Matinas BioPharma Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead drug candidate, MAT2203, as a Qualified Infectious Disease Product (QIDP) with Fast Track status for prophylactic treatment of invasive fungal infections due to immunosuppressive therapy.
MAT2203 is Matinas BioPharma’s orally-administered, encochleated formulation of the broad spectrum fungicidal medication amphotericin B. The Company’s proprietary lipid-crystal nano-particle formulation of amphotericin B has a novel mechanism of absorption and distribution to infected tissues and has the potential to transform the way this potent fungicidal is administered. As previously reported, the U.S. FDA has designated MAT2203 as a QIDP with Fast Track status for the treatment of invasive candidiasis and aspergillus.
“Prophylaxis represents an enormous unmet need in the space due to the lack of preventative treatments and incompatibility of currently available antifungals because of their drug-drug interaction, lack of efficacy, probable side-effects risk and toxicity. Patients who receive chemotherapy for the treatment of certain cancers or are on immunosuppressive therapy to facilitate bone marrow/organ transplants or to treat an autoimmune disease are at high risk for contracting invasive fungal infections. Matinas BioPharma’s orally-available, broad spectrum fungicidal agent, MAT2203, has demonstrated excellent tolerability in previous studies and has the potential to become the prophylaxis drug of choice for these immunocompromised individuals,” stated Roelof Rongen, Chief Executive Officer of Matinas Biopharma.
“We believe this is the first QIDP issued for an orally available, antifungal for the preventative treatment of fungal infections, which represents a tremendous opportunity for the Company. We look forward to continuing the development of MAT2203 and adding additional evidence for the broad spectrum benefit and potential to effectively prevent serious and potentially life-threatening fungal infections with our formulation of amphotericin B utilizing our proprietary lipid-crystal cochleate delivery technology,” added Mr. Rongen.
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 MAT2203 is ultimately approved by the FDA, eligibility for an additional five years of marketing exclusivity. The award of Fast Track status enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.
Jerome D. Jabbour, Co-Founder and President, commented, “We continue to amass a growing body of compelling data with MAT2203, and we believe this QIDP designation represents a culmination of all of the work we have done so far to demonstrate its potential to bring a much needed preventative, broad-spectrum and significantly less toxic antifungal to patients at increased risk to contract invasive and resistant fungal infections. With important patient data on efficacy and safety from our ongoing Phase 2a trial with MAT2203 expected in the near term, these QIDP and Fast Track designations for MAT2203 in prophylaxis position us extremely well for the balance of our planned development program as we look to utilize the disruptive benefits of our technology platform to fill significant unmet medical need.”
