Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis

Scynexis

Status and phase: Completed; Phase 2

Conditions: Candidemia; Candidiasis, Invasive; Mycoses

Treatments: Drug: Micafungin; Drug: SCY-078; Drug: Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02244606

SCY-078-202

Details and patient eligibility

About

The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.

Full description

Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.

Enrollment: 27 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida.
• Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception.

Exclusion criteria

• Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis.
• Patient has failed treatment with an echinocandin for this episode of invasive candidiasis.
• Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture.
• Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

SCY-078 500 mg

Experimental group

Description:

A 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.

Treatment:

Drug: SCY-078

SCY-078 750 mg

Experimental group

Description:

A 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.

Treatment:

Drug: SCY-078

Standard-of-care

Active Comparator group

Description:

Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.

Treatment:

Drug: Fluconazole

Drug: Micafungin