# Preclinical Development of Occidiofungin for Treatment of Oral and Dermal Candidiasis

> **NIH NIH R42** · SANO CHEMICALS, INC · 2024 · $300,000

## Abstract

Project Summary
Occidiofungin is a cyclic nonribosomally synthesized antifungal peptide with submicromolar
fungicidal activity against drug resistant fungi. Optimization of the production and isolation of
occidiofungin from liquid cultures of this bacterium has been performed. Furthermore, detailed
structural determination, spectrum of activity, toxicity, and efficacy studies have been performed
on occidiofungin. Several benchmarks used to evaluate the development of a novel therapeutic
have been met with occidiofungin. Occidiofungin is a potent antifungal against fluconazole and
caspofungin-resistant Candida species. Occidiofungin triggers cell death by inducing apoptosis in
yeast cells. Occidiofungin has minimal toxicity in mice and GLP rodent micronucleus test (MNT)
demonstrated no genotoxicity. Additionally, occidiofungin was shown to be effective in treating
systemic and vaginal yeast infections in mice. All these studies point to the need to further the
preclinical development of this novel compound. Occidiofungin, along with very few antifungal
compounds, has met any of these benchmarks, and therefore it holds promise as a potential
antifungal therapeutic agent for the treatment of several fungal diseases. IND enabling studies for
an antifungal drug product to treat recurrent vulvovaginal yeast infections have been completed.
The goal of this application is to develop products for the treatment of drug resistant or recurrent
oral candidiasis (OC) and dermal candidiasis (DC). Establishing an effective formulation is
required before the toxicological and stability studies are performed as outlined in this proposal.
If the outlined studies prove to be successful, Sano Chemicals will file an IND application for an
occidiofungin based treatment for OC and DC infections.

## Key facts

- **NIH application ID:** 10919356
- **Project number:** 1R42AI184022-01
- **Recipient organization:** SANO CHEMICALS, INC
- **Principal Investigator:** James Leif Smith
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $300,000
- **Award type:** 1
- **Project period:** 2024-07-05 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10919356

## Citation

> US National Institutes of Health, RePORTER application 10919356, Preclinical Development of Occidiofungin for Treatment of Oral and Dermal Candidiasis (1R42AI184022-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10919356. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*