Matinas BioPharma Initiates Enrollment And Commences Patient Dosing In Phase 2 Study Of MAT2203 For The Treatment Of Vulvovaginal Candidiasis

- Second Phase 2 study of lead anti-infective candidate MAT2203 -

- On track to report Phase 2 topline data for MAT2203 in the first half of 2017 -

BEDMINSTER, N.J., Nov. 21, 2016 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (OTCQB:MTNB), 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, announced today that it 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 Mr. Rongen.