Yeast Mycovia Study

Criteria for Inclusion:

• Subjects must be generally healthy, non-pregnant females 12 years of age and older as of Screening.
• Subjects must have a history of recurrent VVC as defined by three (3) or more episodes of acute VVC in the past 12 months, including the episode confirmed at Screening.
• Subjects must have a documented Pap test at Screening or within the current standard of care guidelines -Subjects must be suitable candidates for oral therapy and be able to swallow capsules intact.
• Subjects must be willing and able to provide written informed consent or assent (for those ages 12 to 17) and authorization for use of protected health information.
• Subjects of non-childbearing potential must meet the requirements defined below:
• Pre-menopausal with documentation of surgical sterilization (i.e., hysterectomy, bilateral tubal ligation, bilateral oophorectomy, or bilateral salpingectomy) at least 3 months prior to study entry.
• Post-menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments.
• Subjects of childbearing potential (includes ages 12-17) must use one method of contraception during the study through Week 48.

Criteria for Exclusion:

• Subjects must not have the presence of concomitant vulvovaginitis caused by other (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, or Neisseria gonorrhoeae) at Screening visit and at the Day 1 visit if an infection is suspected.
• Subjects must not have an active HPV infection as evidenced by visible condylomas on vulvovaginal examination at Screening and Day 1 visits.
• Subjects must not have the presence or a history of another vaginal or vulvar condition(s) that in the Investigator's opinion would confound the interpretation of clinical response.
• Subjects must not have a history of cervical cancer.
• Subjects must not use any systemic (e.g., oral or injectable) corticosteroid therapy during the study or within 30 days prior to Screening. However, use of topical (no vulvar or vaginal steroids), inhaled, ophthalmic, intraarticular and intralesional steroids is permitted.
• Subjects must not use any systemic (e.g., oral or injectable) or topical (applied to the vulva or vaginal area) antifungal, antibacterial, or antitrichomonal drugs during the study (unless prescribed by the Investigator or within 7 days prior to Screening.) -Subjects must not be using drugs with a narrow therapeutic index that are metabolized by CYP3A4 and sensitive to induction of CYP3A4 during the study (i.e. cyclosporine, fentanyl, quinidine, sirolimus and tacrolimus).
• Subjects must not use any vaginal estrogen replacement therapy, ospemifene, Vitamin E gel capsules (vaginally) or lubricants within 7 days prior to Screening.
• Subjects must not have a condition that would require treatment during the study with concomitant topical (applied to vulva and vagina) or systemic antimicrobial therapy for any reason.
• Subjects must not have received an immunosuppressive medication (e.g. cyclosporine, tacrolimus, methotrexate, 6-mercaptopurine, mycophenolate, etc.), or radiation therapy within 3 months prior to Screening or have a medical condition where it would be likely that the subject may need to use these therapies during the study.
• Subjects must not have evidence of any clinically significant major organ disease or current clinically significant infection or any other conditions (with the exception of acute VVC) that may affect the clinical assessment of RVVC per investigator judgment.
• Subjects must not have any condition that in the opinion of the investigator could impact drug absorption (e.g. gastrectomy, Roux-en-Y gastric bypass surgery, gastric bands or staples, etc.), distribution, or elimination.
• Subjects must not have poorly controlled diabetes mellitus -Subjects must not have moderate or severe hepatic and/or renal disease -Subjects of childbearing potential must not be pregnant (positive pregnancy test at Screening), lactating, or planning to become pregnant during the study period.
• Subjects must not have planned surgery or other medical procedures that in the Investigator's opinion would impact compliance with the protocol.
• Subjects must not have active substance abuse (e.g., drugs of any kind, including alcohol)or any other medical, psychiatric or social condition that in the Investigator's opinion would preclude compliance with the protocol.
• Subjects must not have received VT-1161 study medication in a previous study.
• Subjects must not have received any IMP in a clinical trial within 5 half-lives of that IMP prior to Screening (if unknown, 60 days prior to Screening).
• Subjects must not have a known history of intolerance or hypersensitivity to azole antifungal drugs (e.g., fluconazole, itraconazole, voriconazole, posaconazole, and isavuconazole), or any excipients of the capsule formulation.