In the small safety and immunogenicity study, there was a 36% reduction in median time from administration of the drug to hospital discharge in the Altastaph-treated patients, as compared to the placebo-treated patients (nine days in the Altastaph group versus 14 days in the placebo group).
This substantial reduction in the length of hospital stay for the Altastaph-treated group indicates that Staphylococcus aureus (S. aureus) antibodies provided by Altastaph could be associated with considerable medical benefit in the treatment of persistent S. aureus infections.
Altastaph is produced by immunizing healthy volunteers with StaphVAX, Nabi Biopharmaceuticals’ vaccine in development for providing protection in at-risk patients against S. aureus infections. S. aureus bacteria are the most common cause of hospital-acquired infections and are becoming increasingly resistant to antibiotics, which may result in illness and/or death.
The results of the study also demonstrated that Altastaph was well tolerated and no drug-related, serious adverse events were reported.
“Based on these results, we intend to advance our current Altastaph formulation, to further assess its role in treating S. aureus infections,” commented Dr Henrik Rasmussen, senior vice president of clinical research, medical and regulatory affairs, and project management at Nabi Biopharmaceuticals.
“We plan to meet with both US and European regulatory authorities to share the data from this trial and work with them to define the next clinical steps for Altastaph,” he said.