Matinas BioPharma Successfully Treats Limb-Threatening Mucor Infection with MAT2203

Matinas BioPharma Holdings, Inc., a clinical-stage biopharmaceutical company based in Bedminster, N.J., announced a remarkable success with its novel treatment for a severe fungal infection. The company developed MAT2203, an oral formulation of the potent antifungal amphotericin B, which was used to treat a 22-year-old male patient suffering from polymicrobial necrotizing fasciitis. This condition, often referred to as flesh-eating disease, included a drug-resistant strain of Lichtheimia, a fungus known for its aggressive invasion of blood vessels.

The patient was treated at New York Presbyterian/Weill Cornell Medical Center under the guidance of Dr. Sharan Yadav, an Infectious Disease Fellow, through Matinas’ Compassionate/Expanded Use Access Program. Initially, the patient was given AmBisome®, an intravenous form of amphotericin B, which showed initial efficacy but led to severe side effects, including significant renal toxicity that necessitated intensive care. The switch to oral MAT2203 not only managed the infection effectively but also allowed the patient's kidney function to return to normal. After six weeks of treatment, the patient was discharged and could walk with assistance.

Dr. Yadav expressed satisfaction with the treatment outcomes, noting the patient's significant improvement, transition out of the ICU, and return home to continue rehabilitation. This case highlights the potential benefits of MAT2203 over traditional intravenous treatments, particularly in terms of reducing renal toxicity and improving patient quality of life.

The Compassionate/Expanded Use Access Program has so far included 24 patients treated with MAT2203, with an additional four cases pending submission and FDA approval. These patients had either not responded to azole therapy, encountered drug interactions with azole therapy, or could not tolerate the intravenous form of amphotericin B due to toxicity. Remarkably, in all cases where patients experienced renal toxicity from IV-amphotericin B, the switch to MAT2203 reversed the toxicity and restored renal function to baseline.

Theresa Matkovits, PhD, Chief Development Officer at Matinas, expressed enthusiasm over the consistent positive impacts of oral MAT2203. The Compassionate/Expanded Use Access Program has garnered significant interest from infectious disease specialists nationwide, and the upcoming ORALTO Phase 3 registration trial aims to further validate these results. This trial will evaluate MAT2203 as an early step-down therapy for invasive aspergillosis, positioning it for a New Drug Application (NDA) filing. The company is also actively pursuing partnerships to advance MAT2203 into Phase 3 development.

MAT2203 is still under development and has not yet received global approval. Matinas BioPharma aims to address the significant limitations of current amphotericin B products, such as renal toxicity and anemia, by offering a targeted oral delivery system. This new approach could potentially revolutionize the treatment of invasive fungal infections, combining the efficacy of amphotericin B with reduced toxicity.

Additionally, MAT2203 has shown promise in the completed Phase 2 EnACT study, which evaluated its efficacy in HIV patients suffering from cryptococcal meningitis. The study successfully met its primary endpoint, demonstrating robust survival rates. The upcoming Phase 3 ORALTO trial will further explore MAT2203's efficacy as an oral step-down monotherapy following AmBisome treatment in patients with limited treatment options for invasive aspergillosis.

Matinas BioPharma is dedicated to developing cutting-edge therapies using its lipid nanocrystal (LNC) platform delivery technology. This innovative technology aims to offer safe and effective intracellular delivery of various molecular cargos, potentially establishing itself as a preferred next-generation oral drug delivery platform.