ATLANTA -- Inhibitex, Inc., a biopharmaceutical company focused on the prevention and treatment of bacterial and fungal infections, announced today that it has received FDA clearance to initiate a Phase I clinical trial to assess the safety and tolerability of its second product candidate, Aurexis, a humanized monoclonal antibody.
Aurexis is being developed for the prevention and treatment of life-threatening S.
aureus infections. The company's lead product candidate, Veronate, is currently in a Phase II clinical trial and is being developed to prevent both Staphylococcus epidermidis (S. epidermidis) and S. aureus infections in very low birth-weight infants.
S. aureus is a serious and potentially deadly pathogen that causes a growing number of community- and hospital-acquired infections every year. In 2002, approximately one million people worldwide, and 300,000 in the United States alone, acquired S. aureus infections from a hospital visit. More than half of these infections were caused by antibiotic-resistant strains, which are a significant contributor to the approximately 50,000 deaths associated with S. aureus infections each year in the U.S.
"Over the past decade, the medical community has seen a dramatic increase
in antibiotic-resistant bacteria," said Seth Hetherington, MD, chief medical officer for Inhibitex. "This trial is a crucial first step in evaluating the potential of a novel agent that we believe can contribute to a much-needed solution for a critical unmet clinical need."
The Phase I study will evaluate the safety and tolerability of four different doses of Aurexis administered intravenously to 16 healthy volunteers. In addition to assessing its safety, the trial will monitor blood levels of Aurexis in all volunteers. Patient dosing is scheduled to begin within weeks, with enrollment expected to be completed in early July.
The company anticipates following up this trial with a Phase II program to further test the safety of Aurexis and explore its effect, in combination with antibiotics, to treat hospital-acquired and other difficult to treat S. aureus infections.
Aurexis is a humanized monoclonal antibody that specifically recognizes an MSCRAMM protein found on virtually all strains of S. aureus. Preclinical models have demonstrated that when used prophylactically as monotherapy, or therapeutically in combination with antibiotics, Aurexis can significantly reduce the incidence and severity of infection and the mortality associated with systemic S. aureus infections, including infections caused by antibiotic-resistant S. aureus.