Sano Chemicals Inc. (DBA "Sano Women's Health") Announces Approval to Start Phase 1 MAD Study
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BRYAN, Texas - Txylo -- Sano Women's Health has received investigational new drug approval from the FDA, for Occidiofungin, a first-in-class novel peptide with broad antifungal activity. The FDA has also granted qualified infectious disease product (QIDP) and Fast-Track designations for the RVVC drug product given that this is an unmet medical need. RVVC affects up to 9 million women annually in the US and about 130 million women worldwide. Occidiofungin showed positive results in Sano's recent Single Ascending Dose (SAD) Phase 1 clinical trials. Sano is targeting to start the Phase 1 Multi Ascending Dose (MAD) study in the first quarter of 2025.
To date, Sano has raised $8 million dollars from NIH and angel investors. Sano has recently been approved to raise up to $5 million on the StartEngine platform. Start Engine is one of the largest equity crowdfunding platforms in the world, and Start Engine is advised by Shark Tank's Kevin O'Leary. Sano has raised over $200,000 in the first few weeks of being on this platform. "These proceeds will be used to fund the Phase 1 MAD studies starting in the first quarter of 2025," said Dr. Jim Smith, President and Co-CEO of Sano.
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The Phase 1 MAD study is expected to be completed by the end of Q3, 2025.
ABOUT SANO CHEMICALS
Sano Chemicals is a clinical-stage company developing new chemical entities for providing an effective treatment for those with unmet medical needs. Novel agents are in development that intend to lessen the burden of multidrug resistant infectious diseases and cancer. Sano Chemicals is also developing new first-in-class antibacterial agents that have a dual mechanism of action against bacteria that have developed resistance to currently available antibiotics. A drug product containing the antifungal Occidiofungin is being developed as a cure for recurrent vulvovaginal candidiasis (RVVC). Occidiofungin is designated as a Qualified Infectious Disease Product (QIDP) and has been Fast Tracked by the FDA.
For more information, please visit www.sanochemicals.com
To date, Sano has raised $8 million dollars from NIH and angel investors. Sano has recently been approved to raise up to $5 million on the StartEngine platform. Start Engine is one of the largest equity crowdfunding platforms in the world, and Start Engine is advised by Shark Tank's Kevin O'Leary. Sano has raised over $200,000 in the first few weeks of being on this platform. "These proceeds will be used to fund the Phase 1 MAD studies starting in the first quarter of 2025," said Dr. Jim Smith, President and Co-CEO of Sano.
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The Phase 1 MAD study is expected to be completed by the end of Q3, 2025.
ABOUT SANO CHEMICALS
Sano Chemicals is a clinical-stage company developing new chemical entities for providing an effective treatment for those with unmet medical needs. Novel agents are in development that intend to lessen the burden of multidrug resistant infectious diseases and cancer. Sano Chemicals is also developing new first-in-class antibacterial agents that have a dual mechanism of action against bacteria that have developed resistance to currently available antibiotics. A drug product containing the antifungal Occidiofungin is being developed as a cure for recurrent vulvovaginal candidiasis (RVVC). Occidiofungin is designated as a Qualified Infectious Disease Product (QIDP) and has been Fast Tracked by the FDA.
For more information, please visit www.sanochemicals.com
Source: Sano Chemicals
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