The FDA granted orphan drug designation to Matinas BioPharma’s broad-spectrum fungicidal product MAT2203 for the treatment of cryptococcosis, a potentially fatal fungal infection.
MAT2203 is an orally-administered formulation of amphotericin B, which is currently in phase 2 clinical development. The oral treatment uses nano-crystals to deliver the fungicide to infected tissue and avoids the toxicity seen with intravenously administered amphotericin B.
MAT2203 previously received Qualified Infectious Disease Product (QIDP) and fast track status for three indications — prevention of invasive fungal infections due to immunosuppressive therapy, treatment of invasive candidiasis, and invasive aspergillus.
The novel delivery mechanism could make MAT2203 a valuable treatment for invasive fungal infections like cryptococcal meningitis, the company says.