FDA grants fast track designation to oral formulation of intravenous antifungal agent

Matinas BioPharma's lead antifungal candidate (MAT2203) earned the FDA's fast track designation as a so-called Qualified Infectious Disease Product, demonstrating the agency's efforts to speed along medications for infectious diseases after years of industry under-investment in that arena. MAT2203 is an oral formulation of the intravenously delivered antifungal agent amphotericin B. The oral formulation will hopefully someday treat invasive candidiasis, a condition that is exhibiting an increasing rate of drug resistance to existing antifungals. "Invasive drug resistant candida fungal infections may spread to critical organs such as the brain, heart or bloodstream and are potentially life-threatening, especially when they occur in immunocompromised patients," said Matinas CEO Roelof Rongen. "While the antifungal amphotericin B has demonstrated little or no resistance in clinical practice, it currently has limited treatment use in fungal infections due to severe toxicity issues. MAT2203 is a novel, encochleated orally bioavailable formulation of amphotericin B and is designed to provide targeted delivery to the site of infection along with a significantly improved safety and tolerability profile." More