Trial Outcomes & Findings for Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections (NCT NCT03840616)

Last Updated: 2022-02-04

Results Overview

The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population, which includes subjects who failed to clear their initial acute VVC episode during the induction phase. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ≥3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome. 0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

219 participants

Primary outcome timeframe

48 Weeks

Results posted on

2022-02-04

Participant Flow

After providing consent, 251 subjects were screened and, of those, a total of 219 subjects were randomly assigned to the oteseconazole or fluconazole/placebo group for a 2-week induction phase. During the induction phase, subjects received either oteseconazole or fluconazole. Subjects whose presenting acute VVC episode resolved during the induction phase (a total of 185 subjects) entered a 48-week maintenance phase comprised of an 11-week treatment period and a 37-week follow-up period.

Of the 251 subjects screened, 32 did not meet eligibility requirements and were not enrolled (i.e., not assigned to a treatment arm for the 2-week induction phase).

Participant milestones

Participant milestones
Measure	Oteseconazole (VT-1161) 600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14.	Fluconazole / Placebo 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.
2-Week Induction Phase STARTED	147	72
2-Week Induction Phase COMPLETED	123	62
2-Week Induction Phase NOT COMPLETED	24	10
48-Week Maintenance Phase STARTED	123	62
48-Week Maintenance Phase COMPLETED	112	55
48-Week Maintenance Phase NOT COMPLETED	11	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oteseconazole (VT-1161) n=147 Participants 600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14.	Fluconazole / Placebo n=72 Participants 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.	Total n=219 Participants Total of all reporting groups
Age, Continuous	34 years STANDARD_DEVIATION 10.7 • n=5 Participants	36 years STANDARD_DEVIATION 11.7 • n=7 Participants	35 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	147 Participants n=5 Participants	72 Participants n=7 Participants	219 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	47 Participants n=5 Participants	27 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) White	88 Participants n=5 Participants	42 Participants n=7 Participants	130 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	147 participants n=5 Participants	72 participants n=7 Participants	219 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: Analysis was performed on the ITT population which includes subjects who failed to clear their initial acute VVC episode during the induction phase. The ITT population was defined as all randomized subjects. Missing values were imputed with multiple imputation using the following auxiliary information: treatment, baseline body mass index, baseline age, ethnicity, and visit. The 'percentage of participants' measure represents an average of 10 individual tests using multiple imputation.

Outcome measures

Outcome measures
Measure	Oteseconazole (VT-1161) n=147 Participants 600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14.	Fluconazole / Placebo n=72 Participants 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.
Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population	5.1 percentage of participants	42.2 percentage of participants

Adverse Events

Oteseconazole (Induction Phase)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Oteseconazole (Maintenance Phase)

Serious events: 3 serious events

Other events: 35 other events

Deaths: 1 deaths

Fluconazole (Induction Phase)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo (Maintenance Phase)

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oteseconazole (Induction Phase) n=146 participants at risk 600mg oteseconazole on Day 1 and 450mg oteseconazole on Day 2	Oteseconazole (Maintenance Phase) n=123 participants at risk 150mg oteseconazole once weekly for 11 weeks starting on Day 14.	Fluconazole (Induction Phase) n=72 participants at risk 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1	Placebo (Maintenance Phase) n=62 participants at risk Placebo once weekly for 11 weeks starting on Day 14.
Infections and infestations Appendicitis	0.00% 0/146 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.81% 1/123 • Number of events 1 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/72 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/62 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.
Infections and infestations Pneumonia	0.00% 0/146 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/123 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/72 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	1.6% 1/62 • Number of events 1 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.
Infections and infestations Pneumonia viral	0.00% 0/146 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.81% 1/123 • Number of events 1 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/72 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/62 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/146 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.81% 1/123 • Number of events 1 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/72 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/62 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/146 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.81% 1/123 • Number of events 1 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/72 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/62 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.
Blood and lymphatic system disorders Anaemia	0.00% 0/146 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.81% 1/123 • Number of events 1 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/72 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/62 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/146 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.81% 1/123 • Number of events 1 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/72 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/62 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.
Nervous system disorders Cerebrovascular accident	0.00% 0/146 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.81% 1/123 • Number of events 1 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/72 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/62 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.
Vascular disorders Deep vein thrombosis	0.00% 0/146 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.81% 1/123 • Number of events 1 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/72 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.	0.00% 0/62 • Day 1 through Week 50 The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.

Other adverse events

Additional Information

Clinical Trial Administration

Mycovia Pharmaceuticals Inc

Phone: 919-467-8539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Neither institution nor investigator can disclose information pertaining to study until sponsor issues multi-center publication. If multi-center publication is not issued within 18 months of study completion and database lock at all sites, sponsor has 30 days from receipt to review institution's and/or investigator's communication and can require removal of confidential information other than study data and/or delay release of institution's and/or investigator's communication for 60 days.
Publication restrictions are in place

Restriction type: OTHER