Overview

Study to Evaluate the Safety and Efficacy of the Coadministration of Ibrexafungerp (SCY-078) With Voriconazole in Patients With Invasive Pulmonary Aspergillosis

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
Study to evaluate the safety and efficacy of coadminstration of SCY-078 with a mold-active azole (voriconazole) compared to voriconazole in patients with invasive pulmonary aspergillosis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Scynexis, Inc.
Treatments:
Ibrexafungerp
Voriconazole
Criteria
Inclusion Criteria:

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 probable or proven IPA based on the protocol-specified criteria (Section
22.3) that requires antifungal treatment. Note: Subjects with possible IPA may enter
the screening phase of the study but will only be randomized after meeting criteria
for probable or proven IPA.

3. Subject has a result of a serum GMI from a sample obtained within the 96 hours
preceding enrollment into the study (Baseline/Treatment Day 1).

4. Subject has a diagnosis of a hematological malignancy or a myelodysplastic syndrome or
aplastic anemia or has undergone hematopoietic cell transplantation OR

5. Subject who either recently resolved or ongoing neutropenia (neutropenia defined as
absolute neutrophil count < 0.5 x 10⁹/L [< 500/mm³] for > 10 days), temporally related
to the onset of fungal disease OR

6. Subject who received treatment with other recognized T-cell immunosuppressants (such
as cyclosporine, tacrolimus, monoclonal antibodies or nucleoside analogs) during the
past 90 days including solid organ transplant patients OR

7. Subject with inherited severe immunodeficiency (e.g. chronic granulomatous disease,
severe combined immunodeficiency)

8. Subject has not received more than 4 days (96 hours) of prior mold-active antifungal
therapy for the treatment of the IPA episode in the 7 days preceding enrollment into
the study (Baseline/Treatment Day 1). However, subjects who have received more than 4
days but less than 7 days of prior mold-active antifungal therapy for the treatment of
the IPA episode in the 7 days preceding enrollment into the study may be enrolled but
will require approval from the study medical monitor, who will evaluate each subject
on a case-by-case basis.

9. Subject has an IPA episode that, in the investigator´s judgement, requires antifungal
therapy and may be adequately treated with voriconazole (i.e., the IPA is not a
breakthrough infection while receiving a mold-active azole antifungal [voriconazole,
posaconazole, isavuconazole or itraconazole] that requires therapy with a non-azole
antifungal agent).

Exclusion Criteria:

1. Subject has a fungal disease with central nervous system involvement suspected at
Screening.

2. Subject is receiving, has received or anticipates to be receiving concomitant
medications that are listed in the prohibited medication list (Appendix A in full
protocol) within the specified washout periods.

3. Subject has a Karnofsky score <20.

4. Subject is expected to die from a non-infectious cause within 30 days from the day the
study ICF is signed.

5. Subject is under mechanical ventilation.

6. Subject has abnormal liver test parameters: AST or ALT >5 x ULN and/or total bilirubin
>2.5 x ULN.