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SCY-078

Phase 3

Candidiasis, Invasive | Small molecule | Other |SCYNEXIS, Inc.|Last Updated: Jul 3, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03363841Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)PHASE3 COMPLETED 30 — — Nov 15, 2017May 24, 2023Jul 3, 202412 United States, India +2
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Study Endpoints
Primary Endpoints
Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee
At (EoT) Visit (up to 90 days after Day 1)

The percentage of participants with global success at End of Treatment (EoT) as determined by the Data Monitoring Committee. Global success is defined as complete or partial resolution of signs and symptoms associated with the fungal disease and mycological eradication.

Secondary Endpoints
Percent of Participants With Treatment-emergent Adverse Events
Through study completion, up to 132 days
Number of Participants Discontinued Due to Adverse Events
Through study completion (up to 132 Days)
Percentage of Participants With Recurrence of Baseline Fungal Infection
42 Days after the End of Treatment visit
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SCY-078EXPERIMENTALSCY-078
Interventions
NameTypeDescription
SCY-078DRUGOral SCY-078
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Subject must fulfill the following KEY criteria to be eligible for study admission: 1. Subject is a male or female adult ≥ 18 years of age on the day the study informed consent form (ICF) is signed. 2. Subject has a documented candidiasis, including candidemia, caused by ...

Countries:United StatesIndiaPakistanSouth Africa
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