New vaginal yeast infection treatment enters phase 1 trial in US

According to the company, up to 9 million women in the U.S. suffer from RVVC, which is characterized as having three or more yeast infections per year.

RVVC is classified as an unmet medical need and Sano Chemicals has been granted Qualified Infectious Disease Product and Fast Track designations from the US Food and Drug Administration (FDA).

As a result, phase 1 clinical trials are currently underway to establish Occidiofungin as a cure for RVVC.

“The development of a drug product using Occidiofungin is supported by peer reviewed research and safety data. Occidiofungin is a first-in-class agent being developed for potential cure and worldwide use,” said James Leif Smith, co-CEO of Sano Chemicals.

The company is also developing additional products using Occidiofungin as a treatment for oral, dermal, and invasive infections that are in preclinical development.

Occidiofungin is fungicidal and is being developed as a cure for infection and not as a suppressive therapy.

However, existing yeast infection therapies on the market are suppressive and lead to increase in resistance to currently available antifungal drugs, Sano Chemicals said.

“RVVC is an unmet medical need that affects millions of women worldwide. This means that there is still no effective cure for a vast majority of women and the market opportunity for a drug product to treat RVVC is massive”, commented Janice Miles, co-CEO of Sano Chemicals.

Recruitment for the phase 1 study has commenced and trial enrollment is expected to be completed next month.