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MSG-10: a Phase 2 study of oral ibrexafungerp (SCY-078) following initial echinocandin therapy in non-neutropenic patients with invasive candidiasis.
Spec, Andrej; Pullman, John; Thompson, George R; Powderly, William G; Tobin, Ellis H; Vazquez, Jose; Wring, Stephen A; Angulo, David; Helou, Silvia; Pappas, Peter G.
Afiliação
  • Spec A; Washington University School of Medicine, St Louis, MO, USA.
  • Pullman J; Mercury Street Medical, Butte, MT, USA.
  • Thompson GR; University of California-Davis, Sacramento, CA, USA.
  • Powderly WG; Washington University School of Medicine, St Louis, MO, USA.
  • Tobin EH; Albany Medical Center, Albany, NY, USA.
  • Vazquez J; Medical College of Georgia/Augusta University, Augusta, GA, USA.
  • Wring SA; Scynexis, Inc., Jersey City, NJ, USA.
  • Angulo D; Scynexis, Inc., Jersey City, NJ, USA.
  • Helou S; Scynexis, Inc., Jersey City, NJ, USA.
  • Pappas PG; University of Alabama, Birmingham, AL, USA.
J Antimicrob Chemother ; 74(10): 3056-3062, 2019 10 01.
Article em En | MEDLINE | ID: mdl-31304536
ABSTRACT

OBJECTIVES:

To evaluate the safety and efficacy of two dosing regimens of oral ibrexafungerp (formerly SCY-078), a novel orally bioavailable ß-glucan synthase inhibitor, in subjects with invasive candidiasis versus the standard of care (SOC) and to identify the dose to achieve target exposure (15.4 µM·h) in >80% of the intended population.

METHODS:

In a multinational, open-label study, patients with documented invasive candidiasis were randomized to receive step-down therapy to one of three treatment arms two dosing regimens of novel oral ibrexafungerp or the SOC treatment following initial echinocandin therapy. Plasma samples were collected to evaluate exposure by population pharmacokinetic (PK) modelling. Safety was assessed throughout the study and global response at the end of treatment.

RESULTS:

Out of 27 subjects enrolled, 7 received ibrexafungerp 500 mg, 7 received ibrexafungerp 750 mg and 8 received the SOC. Five did not meet criteria for randomization. Population PK analysis indicated that an ibrexafungerp 750 mg regimen is predicted to achieve the target exposure in ∼85% of the population. The rate of adverse events was similar among patients receiving ibrexafungerp or fluconazole. Similar favourable response rates were reported among all groups 86% (n = 6) in the ibrexafungerp 750 mg versus 71% (n = 5) in both the fluconazole and ibrexafungerp 500 mg treatment arms. The one subject treated with continued micafungin had a favourable global response.

CONCLUSIONS:

The oral ibrexafungerp dose estimated to achieve the target exposure in subjects with invasive candidiasis is 750 mg daily. This dose was well tolerated and achieved a favourable global response rate, similar to the SOC.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Triterpenos / Equinocandinas / Candidíase Invasiva / Glicosídeos / Antifúngicos Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Antimicrob Chemother Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Triterpenos / Equinocandinas / Candidíase Invasiva / Glicosídeos / Antifúngicos Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Antimicrob Chemother Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos