Matinas BioPharma Holdings, Inc., a clinical-stage biopharmaceutical company, has initiated enrollment and the first group of patients have been dosed in its phase 2 clinical study of lead anti-infective product candidate MAT2203 in patients with vulvovaginal candidiasis (VVC).
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 agent is administered and used in clinical practice.
This phase 2 study is a randomized, multicenter, evaluator-blinded study of oral MAT2203 compared to oral fluconazole in adult female patients. Approximately 75 patients with a diagnosis of moderate to severe VVC will be enrolled and randomized into three treatment cohorts of 25 patients each. The first cohort will receive treatment with 200 mg of oral MAT2203 while a second cohort will receive 400 mg of oral MAT2203. The third cohort will be treated with oral fluconazole. The study will assess the efficacy, safety and tolerability of MAT2203.
“The start of patient dosing in our second phase 2 study of MAT2203 is an important step forward in the advancement of the clinical development strategy for our proprietary cochleate formulation of amphotericin B,” said Roelof Rongen, chief executive officer.
“We anticipate that this study, along with the phase 2 of MAT2203 study ongoing at the NIH in severely immunocompromised patients suffering from mucocutaneous candidiasis, will provide further clinical evidence of MAT2203’s activity against candida infections. We believe this will place us in a favorable position to move into phase 3 registration trials with an intended first indication of prophylaxis, or prevention, of invasive fungal infections in patients on immunosuppressive therapy. We are excited to see MAT2203 progressing quickly into the clinic and look forward to reporting topline results from both of these studies in the first half of 2017,” added Rongen.
Matinas is also currently evaluating MAT2203 in a phase 2a open-label, dose-titration study being conducted at the National Institutes of Health Clinical Center in Bethesda, MD, under the direction of Principal Investigator Alexandra Freeman, M.D., of the National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Clinical Infectious Diseases for the treatment of mucocutaneous candidiasis. The study is designed to assess the efficacy, safety, tolerability and pharmacokinetics of MAT2203 in predominantly hereditary immunodeficient patients with a recurrent or chronic mucocutaneous candidiasis infection (esophageal, oropharyngeal, vaginal) who are refractory or intolerant to standard non-intravenous therapies.
The US Food and Drug Administration (FDA) has designated MAT2203 as a QIDP with Fast Track status for the treatment of invasive candidiasis, aspergillus and prophylaxis (prevention) of invasive fungal infections in patients on immunosuppressive therapy. MAT2203 is also being explored for treatment of additional infections, including cryptococcal meningoencephalitis, and is being developed to be eligible for Orphan Drug Designations in various indications.
Vulvovaginal candidiasis (VVC), more commonly known as a “yeast infection” is usually caused by Candida albicans, the most common cause of fungal infections worldwide. An estimated 75% of women will have at least one episode of VVC during their lifetime and 40-45% will have two or more. Current treatments for VVC include topical antifungals and the use of prescription oral antifungals such as fluconazole. According to the CDC, certain species of Candida are becoming increasingly resistant to existing antifungal medications. This emerging resistance intensifies the need for new antifungal agents.
MAT2203 is an orally-administered, encochleated formulation of amphotericin B (a broad spectrum fungicidal agent). Little to no clinical resistance has been reported to date with amphotericin B as compared to the rapidly emerging drug resistance seen in other antifungal therapies. Currently, IV-only administered amphotericin B is the only broad spectrum fungicidal available but its IV-delivery results in significant treatment-limiting side effects, including nephrotoxicity. The ability to provide amphotericin B via MAT2203’s proprietary and novel oral formulation may offer a new and promising alternative for patients and doctors. In a clinical Phase 1a single-dose, double-blind, dose-escalating, pharmacokinetic study of 48 healthy volunteers, oral MAT2203 demonstrated a positive safety and tolerability profile with no serious adverse events reported, including little or no nephrotoxicity as compared to placebo. Enrollment is currently underway for the Phase 2a NIH/NIAID-funded clinical study with MAT2203 in patients with refractory mucocutaneous candidiasis. The FDA has designated MAT2203 as a Qualified Infectious Disease Product for the treatment of invasive candidiasis, aspergillosis and prevention of invasive fungal infections due to immunosuppressive therapy. MAT2203 is also being explored for treatment of additional anti-fungal indications and may have the potential for Orphan Drug Designation in certain of these indications.
Matinas BioPharma is a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective broad spectrum therapeutics for the treatment of serious and life-threatening infections.