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Glucan Synthase Inhibitor

SCY-078 for Invasive Pulmonary Aspergillosis (SCYNERGIA Trial)

Phase 2
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 at day 42 and day 84
Awards & highlights

SCYNERGIA Trial Summary

This trial is testing whether combining SCY-078 with voriconazole is more effective and safe than voriconazole alone in treating patients with pulmonary aspergillosis.

Eligible Conditions
  • Invasive Pulmonary Aspergillosis

SCYNERGIA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 42 and day 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 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
Adverse events; discontinuation due to AE; death
Secondary outcome measures
Change in serum GMI
Composite clinical, radiological and mycological response (global response)
Death
+1 more

Side effects data

From 2018 Phase 2 trial • 186 Patients • NCT03253094
47%
Diarrhoea
25%
Nausea
16%
Abdominal pain
9%
Headache
6%
Blood creatine phosphokinase increased
3%
Abdominal pain upper
3%
Dizziness
3%
Somnolence
3%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibrexafungerp 750-mg
Ibrexafungerp 300-mg
Ibrexafungerp 450-mg
Ibrexafungerp 150-mg
Ibrexafungerp 300-mg D1 to D3
Fluconazole

SCYNERGIA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SCY-078 plus VoriconazoleExperimental Treatment2 Interventions
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards). PLUS Oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards). Treatment duration = minimum 6 weeks/Max 13 weeks
Group II: Voriconazole mono-therapyPlacebo Group2 Interventions
Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards). PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given QD from Day 3 onwards). Treatment duration = minimum 6 weeks/Max 13 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SCY-078
2014
Completed Phase 3
~370
Voriconazole
2008
Completed Phase 4
~5740

Find a Location

Who is running the clinical trial?

Scynexis, Inc.Lead Sponsor
17 Previous Clinical Trials
2,456 Total Patients Enrolled
1 Trials studying Invasive Pulmonary Aspergillosis
233 Patients Enrolled for Invasive Pulmonary Aspergillosis
David Angulo, MDStudy DirectorScynexis, Inc.
7 Previous Clinical Trials
1,168 Total Patients Enrolled
1 Trials studying Invasive Pulmonary Aspergillosis
233 Patients Enrolled for Invasive Pulmonary Aspergillosis

Frequently Asked Questions

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

Where is this trial being conducted?

"To date, this trial has recruited patients from 10 sites with locations in major cities such as Houston, Boston and Detroit. If you are considering enrolling, it is best to choose the site closest to your location to avoid extensive travel."

Answered by AI

How many people are being given this medication as part of the research?

"The sponsor, Scynexis, Inc., needs to recruit 60 patients that fit the clinical trial's inclusion criteria in order to start. The study will take place in different locations including Memorial Hermann Hospital Texas Medical Center Clinical Research Unit in Houston, Texas and Brigham Womens Hospital INF 75 Francis Street PBB-A4 in Boston, Massachusetts."

Answered by AI

Are there other ongoing experiments testing SCY-078's efficacy?

"The first SCY-078 trials were completed in 2008 at the Institute Rotary Cancer Hospital. There have been 80 such completed studies since then, with 11 more currently active and recruiting patients. Many of these newer trials are based out of Houston, Texas."

Answered by AI

What sorts of infections does SCY-078 usually target?

"SCY-078 is an antifungal medication used to treat aspergillosis, scedosporium infection, candidiasis, and other fungal infections."

Answered by AI

Are new participants being sought for this clinical trial?

"From what is available on clinicaltrials.gov, this trial is still taking in patients. The study was first made public on 1/22/2019 and the most recent update was 7/21/2022."

Answered by AI

Are there any risks associated with taking SCY-078?

"SCY-078 falls into the Phase 2 category, meaning that while there is evidence suggesting it is safe, there is no data to support its efficacy. Our team at Power gave it a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Safety and Efficacy of the Coadministration of Ibrexafungerp (SCY-078) With Voriconazole in Patients With Invasive Pulmonary Aspergillosis
2019. "Study to Evaluate the Safety and Efficacy of the Coadministration of Ibrexafungerp (SCY-078) With Voriconazole in Patients With Invasive Pulmonary Aspergillosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03672292.
~4 spots leftby Apr 2025
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