Matinas BioPharma Announces Positive Opinion by the European Medicines Agency on Orphan Drug Designation for MAT2203 for the Treatment of Cryptococcosis
July 25 2022 - 06:30AM
GlobeNewswire Inc.
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Matinas BioPharma (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of nucleic acids and small molecules with its lipid nanocrystal (LNC) platform technology, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending MAT2203 for designation as an orphan medicinal product for the treatment of cryptococcosis. The U.S. Food and Drug Administration (FDA) previously granted Orphan, Qualified Infectious Disease Product (QIDP) and Fast Track Designations to MAT2203 for the treatment of cryptococcosis. Matinas is currently preparing to evaluate MAT2203 in a pivotal Phase 3 trial in patients with cryptococcal meningitis.
“The positive opinion for Orphan Drug Designation from the EMA is another important milestone for MAT2203 and reflects our commitment to position MAT2203 for global development and approval,” said Theresa Matkovits, Ph.D., Chief Development Officer of Matinas BioPharma. “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, with a prevalence in the EU of not more than five in 10,000 people, and with either no currently approved method of diagnosis, prevention, or treatment or with significant benefit to those affected by the 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: the treatment of invasive candidiasis, and treatment of invasive aspergillosis, and the prevention of invasive fungal infections due to immunosuppressive therapy.
About MAT2203
MAT2203 is Matinas’ orally administered formulation of the broad-spectrum fungicidal medication amphotericin B, which is currently completing Phase 2 clinical development. This oral formulation utilizes the Company’s proprietary 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 oral delivery has the potential to make MAT2203 an important and invaluable treatment for invasive fungal infections like cryptococcal meningitis, mucormycosis, and invasive aspergillosis.
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