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Glucan Synthase Inhibitor

SCY-078 for Invasive Candidiasis (CARES Trial)

Phase 3

Waitlist Available

Research Sponsored by Scynexis, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 42 and day 84

Awards & highlights

CARES Trial Summary

This trial is testing a new drug to treat Candida auris, a dangerous infection. The new drug is SCY-078 and it will be given to patients to see if it is effective, safe, and tolerated.

Eligible Conditions

Invasive Candidiasis
Candida Blood Infection

CARES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 42 and day 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 42 and day 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 42 and day 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy as measured by the percentage of subjects with global success at end of treatment

Secondary outcome measures

Number of participants with Discontinuations due to Adverse Events (Safety)

Number of participants with treatment-related Adverse Events (Safety)

Recurrence of Baseline Fungal Infection (Efficacy)

+1 more

Side effects data

From 2018 Phase 2 trial • 186 Patients • NCT03253094

47%

Diarrhoea

25%

Nausea

16%

Abdominal pain

Headache

Blood creatine phosphokinase increased

Abdominal pain upper

Dizziness

Somnolence

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Ibrexafungerp 750-mg

Ibrexafungerp 300-mg

Ibrexafungerp 450-mg

Ibrexafungerp 150-mg

Ibrexafungerp 300-mg D1 to D3

Fluconazole

CARES Trial Design

1Treatment groups

Experimental Treatment

Group I: SCY-078Experimental Treatment1 Intervention

SCY-078

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrexafungerp

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Scynexis, Inc.Lead Sponsor

17 Previous Clinical Trials

2,448 Total Patients Enrolled

David Angulo, MDStudy DirectorScynexis, Inc.

7 Previous Clinical Trials

1,160 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other scientific studies have included SCY-078 as a variable?

"SCY-078 is currently being researched in 4 different clinical trials, 3 of which are Phase 3 trials. The majority of the research for this treatment is based out of Sacramento, but there are 92 locations running trials for SCY-078."

Answered by AI

How many individuals are involved in this clinical trial?

"The information available on clinicaltrials.gov does say that this particular trial is looking for more participants as of today. This trial was first posted on November 15th, 2017 and the most recent update to the study was September 20th, 2021. They are recruiting for a total of 30 individuals from 1 site."

Answered by AI

Has the FDA given their stamp of approval to SCY-078?

"SCY-078 has been tested in multiple Phase 3 trials, so it is estimated to be safe."

Answered by AI

What is unique about this clinical trial?

"At the moment, there are 4 ongoing clinical trials for SCY-078 in 45 cities and 13 countries. The first study was sponsored by Scynexis, Inc. in 2017. That year, 200 patients completed Phase 3 drug approval stage. Since then, 9 more trials have concluded successfully."

Answered by AI

Are people still being signed up for this experiment?

"Yes, the trial is ongoing and currently looking for 30 individuals from a single location, as denoted by the most recent data on clinicaltrials.gov. The listing was created on November 15th 2017 but has undergone several edits, with the latest being on September 20th 2021."

Answered by AI

Recent research and studies

in VitroJournal

<i>in Vitro</i> Activity of a Novel Glucan Synthase Inhibitor, SCY-078, Against Clinical Isolates of Candida Auris

Berkow, Elizabeth L., David Angulo, and Shawn R. Lockhart. 2017. “in Vitro Activity of a Novel Glucan Synthase Inhibitor, SCY-078, Against Clinical Isolates of Candida Auris”. Antimicrobial Agents and Chemotherapy. American Society for Microbiology. doi:10.1128/aac.00435-17.

Antimicrobial Agents and ChemotherapyJournal

The Emerging Pathogen Candida Auris: Growth Phenotype, Virulence Factors, Activity of Antifungals, and Effect of SCY-078, a Novel Glucan Synthesis Inhibitor, on Growth Morphology and Biofilm Formation

Larkin, Emily, Christopher Hager, Jyotsna Chandra, Pranab K. Mukherjee, Mauricio Retuerto, Iman Salem, Lisa Long, et al.. 2017. “The Emerging Pathogen Candida Auris: Growth Phenotype, Virulence Factors, Activity of Antifungals, and Effect of SCY-078, a Novel Glucan Synthesis Inhibitor, on Growth Morphology and Biofilm Formation”. Antimicrobial Agents and Chemotherapy. American Society for Microbiology. doi:10.1128/aac.02396-16.

clinicaltrials.govStudy

Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)

2017. "Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03363841.