Washington Editor

Vicuron Pharmaceuticals Inc. started a Phase III trial to compare its antibiotic candidate, dalbavancin, with vancomycin, a standard of care for the treatment of skin and soft-tissue infections.

The 150-patient Phase III is designed to evaluate the clinical efficacy of dalbavancin compared to vancomycin for the treatment of adult patients with skin and soft-tissue infections (SSTIs) suspected or confirmed to be caused by methicillin-resistant Staphylococcus aureus (MRSA).

It's not the first Phase III for dalbavancin. Vicuron, of King of Prussia, Pa., plans to include the new Phase III trial as part of a new drug application based on two larger pivotal Phase III trials currently in progress. All three are expected to be completed by mid-2004, with data ready sometime during the third quarter of 2004, Dov Goldstein, Vicuron's chief financial officer, told BioWorld Today. Vicuron anticipates filing the NDA during the second half of 2004.

Dalbavancin, a semi-synthetic glycopeptide antibiotic, is a once-weekly, injectable, hospital-based treatment that belongs to the same class as vancomycin, one of the few products available to treat MRSA and MRSE (methicillin-resistant Staphylococcus epidermidis).

Company officials believe dalbavancin boasts marketing advantages because of its once-weekly dosing.

"This dosing regimen allows for cost-effective administration and a reduced need for intravenous lines that can prolong the risk of local and bloodstream infection, which may translate into shorter hospital stays for some patients," George Horner, Vicuron's president and CEO, said in a prepared statement.

The Phase III comparative study announced Wednesday is a randomized, controlled, multicenter, open-label trial. Patients will receive either two doses of intravenous dalbavancin - the first dose on day one followed by a second dose on day eight - or twice daily doses of intravenous vancomycin for 14 days. The primary endpoint will be the assessment of clinical response at the time of a follow-up visit.

Meanwhile, Vicuron continues enrolling the pivotal studies. While Goldstein wouldn't discuss specifics surrounding the number of patients enrolled, he did say the trials were on schedule.

Initiated in December by Versicor Inc. before it merged with Biosearch Italia SpA and Vicuron was born, the pivotal Phase III studies are randomized, double-blind trials. Each is designed to evaluate about 550 hospitalized patients receiving dalbavancin vs. standard antibiotics. (See BioWorld Today, Dec. 18, 2002, and Aug. 1, 2002.)

In the first trial, patients with complicated SSTIs will receive either a 1-gram dose of dalbavancin on the first day followed by a 500-mg dose on the eighth day, or doses of linezolid for 14 days. In the second trial, patients with uncomplicated SSTIs will receive either a 1-gram dose of dalbavancin the first day with the option of a 500-mg dose on the eighth day or intravenous cefazolin, followed by oral cephalexin. On day eight, the investigator will decide the duration of the study therapy (seven or 14 days) based on the patient's status.

Dalbavancin actually was discovered by Biosearch Italia, of Milan, Italy, although Versicor, of Fremont, Calif., had in-licensed North American rights. Through the $225 million stock swap that merged the companies, all the rights now reside with Vicuron.

Goldstein said Vicuron plans to sell dalbavancin on its own in North America and Europe, but expects to out-license the product in Japan.

Beyond dalbavancin, Vicuron expects to launch (also on its own) its lead product candidate, anidulafungin, in the first half of 2004. The FDA currently is reviewing the NDA for anidulafungin, an antifungal agent for the treatment of esophageal candidiasis, an infection of the esophagus that commonly affects patients with compromised immune systems. (See BioWorld Today, April 29, 2003.)

Vicuron's stock (NASDAQ:MICU) closed Wednesday at $18.59, down 4 cents.