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SF001, a next-generation amphotericin B analog polyene antifungal, has completed a first‑in‑human single‑ascending dose Phase 1 trial and is in a multiple‑ascending dose Phase 1 study; it has FDA Fast Track and QIDP designations for early therapy of presumed invasive fungal disease and treatment of invasive aspergillosis, with preclinical data showing potent antifungal activity and reduced renal toxicity vs amphotericin B.
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