Invasive Candidiasis

What is Invasive Candidiasis?

Invasive candidiasis is a serious fungal infection caused by various Candida species and occurs most frequently in immunocompromised patients. Candida is the most common cause of healthcare-associated bloodstream infections in the U.S. (REF). The overall mortality rate of invasive candidiasis remains over 30%, despite therapy (REF).

Current treatment options are limited to only three antifungal classes, with few therapies becoming increasingly ineffective due to a rise in drug resistant strains. (REF)

The current treatment protocol/strategy for invasive candidiasis includes:

  • Empiric treatment in the hospital for suspected cases
  • Confirmed treatment in the hospital, typically for ICU, surgical patients, and immunocompromised patients, and patients using a central venous
  • Initial IV therapy for about five days (depending on the risk factors of the patient) with oral step-down for about two weeks

Ibrexafungerp for Invasive Candidiasis

Ibrexafungerp for Invasive Candidiasis

We are developing ibrexafungerp (formerly SCY-078) as an IV and oral antifungal therapy for the treatment of multiple invasive fungal infections. Ibrexafungerp’s unique combination of attributes potentially enable it to address significant unmet medical needs in treating invasive candidiasis:

  • Broad in vitro and in vivo anti-Candida activity
  • Active against azole- and most echinocandin-resistant Candida strains, including multidrug resistant strains, including C. auris
  • Developing in both oral and IV formulations, allowing first-line treatment and oral step-down with the same agent
  • Fungicidal activity vs. Candida
  • High tissue penetration, leading high concentrations in the organs commonly affected by fungal infections

“Invasive fungal infections will not go away any time soon. Therefore, we need to circumvent resistance to treatment by continued discovery and development of new antifungal agents and strategies.”

- Dr. John R. Perfect
Nature Reviews/Drug Discovery

Clinical Trial Results

Clinical experience to date has provided promising evidence of clinical antifungal activity of oral ibrexafungerp (formerly SCY-078) in patients with Candida infections.

(ClinicalTrials.gov Identifier: NCT02244606)

PK/Efficacy
  • Ibrexafungerp oral dose of 750mg QD identified, achieving target exposure in patients
  • 27 patients with invasive candidiasis enrolled in study
Safety/Tolerability
  • Safe and well-tolerated
  • Most common Adverse Events (AEs) were mild or moderate gastrointestinal (GI)-related events

Market Need

Despite existing antifungal agents, mortality in this high-risk patient population remains high (up to 30%). Additionally, the increasing emergence of drug-resistant Candida strains has created an urgent need for new treatments:

  • The CDC has listed fluconazole-resistant Candida as a serious threat requiring prompt and sustained action and has also identified a rise in echinocandin resistance, especially among Candida glabrata.
  • The CDC has issued an extraordinary alert for healthcare facilities and providers to be on the lookout for patients with C. auris, a multidrug-resistant strain with high mortality (approximately 60%).

Current treatment guidelines for invasive candidiasis recommend the use of IV echinocandins as first-line therapy for empiric and confirmed cases. If approved for the treatment of invasive candidiasis, Ibrexafungerp (formerly SCY-078) may provide an alternative to current IV echinocandin use and may fulfill the significant current unmet needs in the oral maintenance setting.

If Ibrexafungerp (formerly SCY-078) is approved for the treatment of invasive Candida infections, we believe it could complement or replace IV echinocandins as the drug of choice for these infections due to its broad spectrum of activity and its availability in both IV and oral forms. The flexibility of access to both formulations would allow physicians and their patients to start and stay on a single effective therapy for both inpatient and outpatient settings. Transitioning patients from hospital-based care to outpatient care is key to potentially reduce, or eliminate, expensive hospital stays and risks of hospital-acquired infections.