Matinas BioPharma receives qualified infectious disease product and fast track designations from U.S. FDA for MAT2203 for the treatment of cryptococcal meningitis

Matinas BioPharma

25 July 2019 - Fourth QIDP and fast track designations granted by FDA for MAT2203.

Matinas BioPharma announced today that the U.S. FDA has designated MAT2203, Matinas’ proprietary oral amphotericin B product, as a Qualified Infectious Disease Product (QIDP) with fast track status for the treatment of cryptococcal meningitis. As previously reported, the FDA has designated MAT2203 as a QIDP with fast track status for three other indications, specifically, the prevention of invasive fungal infections due to immunosuppressive therapy, treatment of invasive candidiasis, and treatment of invasive aspergillus.

MAT2203 is Matinas’ orally-administered, encochleated formulation of the broad spectrum fungicidal medication amphotericin B. The Company’s proprietary lipid nano-crystal formulation of amphotericin B has a novel mechanism of absorption and distribution to infected tissues and has the potential to transform the way this potent fungicidal is administered, without the toxicity historically associated with this drug which has limited its use.

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Michael Wonder

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Michael Wonder