Preclinical Development of OCF001 for Treatment of Yeast Infections

NIH RePORTER · NIH · R42 · $930,515 · view on reporter.nih.gov ↗

Abstract

Project Summary Occidiofungins (A-D) are cyclic nonribosomally synthesized antifungal peptides with submicromolar fungicidal activity against a broad spectrum of fungi. Optimization of the production and isolation of occidiofungins from liquid cultures has been performed. The production and isolation of predominantly one analog, called occidiofungin B (OCF001), supports its commercial development as a novel antifungal therapeutic. Several of the benchmarks used to evaluate the development of a novel therapeutic have been met with OCF001. OCF001 is a potent antifungal against fluconazole and caspofungin-resistant Candida species. It was also shown to be effective at inhibiting Candida auris at 0.25 g/ml. The antifungal triggers cell death by inducing apoptosis in yeast cells and was shown to have minimal toxicity in mice dosed with 2 mg/kg in a 28-day toxicity study. Furthermore, OCF001 was demonstrated to be an effective antifungal treatment for vaginal yeast infections in mice. All these studies point to the need to further the preclinical development of this novel compound. OCF001, along with very few antifungal compounds, have met any of these benchmarks, and therefore it holds promise as a potential antifungal therapeutic agent. The goal of this application is to complete the pre-Investigational New Drug (pre-IND) enabling and IND enabling studies for the development of an antifungal product for the treatment of systemic and vaginal yeast infections.

Key facts

NIH application ID
10146283
Project number
5R42AI131792-04
Recipient
SANO CHEMICALS, INC
Principal Investigator
James Leif Smith
Activity code
R42
Funding institute
NIH
Fiscal year
2021
Award amount
$930,515
Award type
5
Project period
2017-02-15 → 2022-12-31