Development of novel oral formulation to treat systemic fungal infections

The Wasan Laboratory in the Faculty of Pharmaceutical Sciences at the University of British Columbia in partnership with iCo Therapeutics Inc. (Vancouver BC, Canada) have developed a novel oral formulation of Amphotericin B to treat systemic fungal and parasitic infections. Amphotericin B is a polyene macrolide antibiotic used in the treatment of blood borne fungal infections such as candidiasis and aspergillosis and parasitic infections such as visceral leishmaniasis. However, its effectiveness has been limited by dose-dependent nephrotoxicity, drug formulation costs, patient medication adherence and parenteral administration, which is not always accessible, costly and has additional toxicities associated with this route of administration. The rationale for the development of an oral amphotericin B formulation was that it could help overcome the aforementioned limitations by being less nephrotoxic, cost-effective, improve patient drug adherance and eliminate parenteral administration-associated costs and toxicities. The Wasan lab conducted in vitro cell culture studies and various animal studies to identify a lead formulation for clinical development. This lead formulation has recently successfully completed phase 1b human clinical trials and will start on phase 2 human clinical trials in comparing Oral Amp B to fluconazole in a head-to-head study in vulvovaginal candidiasis later in 2020. As noted in iCo Therapeutics recent press release Dr. Kishor Wasan, co-inventor of the Oral Amp B technology and Amphotericin B expert, noted that “traditionally Amphotericin B has been limited by an intravenous (IV) route of administration and limited therapeutic window. The impressive safety profile of Oral Amp B addresses one of two such limitations. I look forward to the initiation of a Phase 2 study in the near future which will investigate the efficacy of an oral version of Amphotericin B versus current standard of care, potentially addressing the second limitation of the current generic IV version of the drug.”

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