Drug developer Matinas BioPharma Holdings Inc (OTCQB:MTNB) has dosed first patients in its phase 2 clinical study of lead candidate MAT2203 to treat yeast infection in women.
The US FDA has already designated the drug as a qualified infectious disease product (QIDP) with fast track status for treating invasive candidiasis, aspergillus and prophylaxis (the prevention) of invasive fungal infections in patients on immunosuppressive therapy.
Around 75 patients with moderate to severe vulvovaginal candidiasis will be enrolled and split into three treatment cohorts of 25.
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 will receive oral fluconazole and the study will assess the efficacy, safety and tolerability of MAT2203.
Chief executive Roelof Rongen told investors: “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.
“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.”
He added he hoped this would place it favourably 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.”
An estimated 75% of women will have at least one episode of VVC during their lifetime and 40-45% will have two or more.
Story by ProactiveInvestors