Invasive Aspergillosis

SCY-078 for Invasive Aspergillosis

Patients battling invasive aspergillosis, a serious fungal infection, face unsatisfactory clinical outcomes with mortality rates up to 50% and long treatment durations. Additionally, current therapies are associated with drug-drug interactions, and there is an increasing emergence of A. fumigatus resistance.

We believe SCY-078 may provide improved therapeutic outcomes when added to existing standard of care (azoles). SCY-078's attributes, including strong activity again Aspergillus strains, high lung penetration, convenient oral formulation, and low risk of drug-drug interactions, make it a promising agent to treat invasive aspergillosis.

What is Invasive Aspergillosis?

Invasive aspergillosis, a leading infection-caused death in immunocompromised patients, is a serious fungal infection caused by Aspergillus species. Current treatment guidelines recommend the use of azoles as the initial first-line therapy. However, patients face unsatisfactory clinical outcomes, with mortality rates up to 50% and long treatment durations. Current therapies also often exhibit drug-drug interactions, and the recent emergence of A. fumigatus azole resistance is increasingly becoming a clinical concern worldwide.

Due to the significant rate of resistance in some countries, combination antifungal therapy is recommended as first-line treatment for patients suspected of invasive aspergillosis. We believe that SCY-078's broad activity against Aspergillus spp., including azole-resistant strains, along with its minimal drug-drug interactions, high tissue penetration into the lungs and oral formulation allowing for long-term administration, may make it an ideal candidate for use as combination therapy.

Pre-Clinical Results

Pre-clinical results to date have been encouraging, indicating that combination therapy of SCY-078 and standard of care resulted in better efficacy vs. monotherapy for all efficacy parameters, including lower pulmonary infarct score and significant survival improvement.

If the combination of SCY-078 and standard of care is approved for the treatment of invasive Aspergillus infections and provides a significant improvement in clinical outcomes, SCY-078 as a combination therapy could replace the azole as the treatment of choice for this difficult-to-treat infection.

We recently reported data showing synergistic activity of SCY-078 in combination with an azole in both in vitro and in vivo models of invasive aspergillosis. A combination of SCY-078 and an azole would allow patients with invasive aspergillosis to receive this combination for the full 6 to 12 weeks of therapy, possibly leading to better outcomes.

Clinical Development Plan