The FDA granted fast track and qualified infectious disease product (QIDP) designations to Matinas BioPharma’s (NYSE AMER:MTNB) MAT2203 for the treatment of cryptococcal meningitis.
MAT2203 is a lipid nano-crystal formulation of amphotericin B, a potent fungicide. The drug candidate has a novel mechanism of absorption and distribution that offers administration options, as well as a lower toxicity profile.
“Cryptococcal meningitis is a life-threatening condition most commonly observed in immunocompromised individuals,” Jerome Jabbour, Matinas’ CEO, said in a statement.
“These QIDP and fast track designations for MAT2203 are another major step forward for this program, positioning Matinas for eligibility for an additional five years of marketing exclusivity in cryptococcal meningitis if MAT2203 is approved by the FDA,” he added.
Matinas is planning its first clinical study of MAT2203 for the treatment of cryptococcal meningitis, which is fully funded by the National Institutes of Health.
The FDA previously granted MAT2203 as a QIDP with fast track status for the treatment of invasive candidiasis and aspergillus; and the prevention of invasive fungal infections due to immunosuppressive therapy.