Matinas: MAT2203 Gets EMA Positive Opinion On Orphan Drug Designation To Treat Cryptococcosis

(RTTNews) - Matinas BioPharma Holdings, Inc. (MTNB), a clinical-stage biopharmaceutical company, announced Monday that the European Medicines Agency or EMA Committee for Orphan Medicinal Products or COMP has adopted a positive opinion recommending MAT2203 for designation as an orphan medicinal product for the treatment of cryptococcosis.

In pre-market activitry, Matinas BioPharma shares were gaining around 5 percent to trade at $0.90.

MAT2203 has already received U.S. Food and Drug Administration's Orphan, Qualified Infectious Disease Product or QIDP and Fast Track Designations for the treatment of cryptococcosis.

MAT2203 is Matinas' orally administered formulation of the broad-spectrum fungicidal medication amphotericin B, which is currently completing Phase 2 clinical development.

Matinas said it is currently preparing to evaluate MAT2203 in a pivotal Phase 3 trial in patients with cryptococcal meningitis.

Theresa Matkovits, Chief Development Officer of Matinas BioPharma, said, "We believe that MAT2203 has the potential to transform the treatment of cryptococcosis, as well as other deadly invasive fungal infections. This designation reflects the significant need for new therapies to treat fungal disease and we look forward to working with the EMA and FDA to potentially deliver MAT2203 to patients."

The orphan medicinal product designation by the European Commission is granted to medicines that treat, prevent, or diagnose a life-threatening or chronically debilitating rare disease. The designation potentially provides certain benefits to Matinas, including 10-year EU market exclusivity upon regulatory approval, if received, reductions in EMA application fees, and access to protocol assistance.

The FDA has previously designated MAT2203 as a QIDP with Fast Track Status and Orphan Drug Disease designation for three additional indications. These include the treatment of invasive candidiasis, and treatment of invasive aspergillosis, and the prevention of invasive fungal infections due to immunosuppressive therapy.

For More Such Health News, visit rttnews.com