Not a month removed from its initial public offering, Inhibitex Inc. advanced its lead product into a pivotal study.
The Alpharetta, Ga.-based company began a Phase III trial of Veronate, an antibody-based investigational drug being developed to prevent hospital-associated infections in very-low-birth-weight infants. To date, 14 sites have been included and about 70 other neonatology intensive-care units remain in various stages of the initiation process.
The study began enrolling patients shortly after the anti-infective company priced its $35 million IPO early last month, but Inhibitex held off on announcing the news due to SEC-imposed quiet-period rules. The trial stems from Phase II findings that showed Veronate to be safe and well tolerated in a 512-patient trial completed late last year. The timing for the IPO and the drug's forward progress hardly was accidental, said Inhibitex President and CEO William Johnston.
"That meant that we're going to have a portfolio with one product in Phase III development and another in Phase II," he told BioWorld Today. "And our assessment, based on communications with the investment community, was that this is the profile of a company that is financeable' in a public offering."
Following Phase II results, dialogue with the FDA led to an agreement on trial design for Veronate, which has fast-track and orphan drug status.
The study is designed to enroll 2,000 patients over about 18 months, said Russell Plumb, Inhibitex's chief financial officer. The trial's primary endpoint is demonstration of efficacy in preventing hospital-associated infections due to Staphylococcus aureus in infants that weigh between 500 grams and 1,250 grams at birth. Secondary endpoints include a reduction in the frequency of hospital-associated infections due to Candida species (fungus) and Coagulase-negative staphylococci, and a reduction in the mortality rate among the high-risk infants.
Each patient will be followed for 70 days, Plumb said, meaning the North America-based study could close around the end of next year. Half the patients will be randomized into a treatment arm, with the rest getting placebo.
Inhibitex's protocol is designed to show that Veronate can be used to prevent hospital-associated infections in the nearly 43,000 low-birth-weight infants born each year in the U.S.
"At the present time, there is no product out there that is approved or recommended for use in a preventive manner in these very-low-birth-weight infants," Johnston said, noting that antibiotics are used to treat hospital-associated infections after diagnosis. "Up to half of those infants will acquire a hospital-associated infection."
He added that a study reported by the National Institutes of Health in Bethesda, Md., showed that such infections extend low-birth-weight infants' stays in neonatal intensive-care units by an average of 19 days. By preventing infections from staphylococcal and Candida organisms, Veronate could cut down on hospital stays.
"These are very serious, life-threatening infections," Johnston said, "and we think that based on the Phase II data, Veronate hits right at these two critical infections."
Inhibitex owns all rights to the product, and plans to build its own sales force for eventual U.S. sales t, what Johnston labeled, a concentrated market. Outside the U.S., the company plans to seek a commercialization partner.
Veronate is the most advanced product candidate at Inhibitex, which has five drug development programs in total. All are based on its MSCRAMM protein platform technology.
Its other clinical-stage product is Aurexis, a humanized monoclonal antibody that is in a 60-patient Phase II trial in combination with antibiotics for treating serious S. aureus bloodstream infections. The company also has all rights to that product, as well.
Inhibitex's three preclinical programs include a partnership with Wyeth, of Madison, N.J., to develop staphylococcal vaccines.
On Wednesday, Inhibitex's stock (NASDAQ:INHX) lost 3 cents to close at $7.21.