Enrollment in Inhibitex’ ongoing phase III clinical trial of Veronate for the prevention of hospital-associated infections in very low birth weight infants has outpaced the company’s initial expectations and it has now enrolled more than one-third of the 2,000 patients it intends to enroll in the trial.
Additionally, the company reported that an independent data safety monitoring board has met to review safety and other data available from the first 500 patients enrolled in the trial and unanimously recommended that the trial proceed as designed without modification.
Inhibitex also announced that it has completed enrollment in its 60-patient phase II clinical trial of Aurexis in patients with documented Staphylococcus aureus (S. aureus) bloodstream infections.
“We made significant progress over the past six months and ended 2004 well-positioned to achieve our clinical development objectives for both Veronate and Aurexis. We intend to continue to build on this momentum and further drive these programs forward this year,” stated Dr William Johnston, president and CEO of Inhibitex.
Based upon this enrollment rate, the company is confident that it will be able to complete Veronate trial enrollment in Q4 2005.
Veronate is a novel, antibody-based investigational drug being developed to prevent staphylococcal infections in premature, very low birth weight infants that weigh less than 1,250g at birth. Due to the intensive care they receive, their underdeveloped immune system and their lengthy stay in the neonatal intensive care unit, these infants are highly susceptible to staphylococcal and other hospital-associated infections.
In a phase II clinical trial completed early last year, those patients that received Veronate at 750mg/kg experienced 63% and 67% fewer S. aureus and Candida infections, respectively, and 36% fewer deaths than those that received placebo.