1413. A Phase IIa Efficacy Safety Tolerability and Pharmacokinetic (PK) Study of Encochleated Amphotericin B in Patients with Mucocutaneous (Esophogeal Oropharyngeal Vulvovaginal) Candidiasis Who are Refractory or Intolerant to Standard Non-Intravenous Therapies

摘要

BackgroundCurrent oral therapeutic options for chronic mucocutaneous candidiasis (CMC) are often associated with resistance and toxicity. Amphotericin B (AMB) has broad fungicidal activity and markedly resists emergence of resistance but requires parenteral administration and monitoring for significant nephrotoxicity, which worsens with chronic treatment. Encochleated amphotericin B (CAMB) is a novel oral formulation of AMB. In animal models, CAMB demonstrates antifungal activity with similar efficacy as intraperitoneal AMB deoxycholate, but without the associated toxicity. This on-going patient volunteer study assesses the efficacy, safety, tolerability and PK of CAMB in patients with CMC who are refractory or intolerant to standard oral azole antifungals.