Matinas BioPharma Holding Inc., a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective therapeutics for the treatment of serious and life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's lead antibacterial development candidate, MAT2501, as a Qualified Infectious Disease Product (QIDP) for the treatment of non-tuberculous mycobacterium (NTM) infections.
MAT2501 is an orally-administered, encochleated formulation of the broad spectrum aminoglycoside antibiotic agent amikacin which may be used to treat different types of multidrug-resistant bacteria, including NTM and various multidrug-resistant gram negative bacterial infections.
“Treatment of non-tuberculous mycobacterium, or NTM, infections is difficult given resistance to many antibacterial drugs. NTM can lead to chronic infections requiring treatment regimens for a year or longer under current guidelines, and there is growing concern that resistant NTM may be responsible for a disproportionate share of clinical infections,” commented Roelof Rongen, President and Chief Executive Officer of the Company. “The broad spectrum antibiotic, amikacin, has shown very little microbial resistance but its severe side effects and intravenous delivery make it impractical and unsafe for the long-term therapy required to resolve these very serious and often life-threatening infections.”
MAT2501 is being developed with Matinas’ proprietary, lipid-crystal, nanoparticle delivery technology that aims to provide a safer, more tolerable and convenient formulation of this powerful antibiotic. “Preclinical data shows MAT2501 has the oral bioavailability and targeted delivery directly to the site of infection and the potential to change the treatment paradigm for both NTM lung and disseminated infections,” added Mr. Rongen.
Matinas BioPharma is preparing to file an Investigational New Drug (IND) application for MAT2501 with the FDA imminently. QIDP designation, provided under the Generating Antibiotic Incentives Now Act (GAIN Act), offers certain incentives for the development of new antibacterial or antifungal drugs, including eligibility for Fast Track, priority review and, if MAT2501 is ultimately approved by the FDA, eligibility for an additional five years of marketing exclusivity.
This marks the second QIDP designation for a Matinas drug candidate. In August 2015, MAT2203, which is entering a Phase 2a clinical trial with the NIH’s National Institute for Allergy and Infectious Diseases, received QIDP and Fast Track designations for the treatment of invasive candidiasis. MAT2203 is an orally-administered, encochleated formulation of the broad spectrum fungicidal medication amphotericin B, a powerful, intravenously-administered antifungal agent.
“These government incentives such as QIDP and Fast Track underscore the lack of safe and effective antibacterial and anti-fungal medicines, and we are committed to leveraging our cochleate, lipid-crystal, nanoparticle delivery technology to bring much needed therapies to patients and physicians,” said Jerome D. Jabbour, Co-Founder, Executive Vice President and Chief Business Officer of Matinas.
