Matinas biopharma holdings, inc initiates enact study of mat2203 (oral amphotericin b) for the treatment of fungal cryptococcal meningitis

Matinas biopharma holdings, inc. announced that it has initiated its phase 2 enact clinical study, which will explore the use of mat2203 for both induction and maintenance therapy in hiv-patients with cryptococcal meningitis, a life-threatening fungal infection most commonly observed in immunocompromised individuals. enact (encochleated oral amphotericin for cryptococcal meningitis trial) is an open-label, sequential cohort study, financially sponsored by the national institutes of health (nih) with david boulware, m.d., m.p.h, professor of medicine at the university of minnesota acting as principal investigator for the study in collaboration with dr. david meya, ph.d. of makerere university. this trial utilizes mat2203, which applies the company’s lnc drug delivery technology to orally deliver amphotericin b, an otherwise iv-only, highly toxic, fungicidal drug for the treatment of hiv-patients with cryptococcal meningitis. oral mat2203 is designed to target delivery directly to infected tissues, protecting the body from unnecessary exposure to amphotericin b, and is expected to be a safer alternative to the traditional iv-forms of this highly potent drug with a lower propensity for renal toxicity. the study consists of two distinct parts; part 1 is designed to determine the maximum tolerated dose among people living with hiv but who do not have a fungal infection. part 2 is a prospective randomized trial evaluating the safety, tolerability and efficacy of mat2203 in hiv-infected patients with cryptococcal meningitis, compared to treatment with standard iv-administered amphotericin b as induction therapy. as previously reported, the food and drug administration (fda) has designated mat2203 as a qualified infectious disease product (qidp) with fast track status for four indications, specifically, the prevention of invasive fungal infections due to immunosuppressive therapy, and the treatment of invasive candidiasis, invasive aspergillus and cryptococcal meningitis. in addition, the fda granted orphan drug designation to mat2203 for the treatment of cryptococossis. adding orphan drug designation to the qidp for the treatment of cryptococcal meningitis, which is within the scope of this fda-granted orphan drug designation, potentially positions mat2203 for up to 12 years of marketing exclusivity, if approved.
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