16 January 2018 - - SAB-301, Sioux Falls, South Dakota-based antibody therapeutics specialist SAB Biotherapeutics, Inc.'s immunotherapy against Middle East respiratory syndrome (MERS), a newly discovered, contagious and sometimes fatal respiratory illness, caused by a virus known as MERS coronavirus (MERS-CoV), appears safe in a Phase I clinical trial, the company said.
Results of the study, sponsored, funded and conducted by National Institutes of Health (NIH), have been published in The Lancet Infectious Diseases.
Presently, there are no approved vaccines or treatments for MERS.
Since the first confirmed case in Saudi Arabia in 2012, the illness has spread to 27 countries and more than 2,000 people, with a fatality rate approaching 40%, according to the World Health Organization.
In the study, 28 volunteers were treated with SAB-301 and 10 with a placebo. Six groups of volunteers received different intravenous doses and were assessed six times over 90 days.
Complaints were common among the treatment and placebo group including mild headache and cold symptoms.
Funding for the Phase I clinical manufacturing was provided by a USD 5.3m contract from Biomedical Advanced Research and Development Authority (BARDA), including an allotment for Phase II trials planned to evaluate the potency and dosing in patients suffering with MERS in endemic countries.
SAB Biotherapeutics is a clinical stage biopharmaceutical company. Utilizing advanced polyclonal antibody science, the company is delivering a large-scale platform to create fully human immunoglobulins.
This natural production platform holds the potential for treatment of public health problems, rare conditions, long-term diseases and global pandemic threats.
NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the US Department of Health and Human Services.
It is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.