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Developing a better drug and treatment for vaginal yeast infections
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Sano Chemicals is pioneering antifungal innovation with its flagship product, OCF001. The first part of Phase 1 FDA human trials to treat recurrent vulvovaginal candidiasis (RVVC) has been successfully completed. Sano Chemicals is working to bring this innovative treatment to market, pending successful clinical trials and regulatory approval. RVVC is associated with chronic and recurrent yeast infections affecting up to 9 million women in the U.S. per year. FDA has granted Sano Chemicals qualified infectious disease product (QIDP) designation for its RVVC drug, which extends market exclusivity five years. Sano Chemicals believes it's poised to address a multi-billion U.S. market for treating recurrent and drug-resistant vaginal yeast infections.
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Sano Women's Health is focused on developing safer and more effective treatments for infections that affect the quality of life for millions of women. Vaginal yeast infections are becoming more difficult to effectively treat given the rise in resistance to current antifungal treatments. For the past several decades, bacteria and fungi have been acquiring resistance to current drugs, requiring the development of new drugs to stay ahead of the evolutionary curve.
OCF001
OCF001
OCF001 is under investigation as a response to increasing prevalence of antifungal resistance. Its unique mechanism of action suggests great potential in the fight against drug resistant fungi. FDA has approved an investigational new drug application (INDA) allowing Phase 2 clinical trials.
The Problem
The Rising Threat of Drug-Resistant Fungal Infections
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Over 130 million women globally and up to 9 M women in U.S. per year suffer from recurrent vulvovaginal candidiasis (RVVC).
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Yeast Infections have become resistant to the current standard of care.
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Existing treatments are suppressive and fungistatic.
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Recurrence of infection is common following treatment.
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Concurrent therapies may be prescribed.
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Systemic exposure to current treatments results in increased complication rate, renal and liver abnormal labs, discomfort, uneasiness, and loss of intimacy.
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Systemic exposure of antifungals is contraindicated in childbearing years.
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Until recently, there have been no new therapies with a new mechanism of action to treat these infections in over 20 years.
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Why Sano Women's Health
We offer an innovative solution for the treatment of recurrent vulvovaginal candidiasis (RVVC)
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Occidiofungin - The Fungus Killer - is rapidly fungicidal and has demonstrated activity against drug resistant yeast.
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Occidiofungin - The Fungus Killer - is rapidly fungicidal and has demonstrated activity against drug resistant yeast.
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Major pharmaceutical companies have expressed interest in our innovative treatment for vaginal yeast infections.
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Occidiofungin treats the site of infection without side effects on other organs. There is no discernable absorption of occidiofungin from the vaginal cavity.
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Occidiofungin was shown to have no fetal toxicity in a dose range study.
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Occidiofungin has no antibacterial activity and may help restore the normal bacterial flora of the vaginal cavity. A healthy microbiota provides protection against reinfection.
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Our Solution
A Potential Breakthrough in Antifungal Innovation for the treatment of RVVC
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SAN01, a first-in-class fungicidal drug that rapidly eliminates fungal infections without harming beneficial microbiota.
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Potent fungicidal activity against all vaginal yeast (Candida spp.)
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No concurrent therapies needed
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3 or 5-day intravaginal application at the site of infection
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No discernable absorption from vaginal cavity preventing unwanted complications
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Favorable preclinical drug safety profile
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Initial Phase 1 clinical trials did not identify serious adverse events, based on preliminary data, and found the treatment to be easily administered. No reports of discomfort or other significant events occurred.
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Interest expressed by pharmaceutical companies following completion of Phase 2 studies.
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Sano aims to revolutionize the treatment of vaginal yeast infections and capture a meaningful share of the $4–5 billion global yeast market, subject to clinical success and market dynamics.
OCF001 - Intravaginal Treatment for RVVC
Sano Women's Health is pioneering antifungal innovation with its flagship product to treat recurrent vulvovaginal candidiasis (RVVC) using OCF001. The first part of Phase 1 FDA human trials to treat recurrent vulvovaginal candidiasis (RVVC) has been successfully completed. Sano Women's Health is working to bring this innovative treatment to market, pending successful clinical trials and regulatory approval. RVVC is associated with chronic and recurrent yeast infections affecting up to 9 million women in the U.S. per year. FDA has granted Sano Women's Health qualified infectious disease product (QIDP) designation for its RVVC drug, which extends the market exclusivity for five years. Sano women's Health believes it's poised to address a multi-billion U.S. market for treating recurrent and drug-resistant vaginal yeast infections.
