Vicuron Pharmaceuticals Inc. said data from a Phase III trial of its antifungal product anidulafungin demonstrated superior results compared to fluconazole in invasive candidiasis/candidemia.
The King of Prussia, Pa.-based company said the study, designed to show non-inferiority, ended up demonstrating superiority of anidulafungin vs. fluconazole in the primary endpoint at the end of therapy, with 75.6 percent of the patients treated with anidulafungin recording a response, compared to 60.2 percent of fluconazole-treated patients. Vicuron's product either matched or exceeded results in all secondary endpoints in the 256-patient trial.
"These are very encouraging results," said Dov Goldstein, Vicuron's chief financial officer, adding that the company "was pleasantly surprised" with anidulafungin's statistical superiority to fluconazole in the treatment of hospital-acquired fungal infection.
"The key thing is that this is a disease, which still has a very high mortality rate, about 30 to 40 percent," he told BioWorld Today. "So this is very important information for physicians and patients, as well as our company."
Shares of Vicuron (NASDAQ: MICU) rose $2.20 Monday - 14.2 percent - to close at $17.73.
The double-blind, multicenter, randomized trial compared a 100-mg daily dose of anidulafungin to a 400-mg daily dose of fluconazole in patients with invasive candidiasis/candidemia, infections caused by Candida that tend to affect those with compromised immune systems. Patients during the trial received intravenous infusions of either anidulafungin or fluconazole for 10 to 42 days.
Vicuron reported that 96 of the 127 patients treated with anidulafungin reported a positive response at the conclusion of therapy, while 71 of 118 patients reported responses with fluconazole.
The company said its drug also recorded statistically superior responses in a secondary endpoint. Based on a two-week follow-up visit in the microbiological intent-to-treat population, responses were observed in 64.6 percent (12 of 127) of the patients who received anidulafungin and 49.2 percent (58 of 118) of fluconazole patients. Another secondary endpoint at six weeks after treatment demonstrated non-inferiority, with about 55.9 percent (71 of 127) of patients treated with anidulafungin reporting a response, compared to 44.1 percent (52 of 188) of patients in the fluconazole arm of the study.
Goldstein said Vicuron intends to file a new drug application during the third quarter.
In the meantime, the company will prepare to file next quarter an NDA supplement for anidulafungin in the treatment of esophageal candidiasis. The FDA issued an approvable letter in May, but cited concerns regarding a secondary endpoint associated with relapse rates after two weeks of follow up. (See BioWorld Today, May 25, 2004.)
Anidulafungin, which Vicuron in-licensed from Indianapolis-based Eli Lilly and Co. five years ago, is part of a class of agents known as echinocandins. In prior studies, anidulafungin appeared to show both the potency of polyenes, such as ampotericin B, but with more efficacy against resistant organisms than the azole class, including fluconazole. A common antifungal treatment, fluconazole is the active ingredient in New York-based Pfizer Inc.'s Diflucan.
The FDA is reviewing another Vicuron drug. The company submitted an NDA in December for dalbavancin, a once-weekly antibiotic injection for skin and soft-tissue infections. Goldstein said Vicuron requested priority review for dalbavancin and is waiting to hear from the FDA regarding the review timeline. Dalbavancin is a lipoglycopeptide for infections caused by Gram-positive bacteria, including strains of methicillin-resistant Staphylococcus aureus. If approved, dalbavancin would be marketed against competing agents, such as vancomycin, which must be delivered twice daily.
Vicuron owns worldwide rights to both anidulafungin and dalbavancin. Goldstein said the company expects to market the products in the North America by itself, but "we are discussing our partnering possibilities outside North America."
The company is collaborating on other drug development projects. Goldstein said Vicuron partnered with Novartis AG, of Basel, Switzerland, to develop a deformylase inhibitor, an antibiotic in Phase I. An ongoing collaboration with Pfizer to discover second- and third-generation oxazolidinones is expected to enter Phase I within the next 12 to 18 months.
"We are also moving into late-stage preclinical on another internal project for anaerobic bacteria," Goldstein said. The company should file an investigational new drug application around mid-year.