octagam® 5%

Octagam® 5% is a ready to use, liquid preparation of highly purified immunoglobulin for intravenous administration (IVIG). It was originally approved in Europe in 1995, and is now approved in over 80 countries worldwide for the treatment of primary and secondary immunodeficiencies and a variety of other immune disorders. It is approved as immunomodulation therapy in immune thrombocytopenia (ITP), Guillain-Barré syndrome (GBS) and Kawasaki disease, chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN) in selected geographical areas.

About Octapharma

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy, and Critical Care.

Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, with a combined capacity of approximately 8 million litres of plasma per annum. In addition, Octapharma operates more than 140 plasma donation centres across Europe and the US.

For further information on the action of Octapharma in the fight against COVID-19 see this article.

References

1. Tisoncik JR, Korth MJ, Simmons CP, Farrar J, Martin TR, Katze MG. Into the eye of the cytokine storm. Microbiology and molecular biology reviews : MMBR 2012; 76(1) 16-32. https://www.ncbi.nlm.nih.gov/pubmed/22390970

2. Lee KY. Pneumonia, Acute Respiratory Distress Syndrome, and Early Immune-Modulator Therapy. International journal of molecular sciences 2017; 18(2). https://www.ncbi.nlm.nih.gov/pubmed/28208675

3. Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020; 46: 846-848. https://pubmed.ncbi.nlm.nih.gov/32125452/

4. Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. https://pubmed.ncbi.nlm.nih.gov/32192578/

5. Calabrese LH. Cytokine storm and the prospects for immunotherapy with COVID-19. Cleveland Clinic journal of medicine 2020. https://www.ncbi.nlm.nih.gov/pubmed/32393592

6. Wright DJM. Prevention of the cytokine storm in COVID-19. The Lancet Infectious diseases 2020. https://www.ncbi.nlm.nih.gov/pubmed/32386610

Contact information

Macarena Guillamon
corporatecommunications@octapharma.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Ipsen Appoints Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer25.9.2020 08:00:00 EESTPress release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005822/en/ Philippe Lopes-Fernandes, Executive Vice President, Chief Business Officer, Ipsen (Photo: Business Wire) Ipsen (Euronext: IPN; ADR: IPSEY) today announced the appointment of Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer, effective 1 October 2020. Based in Cambridge, Massachusetts, USA, he will be responsible for business development and alliance management, reporting directly to David Loew, CEO, Ipsen. Philippe will serve on the Executive Leadership Team. “As Chief Business Officer, Philippe will play a crucial role in our external innovation strategy. The ELT and I are delighted to welcome Philippe to Ipsen and look forward to working closely with him. His extensive and impressive track record in international business development, his outstanding reputation and his ability to work closely with the scientific comm

Deloitte Launches < "The Next Wave" Emerging Digital Life in South and Southeast Asia > Report At Ant Group’s INCLUSION Fintech Conference25.9.2020 06:45:00 EESTPress release

Deloitte launched <"The Next Wave" Emerging Digital Life in South and Southeast Asia > Report today at the INCLUSION Fintech Conference, organized by Ant Group and Alipay to foster a global dialogue on building a more inclusive, green, and sustainable world through digital technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005941/en/ (Graphic: Business Wire) Through an extensive survey conducted across age groups in eight countries in South and Southeast Asia, specifically Singapore, Malaysia, Thailand, Indonesia, the Philippines, India, Bangladesh and Pakistan, the report showed that consumers aged between 21 and 40 years old are the leading force enabling the rapid adoption of a digital life in the region in the post Covid-19 world. Speaking at one of the media forums on Day 2 of INCLUSION, Taylor Lam, Technology, Media & Telecommunications Industry Leader at Deloitte China, said: “Young and vibrant economies

Science, Data, and Facts Should Unite Decision-Making, Says PMI CEO in Speech at Concordia Summit24.9.2020 22:20:00 EESTPress release

André Calantzopoulos, CEO of Philip Morris International (PMI) (NYSE: PM), today delivered high-level remarks at the 2020 Concordia Annual Summit. Calantzopoulos discussed the impact that uncertainty, polarization, hyperpartisanship, and ideology are having on international efforts to overcome pressing global issues. He called for science to be protected from politicization and highlighted the importance of developing open dialogues based on factual scientific objectivity. Calantzopoulos shared PMI’s belief that with the right regulatory encouragement and support from civil society, cigarette sales can end within 10 to 15 years in many countries. The Concordia Annual Summit, which coincides with the United Nations General Assembly (UNGA) meeting, convenes the world’s most prominent business, government, and nonprofit leaders to foster dialogue and enable effective partnerships for positive social impact. Excerpts of the remarks by André Calantzopoulos follow: “Reflecting on the state o

Swiss Medical Group Holding Acquires CoreMedica Europe24.9.2020 18:54:00 EESTPress release

Swiss Medical Group (SMG) Holding Luxembourg S.A., leading the development of STARKS Age-Management in Europe and Asia, announced today the acquisition of CoreMedica Europe, to expand in Europe and the rest of the world. CoreMedica Europe recently made the headlines in Switzerland for combining a COVID-19 Screening Test and Immunity profile with its existing home self-collection kit that allows customers to collect a few drops of blood and send them by mail to CoreMedica Europe’s accredited laboratory in Geneva to screen the anti-SARS-COV-2 IgG antibody and assess any previous infection to SARS-COV-2, the virus responsible for COVID disease, and analyze a set of 5 key biomarkers known to support the immune system (vitamin D, zinc, magnesium, copper, selenium) so as to receive personalized actionable recommendations to help patients build up their natural defenses against the effects of a next potential viral infection. “In this epidemic and containment context the essential objective

Esri and AfroChampions Launch Partnership to Promote GIS in Africa24.9.2020 16:52:00 EESTPress release

Esri, the global leader in location intelligence, today announced a joint initiative with AfroChampions, a Pan-African nonprofit that aims to promote policies that foster private-public collaboration for Africa's economic transformation. The goal of the initiative is to engage leaders in business, governments, the African Union, and other regional economic communities through dialogue and potential partnership building in applying geospatial technology and solutions. This new partnership with AfroChampions seeks to contribute to sustainable economic development in Africa and promote the benefits of a shared geospatial infrastructure throughout the continent. As a majority of Africans still live in rural areas, geographic information system (GIS) technology can create new opportunities for growth, especially in critical fields such as health and telemedicine, land management, agriculture, and mobility. The powerful mapping and data analytics that GIS provides forms a foundation for some

DXC Technology Announces Leadership Appointments to Support the “new DXC"24.9.2020 16:20:00 EESTPress release

DXC Technology (NYSE:DXC) today presented its latest leadership appointments further strengthening the DXC leadership team, the majority being new to DXC within the last year. This team is bringing the “new DXC,” which is focused on its customers and its people, to the market as it executes the company’s transformation journey. DXC Customer Portfolio Leadership Over the past year, CEO Mike Salvino has recruited new IT services industry leaders who bring formidable experience delivering for customers, inspiring people, and running and growing businesses. DXC announces the following appointments and changes to the team that will run DXC’s business and lead execution of the DXC transformation journey: Americas will be led by Jim Brady and David Swift . Jim joined DXC in June 2020 from Accumen, where he was the COO and previously worked at Accenture and Honeywell. David Swift joined DXC in November 2019 from Accolade where he was Chief Service Officer and previously worked at Aon Hewitt an

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom