A publicly traded Swedish biotech will soon launch a short-term clinical trial evaluating the efficacy and safety of anakinra and emapalumab to treat hyper-inflammatory syndrome—one of the most dangerous complications associated with severe COVID-19. Swedish Orphan Biovitrum AB (Sobi) (STO: SOBI) has responded to a request by Italian Doctors to undertake this study by the National Institute for Infectious Diseases, an organization coordinating research activities for the SARS-CoV-2 epidemic in Italy. The Nordic sponsor plans on publishing the protocol on ClinicalTrials.gov.
Identified Need in Italy for Severe COVID-19 Cases
Based on the generation of emerging data points and ongoing observations by physicians on the ground treating COVID-19 patients, the Stockholm-headquartered company’s rare disease focused products will be used in a targeted clinical study.
Anakinara (Kineret®) is a recombinant protein drug approved for the treatment of patients with CAPS (Cryopyrin Associated Periodic Syndrome), RA (Rheumatoid Arthritis) and Still’s disease. This approved drug therapy harnesses the biological activity of IL-1 by binding to the interleukin-1 type 1 receptor, expressed in a wide variety of tissues and organs. Their other drug emapalumab (Gamifant®) is a monoclonal antibody (mAB) that binds to and neutralizes interferon gamma (IFNy). Gamifant is approved in the United States for pediatric (newborn and older) and adult primary hemophagocytic lymphohistiocytosis (HLH) patients with refractory, recurrent or progressive disease, or intolerance to standard-of-care HLH therapy.
A Calling to Support Others
Sobi’s CEO Guido Oelkers acknowledges the importance of contribution and the bigger picture involved with a global crisis, such as the COVID-19 pandemic, noting, “The COVID-19 global pandemic requires everyone to play their part. We believe it is our duty to support this important request and will focus our attention on this exploratory study.”
Who is Sobi™
A specialized international biopharmaceutical company, Sobi seeks to transform the lives of people with rare disease. With headquarters in Sweden, they offer sustainable access to innovative therapies in the areas of hematology, immunology, and specialty indications. The company employs 1,400 across Europe, North America, the Middle East, Russia, and North Africa. With revenues of approximately $1.4 billion, they are listed on Nasdaq Stockholm.
An expert in the process development and manufacturing of recombinant protein drugs since the technology’s first developments three decades ago, the company was part of KabiVitrum. It was actually formed in 2001 through the merger of several units of Pharmacia (Pfizer) and spun off to a consortium of investors led by Nordic Capital and MPM Capital Funds. Back in 2002, it sold off its plasma operation to Octapharma to concentrate its focus and emphasis on protein-based and small molecular drugs.