Background: ANID is a novel echinocandin with potent in vitro and in vivo activity against Candida, including azole and Ampho B-resistant organisms. ANID's distinct PK characteristics and favorable safety profile support its development as a firstline therapeutic agent in mucosal and invasive fungal infections. Methods: A global Phase 3 randomized, multicenter, double blind study compared IV ANID (50 mg/day, 100 mg day 1) or oral FLU (100 mg/day, 200 mg day 1) for 14-21 days in pts with endoscopically and microbiologically confirmed EC. Successful endoscopic response (ER) at EOT was defined as Grade 0 or improvement of one grade. Successful clinical response (CR) was cure (absence of symptoms, no additional systemic antifungal therapy (AFT) or improvement (less severe symptoms compared to baseline, no AFT). Safety labs, ECGs and AEs were collected. The HIV negative subgroup was evaluated Results: 37 HIV seronegative pts (Anid N=19; Flu N=18) with EC were clinically evaluable at EOT. Mean age (range) in the ANID and FLU groups were 43 (23-65) and 38 (18-61) years, respectively. Approximately 50% of the population was male. A higher proportion of white (44% vs 26%) pts were in the FLU group and a higher proportion of black (37% vs 22%) pts were in the ANID group. The majority of patients had moderate to severe symptoms and disease. At EOT, all 19 ANID and 18 FLU pts were endoscopic successes. The majority of pts were cured: 94.7% (ANID); 88.9% (FLU). In the overall population (N=601), ANID and FLU were well-tolerated. Few pts had drug-related AEs (9.3% ANID, 12.0% FLU). Most common related AEs in both groups included phlebitis, nausea, headache and thrombocytopenia. Conclusions: ANID was efficacious at 50 mg/day in HIV negative pts with EC.
Full conference title:
15th Annual Focus on Fungal Infections
- FFI 15th (2005)