By Ashley Skow, Texas A&M Innovation
Texas A&M startup Sano Chemicals has announced a major milestone for the first of its innovative drug products, OCF001, which has been approved by the U.S. Food and Drug Administration (FDA) for testing in humans in a Phase 1 clinical trial.
OCF001 is a formulated drug product containing occidiofungin and is being studied as an effective treatment for recurrent vulvovaginal candidiasis (RVVC). Occidiofungin is a potent broad spectrum fungicidal compound that Sano Chemicals is developing into a new treatment for drug-resistant fungal infections, of which there are no effective treatments currently available.
Dr. James Smith is a Texas A&M University biology professor whose work on occidiofungin began almost 15 years ago. Smith discovered occidiofungin in collaboration with Dr. Shien Lu and Dr. Frank Austin, professors at Mississippi State University, which led to the formation of Sano Chemicals.
“There are only a handful of new antifungal drug products in clinical trials and many of these belong to an existing class of antifungals,” said Smith. “Occidiofungin is a first-in-class antifungal and is effective against antimicrobial resistant fungi. FDA approval for Phase 1 clinical studies is very exciting and would not be possible without all the hard work from those at Sano Chemicals or the cooperation of The Texas A&M University System.”
RVVC, or chronic yeast infection, is defined as three or more confirmed infections over a 1-year period and occurs in up to 10% of women. A successful new drug could lead to widespread impacts.
“OCF001 has the potential to improve the quality of life for millions of women with RVVC. The impact of RVVC on the physical and emotional quality of life is overlooked and has serious debilitating effects on the health of those with the medical condition,” said Smith.
According to Smith, the FDA has also granted Sano Chemicals the Qualified Infectious Disease Product (QIDP) and Fast Track designations, which are only given to antimicrobial products that have potential to treat serious unmet medical conditions.
Occidiofungin shows great promise in treating the millions of people each year who are affected by severe fungal infections caused by drug resistant fungi. Sano Chemicals says it will continue to develop new drug products using occidiofungin for the treatment of dermal, oral, and invasive fungal infections.
Texas A&M Innovation at College Station works with a diverse array of partners – including entrepreneurs, investors, technology incubators, and large enterprises – to improve lives by commercializing innovations from The Texas A&M University System. Texas A&M research generates more than 300 new technologies each year, providing abundant and varied opportunities for industry collaboration. Learn more about the Texas A&M Innovation technology portfolio.