Refractory Invasive Fungal Infections

C. auris: A New Global Health Threat

C. auris, a new Candida strain, has been identified by CDC and other health authorities as a serious public health threat as it is multi-drug resistant, has resulted in high mortality rates (~60%) and can be spread from patients (and surfaces) to other patients, resulting in hospital outbreaks. In the U.S., there have been a small, but rapidly growing number of patients with C. auris infections.

Ibrexafungerp for Multidrug-Resistant Candida auris

Ibrexafungerp (formerly SCY-078) has shown fungicidal activity against clinically relevant Candida species and potent in vitro activity against strains of Candida that are resistant to azoles and echinocandins. We have an ongoing open label study evaluating the safety and efficacy of ibrexafungerp for the treatment of C.auris infections.

Development Status/Data to Date

The following clinical trials have potential eligibility for the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).

FURI Study

Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 in Patients with Refractory or Intolerant Fungal Diseases

Learn more here

CARES Study

Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 in Patients with Candidiasis Caused by Candida auris

This study is designed to provide rapid access to oral ibrexafungerp (formerly SCY-078) for C. auris patients. This emergency protocol allows for expeditious treatment initiation upon request from investigators.

Learn more here