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SCY-078

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

SCY-078 · 4 trials · 5 indications

Phase 3 1Phase 2 3
NCT03363841Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)Candidiasis, Invasive
COMPLETED30 Analytics
PHASE3COMPLETED
Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
Candidiasis, Invasive
NCT0336384130
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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.

Clinical Cure (Complete Resolution of Signs and Symptoms)
8-12 days

Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit

Proportion of subjects achieving therapeutic cure at the test of cure visit (Day 24 +/-3)
Day 24 +/- 3

Therapeutic Cure defined as achieving both a Clinical Cure (resolution of signs and symptoms) and a Mycological Eradication (negative culture).

Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements
up to 10 weeks

All Related TEAEs by SOC and PT, by Treatment, Safety

Dose of SCY-078 That Achieves the Target Exposure (AUC)
0 to 24 hours post-dose

Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK

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
FluconazoleACTIVE_COMPARATOR150 mg/day for 1 day
Ibrexafungerp 750mgEXPERIMENTAL750mg QD for 1 day only
Ibrexafungerp 300mgEXPERIMENTAL300mg BID for 1 day only
Ibrexafungerp 450mgEXPERIMENTAL450mg BID for 1 day only
Ibrexafungerp 150mgEXPERIMENTAL150mg BID for 3 days
Ibrexafungerp 300mg D1-D3EXPERIMENTAL300mg BID for 3 days
Treatment Group 1 (Fluconazole)ACTIVE_COMPARATORFluconazole
Treatment Group 2: (SCY-078)EXPERIMENTALDose regimen 1
Treatment Group 3 (SCY-078)EXPERIMENTALDose regimen 2
SCY-078 500 mgEXPERIMENTALA single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
SCY-078 750 mgEXPERIMENTALA single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
Standard-of-careACTIVE_COMPARATOROral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.

Interventions

NameTypeDescription
SCY-078DRUGOral SCY-078
FluconazoleDRUGOral Antifungal comparator
MicafunginDRUG -
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Eligibility Criteria

Age Range18 Years to 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 AfricaDominican RepublicEl SalvadorGermanyGuatemalaHonduras
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Frequently asked questions about SCY-078

What is SCY-078 used for?

SCY-078, also known as ibrexafungerp, is an investigational small molecule being developed for the treatment of fungal infections, including vulvovaginal candidiasis, invasive candidiasis, candidemia, and mycoses. It is being studied in patients with these conditions, with clinical trials evaluating its safety and efficacy compared to standard antifungal therapies.

What does SCY-078 target?

SCY-078 targets fungal cells by inhibiting the synthesis of glucan, a key component of the fungal cell wall. This mechanism disrupts cell wall integrity, leading to fungal cell death. It is being studied for its activity against various Candida species, including Candida auris, in clinical trials for invasive candidiasis and vulvovaginal candidiasis.

Who makes SCY-078?

SCY-078 is being developed by SCYNEXIS, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SCYX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating fungal infections, including invasive candidiasis and vulvovaginal candidiasis.

What phase is SCY-078 in?

SCY-078 has completed Phase 2 and Phase 3 clinical trials. Phase 2 trials evaluated the drug in invasive candidiasis and vulvovaginal candidiasis, while a Phase 3 trial (NCT03363841) assessed its efficacy in patients with candidiasis caused by Candida auris. All trials are completed, and the drug remains investigational.

What clinical trials is SCY-078 in?

SCY-078 has been studied in several completed clinical trials, including NCT02244606 (oral ibrexafungerp vs standard-of-care in invasive candidiasis), NCT02679456 (vs fluconazole in vulvovaginal candidiasis), NCT03253094 (dose-finding in acute vulvovaginal candidiasis), and NCT03363841 (open-label study in Candida auris candidiasis). These trials enrolled a total of 186 patients.

Is SCY-078 the same as ibrexafungerp?

Yes, SCY-078 is also known as ibrexafungerp. Clinical trial titles refer to the drug as oral ibrexafungerp (SCY-078), confirming that both names refer to the same investigational antifungal agent being developed by SCYNEXIS for the treatment of fungal infections.