Matinas biopharma receives orphan drug designation from u.s. fda for mat2203 for the treatment of cryptococcosis

Matinas biopharma holdings, inc. announced that the u.s. food and drug administration (fda) has granted orphan drug designation to mat2203, matinas’ proprietary oral amphotericin b product, for the treatment of cryptococcosis, a life-threatening fungal infection most commonly observed in immunocompromised individuals. mat2203 is matinas’ orally-administered formulation of the broad-spectrum fungicidal medication amphotericin b, which is currently in phase 2 clinical development. this oral formulation utilizes the company’s proprietary lipid nano-crystal (lnc) technology to deliver amphotericin b in a way that targets infected tissues and avoids the toxicity normally seen with intravenously administered amphotericin b. this novel mechanism of delivery has the potential to make mat2203 an important and valuable treatment for invasive fungal infections like cryptococcal meningitis, which is within the scope of this fda-granted orphan drug designation. the fda grants orphan drug designation to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the u.s. the designation allows the drug developer to be eligible for a seven-year period of u.s. marketing exclusivity upon approval of the drug, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical trial design assistance, and the waiver of prescription drug user fee act (pdufa) filing fees. the fda has previously designated mat2203 as a qidp with fast track status for three additional indications, specifically, the prevention of invasive fungal infections due to immunosuppressive therapy, the treatment of invasive candidiasis and invasive aspergillus.
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