Preclinical developent of an innovative drug candidate in systemic fungal therapy

The dataset documents results of studies in the area of drug development co-founded by the National Centre for Research and Development (Poland), grant number  POIR.01.01.01-00-1990/15-00, tytuł: Badania przedkliniczne i kliniczne kandydata na innowacyjny lek w terapii inwazyjnych grzybic układowych.

The objective of the project was to conduct preclinical and potantially Phase I clinical studies of a new compound to develop an innovative drug for treatment of invasive systemic mycoses. The compound will be selected from the group of innovative Amphotericin B derivatives developed during the BLIRT project co-funded under the 1.4–4.1 Innovative Economy Operational Programme, which have shown significant improvement of selective toxicity compared to the native drug. Moreover, the solubility of the compounds has been ensured, which enables their bioavailability. The innovative derivatives have characteristics of an ideal antifungal drug – fungicidal activity, low toxicity, aqueous solubility, no induction of resistance, activity against MDR strains, and a broad antifungal
spectrum. Their therapeutic efficacy has been preliminarily proven on a model of systemic candidiasis in mice.

The project was unsuccesful due to not enough competitive advantages of developed candidates regarding their antifungla efficacy and safety which did not justify further investments of both public and private funds.

The dataset contain reports from the conducted studies performed both in house but also in well established CROs. It cover the chemical sythesis of compounds, preparation of their liposomal formulations and preclinical studies in vitro and in vivo performed until the project was stopped, due to not achieving the set development milestone (preclinical stage). It is widely communicatd to the scientific community so that future projects could benefit form the generated know-how.