The US Food and Drug Administration granted the company orphan drug designation for its MAT2203 treatment for cryptococcosis.
Matinas BioPharma Holdings (NYSE American:MTNB) has announced it has received orphan drug designation from the US Food and Drug administration for MAT2203, a treatment for cryptococcosis.
As quoted in the press release:
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.
“Orphan drug designation is yet another major step forward for MAT2203 in the treatment of life-threatening fungal infections, and adds to the prior Qualified Infectious Disease Product (QIDP) and Fast Track designations this product has already received,” commented Theresa Matkovits, Ph.D., Chief Development Officer of Matinas. “We believe MAT2203 represents a promising new approach for the treatment of severe fungal infections and addresses one of the most important limitations of current antifungal treatment options. Adding orphan drug designation to the QIDP for the treatment of cryptococcal meningitis potentially positions MAT2203 for up to 12 years of marketing exclusivity, if approved.”
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.