What is Vulvovaginal Candidiasis (VVC)?
VVC, commonly known as a vaginal yeast infection due to Candida, is the second most common cause of vaginitis.
Azoles are the only treatment class available for women suffering from VVC with no approved alternative class in the U.S. When a patient fails fluconazole therapy, patients typically are treated with more fluconazole or a topical azole. Women with VVC could benefit from a non-azole, and preferably oral, treatment option.
References: 1. Rosati D, Bruno M, Jaeger M, Ten Oever J, Netea MG. Recurrent Vulvovaginal Candidiasis: An Immunological Perspective. Microorganisms. 2020;8(2):144. Published 2020 Jan 21. 2. Denning DW, Kneale M, Sobel JD, Rautemaa-Richardson R. Global burden of recurrent vulvovaginal candidiasis: a systematic review. Lancet Infect Dis. 2018;18(11):e339-e347. 3. Sobel JD. Vulvovaginal candidosis. Lancet. 2007;369(9577):1961-1971. 4. Willems HME, Ahmed SS, Liu J, Xu Z, Peters BM. Vulvovaginal Candidiasis: A Current Understanding and Burning Questions. J Fungi (Basel). 2020;6(1):27. Published 2020 Feb 25. 5. Foxman B, Barlow R, D'Arcy H, Gillespie B, Sobel JD. Candida vaginitis: self-reported incidence and associated costs. Sex Transm Dis. 2000;27(4):230-235. 6. Aballéa S, Guelfucci F, Wagner J, et al. Subjective health status and health-related quality of life among women with Recurrent Vulvovaginal Candidosis (RVVC) in Europe and the USA. Health Qual Life Outcomes. 2013;11:169.
Ibrexafungerp for Vulvovaginal Candidiasis
We believe our product, Ibrexafungerp, has the potential to address vaginal yeast infections across a broad range of patients and could be an ideal treatment option for many patients for whom current treatment options are suboptimal. Despite yeast infections being so common and prevalent, with millions of women suffering from it every year, it is still an under-appreciated, under-reported, and under-served women’s health condition.
Ibrexafungerp, if approved, would be the first and only oral, non-azole treatment for vaginal yeast infections. Ibrexafungerp’s unique combination of features, including being from a novel class with a different mechanism of action, single-day BID oral dosing, broad spectrum, and fungicidal activity in all Candida species (albicans and non-albicans), including fluconazole-resistant strains such as Candida glabrata, will differentiate it from competing products. Brexafemme, the expected trade name for Ibrexafungerp, is under regulatory review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) action date of June 1, 2021.
Ibrexafungerp Key Attributes
“Many of the unresolved clinical issues in managing women with recurrent VVC would disappear if truly fungicidal drugs and regimens were available.”
- Dr. Jack D. Sobel
Current Infectious Disease Reports 2006,8:481–486
Clinical Trial Results
The VANISH Program (VANISH-303 and VANISH-306)
Highly Statistically Significant Superiority in Phase 3 VANISH Program
Ibrexafungerp met its endpoints and achieved statistically significant superiority vs. placebo
Two study visits: “Test-of-Cure” visit (TOC) at Day 10 and “Follow-Up” visit (FU) at Day 25
Signs and Symptoms [S&S] score defined as a composite endpoint of the subject’s reported symptoms (burning, itching and irritation) and the investigator’s assessed signs (swelling, redness and excoriations). Each sign and symptom can be absent, mild, moderate or severe, with a corresponding score from 0 to 3. The total composite scale goes from 0 to 18 points.
Sustained Efficacy at Follow-up Visit (Day 25) in VVC Clinical Studies (VANISH Phase 3 Program and DOVE Phase 2 Study)
- Consistent efficacy of ibrexafungerp across studies
- Sustained efficacy with high symptom resolution at Day 25
Safety and Tolerability Findings
In our VANISH Program, oral ibrexafungerp was generally safe and well tolerated. Severe and serious adverse events (AEs and SAEs) were rare, and there were no drug-related SAEs.
Similar to previous studies, the majority of Treatment-Emergent AEs (TEAEs) observed at a higher frequency in the ibrexafungerp group were gastrointestinal (GI) in nature, with the three most common GI events below. The majority of the GI AEs were mild to moderate, with most lasting one day.
The combined safety database of the VANISH and DOVE programs in VVC patients now includes more than 850 enrolled patients, with 575 treated with the one-day 600mg dose regimen of ibrexafungerp. The overall incidence of the most common GI events for ibrexafungerp-treated patients in the total database was 16.7% for diarrhea/loose stool, 11.8% for nausea, and 4.5% for abdominal pain, supporting the favorable safety and tolerability profile of ibrexafungerp.
Clinical Development Plan
In December 2020, we announced that the U.S. Food and Drug Administration (FDA) accepted our New Drug Application (NDA) for Ibrexafungerp for the treatment of VVC, with a Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021. The NDA is supported by positive results from our VANISH Phase 3 Program.
The CANDLE Phase 3 Study (ongoing) for the Prevention of Recurrent VVC
In March 2021, we completed enrollment in the CANDLE study (ClinicalTrials.gov identifier: NCT04029116).
