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BOLD and rigorous clinical evaluation

Clinical trial design1

The efficacy and safety of BREXAFEMME were evaluated in 2 randomized, multicenter, double-blind, placebo-controlled phase 3 clinical trials of similar design (Trial 1 and Trial 2).

KEY INCLUSION CRITERIA

Non-pregnant postmenarchal females with a diagnosis of VVC meeting the following criteria:

  • Composite VSS minimum score of ≥4 with at least 2 signs or symptoms having a score of 2 (moderate) or greater
  • Positive microscopic exam with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts
  • Normal vaginal pH (≤4.5)

TREATMENT

Single day of BREXAFEMME 600mg (two 150 mg tabs per dose, administered 12 hours apart).

PRIMARY ENDPOINT

Percentage of subjects with complete clinical response (VSS score of 0) at Day 10.

ADDITIONAL ENDPOINT

Sustained resolution of VVC signs and symptoms at Day 25.

Evaluated in a wide range of patient types.

Trial 1
(BREXAFEMME: n=190; placebo: n=100)
Trial 2
(BREXAFEMME: n=189; placebo: n=89)
Average age 34 (min 17, max 67) 34 (min 18, max 65)
<50 years old 91% 92%
White 54% 81%
Black or African American 40% 19%
Hispanic/Latina 26% 10%
Average BMI 30 26
History of diabetes 9% 5%
Median VSS score at baseline 9 (min 4, max 18) 10 (min 4, max 18)
% culture positive with Candida albicans 92% 89%
Trial 1
(BREXAFEMME: n=190; placebo: n=100)
Average age
34 (min 17, max 67)
<50 years old
91%
White
54%
Black or African American
40%
Hispanic/Latina
26%
Average BMI
30
History of diabetes
9%
Median VSS score at baseline
9 (min 4, max 18)
% culture positive with Candida albicans
92%
Trial 2
(BREXAFEMME: n=189; placebo: n=89)
Average age
34 (min 18, max 65)
<50 years old
92%
White
81%
Black or African American
19%
Hispanic/Latina
10%
Average BMI
26
History of diabetes
5%
Median VSS score at baseline
10 (min 4, max 18)
% culture positive with Candida albicans
89%

Data reflect the modified intent to treat (mITT) efficacy population which included randomized subjects with a baseline culture positive for Candida species who took at least 1 dose of study medication.

BMI=body mass index; VSS=vulvovaginal signs and symptoms.

Brust

Why evaluate efficacy using the VSS score?1

The VSS scale provides a comprehensive assessment of hallmark signs and symptoms of vaginal yeast infections, including:

  • Erythema
  • Edema
  • Excoriation
  • Itching
  • Burning
  • Irritation
  • These are rated from 0 (absent) to 3 (severe), with signs assessed by the healthcare provider and symptoms assessed by the patient, for a total score ranging from 0 to 18

Studied in patients with moderate-to-severe VSS5

94

of patients at baseline had a VSS score of ≥7

No signs
or symptoms

0

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

1718

Severe signs
and symptoms

Indication

BREXAFEMME® is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC).

Important Safety Information

  • BREXAFEMME is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp
  • BREXAFEMME administration during pregnancy may cause fetal harm based on animal studies. Prior to initiating treatment, verify pregnancy status in females of reproductive potential and advise them to use effective contraception during treatment
  • When administering BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice a day for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided
  • Most common adverse reactions observed in clinical trials (incidence ≥2%) were diarrhea, nausea, abdominal pain, dizziness, and vomiting

To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Patient Information.

References: 1. BREXAFEMME. Prescribing Information. SCYNEXIS, Inc.; 2021. 2. Scynexis, Inc. Updated June 2, 2021. Accessed July 2, 2021. https://www.scynexis.com/news-media/press-releases/detail/240/scynexis-announces-fda-approval-of-brexafemme. 3. Pappas PG, Kauffman CA, Andes DR, et al. Clinical Practice Guideline for the management of candidiasis: 2016 Update by the Infectious Diseases Society of America. Clin Infec Dis. 2016;62(4):e1–50. 4. Gintjee TJ, Donnelley MA, Thompson GR 3 rd . Aspiring antifungal: review of current antifungal pipeline developments. J Fungi (Basel). 2020:6(1):28 doi:10.3390/jof601028. 5. Data on file [1]. SCYNEXIS, Inc., Jersey City, NJ. 6. Data on file [2]. SCYNEXIS, Inc., Jersey City, NJ. 7. Data on file [3]. SCYNEXIS, Inc., Jersey City. NJ. 8. Data on file [4]. SCYNEXIS, Inc., Jersey City. NJ.

Important Safety Information

Indication

  • BREXAFEMME is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp
  • BREXAFEMME administration during pregnancy may cause fetal harm based on animal studies. Prior to initiating treatment, verify pregnancy status in females of reproductive potential and advise them to use effective contraception during treatment
  • When administering BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice a day for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided
  • Most common adverse reactions observed in clinical trials (incidence ≥2%) were diarrhea, nausea, abdominal pain, dizziness, and vomiting

To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Patient Information.

BREXAFEMME® is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC).