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ATLANTA - Inhibitex, Inc., a biopharmaceutical company focused on the prevention and treatment of staphylococcal and other bacterial infections, today announced that Veronate, its lead product, has been granted fast track status by the Food and Drug Administration (FDA) for the prevention of nosocomial infections, caused by staphylococci, in very low birth weight infants (less than three pounds).
"This FDA designation supports our conviction that Veronate has the potential to address a serious unmet medical need in neonatal intensive care," remarked David M. Wonnacott, Ph.D., vice president of regulatory affairs, Inhibitex. He added, "Fast track status gives Veronate a high priority at the FDA, and provides us with the opportunity to work more closely with the agency during our clinical development process. We may now potentially submit portions of the biological license application (BLA) for Veronate for early review and anticipate making a request for an accelerated approval when this license application is complete."
The company also announced that it has completed patient enrollment in its open label, Phase I clinical study of Veronate in 36 very low birth weight infants. The purpose of the Phase I study was to evaluate the safety, tolerance and pharmacokinetics (absorption, distribution, metabolism and excretion) of Veronate. The company anticipates initiating a double-blinded, placebo-controlled Phase II study for Veronate in early 2003.
Veronate is a novel antibody-based product that 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 susceptible and resistant S. aureus and S. epidermidis infections. In addition to being designated a Fast Track product, Veronate has also been granted Orphan Drug status by the FDA. Inhibitex is independently developing Veronate 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 serious bacterial and fungal infections. The company is utilizing its proprietary MSCRAMM protein technology platform to develop a pipeline of these products. This technology utilizes specific antibodies that inhibit the biological activity of a family of surface proteins present on certain pathogenic organisms. In addition to Veronate, the company currently has several other programs in various stages of pre-clinical development and is collaborating with Wyeth on the development of a nosocomial staphylococcal vaccine.