ATLANTA -- Inhibitex, Inc., a biopharmaceutical company focused on the prevention and treatment of staphylococcal and other bacterial infections, today announced the start of a Phase I clinical trial of its lead product, Veronate, for the prevention of staph infections in premature infants. Inhibitex is developing Veronate(TM) to reduce the risk of both Staphylococcus aureus (S. aureus) and coagulase-negative staphylococcal infections in very low birth weight infants.
A recent study conducted by the National Institute of Child Health and the Human Development Neonatal Research Network indicates that S. aureus and coagulase-negative staphylococci account for more than 55 percent of infections in very low birth weight infants. Approximately 60,000 very low birth weight infants (i.e. infants weighing less than 1,500 grams, or approximately 3 pounds) are born each year in the United States, according to data published by the Centers for Disease Control (CDC) and the U.S. Census Bureau. Very low birth weight infants are at increased risk of staph infections because their immune systems are under-developed; they have long hospital stays and require multiple medical procedures. Many of these infants acquire staph infections while receiving care in the neonatal intensive care unit.
"Hospital-acquired infections are a major challenge to the health of our smallest patients," stated Dr. Carol Baker, professor of pediatrics, molecular virology and immunology head, Section of Infectious Diseases, Department of Pediatrics of the Baylor College of Medicine. "New strategies to manage this ever-challenging problem are desperately needed to give them the best chance of survival."
The open label, Phase I study will evaluate the safety and tolerability of two different doses of Veronate in 36 hospitalized, very low birth weight infants. In addition to assessing the safety of Veronate(TM), blood levels of active antibodies will be measured in all participating infants.
"We are very pleased that the FDA has given us the 'go-ahead' for our initial study of Veronate for this unmet medical need. Prevention of these staph infections could result in the overall lower use of antibiotics in premature infants and the reduction of antibiotic resistance by hospital- acquired infections," stated Seth Hetherington, MD, chief medical officer for Inhibitex. "We expect to complete the study in the fourth quarter of this year, after which we plan to initiate a double-blinded, placebo-controlled Phase II study of up to 500 infants. This study will identify the optimum dose for a pivotal Phase III trial and assess the potential of Veronate to prevent infections."
Veronate is a novel antibody-based product that belongs to a class of drugs referred to as immune globulins. Immune globulins are widely used to treat immunocompromised patients and to prevent a number of disease states, including hepatitis B, respiratory syncytial virus (RSV), cytomegalovirus (CMV), rabies, tetanus and Rh incompatibility in newborns. Veronate(TM) has been uniquely designed and formulated for pediatric use. In vivo studies indicate that the prophylactic use of Veronate can dramatically reduce the incidence and severity of both methicillin resistant S. aureus and S. epidermidis infections. Inhibitex is independently developing Veronate(TM) for commercialization in the United States, and is evaluating commercialization strategies for the rest of the world.
Inhibitex, Inc., headquartered in Atlanta, is a biopharmaceutical company developing and commercializing "first in field" antibody-based products for the treatment and prevention of staphylococcal and other bacterial and fungal infections. The company is using its proprietary MSCRAMM protein technology platform to develop a pipeline of products. This technology utilizes specific antibodies that inhibit the biological activity of a family of surface proteins present on certain pathogenic organisms. The company currently has several products in clinical and preclinical development. In addition, the company is collaborating with Wyeth on the development of a nosocomial staphylococcal vaccine.