SCY-078 represents a new chemical class of glucan synthase inhibitors designed to block an established target in infectious fungi by interfering with the assembly of the fungal cell wall and preventing the growth of medically important fungal species. SCY-078, prepared by chemical modification of enfumafungin, is the lead clinical candidate identified from this platform technology and is being developed as a new intravenous and oral agent for the treatment of several fungal infections, including life-threatening invasive fungal infections caused by Candida and Aspergillus species. SCY-078 is an inhibitor of fungal 1,3 – β -glucan and synthesis and shows antifungal activity against a wide range of clinically important fungi, including those that are resistant to azole drugs such as fluconazole.
We have completed a number of preclinical studies of the oral formulation of SCY-078 to demonstrate safety and efficacy. SCY-078 was well tolerated in several human Phase 1 studies at clinically relevant dose levels. We are currently conducting a Phase 2 study of oral SCY-078 as an oral step-down treatment in patients initially treated with IV echinocandin therapy for invasive Candida infections, and one for the treatment of vulvovaginal candidiasis (VVC). We are also conducting a single-rising-dose Phase 1 study of the IV formulation of SCY-078 in healthy volunteers. We also recently completed a Phase 2 proof-of-concept study of SCY-078 for the treatment of vulvovaginal candidiasis (VVC), designed to show evidence of antifungal activity of orally administered SCY-078 in patients with Candida infections. Positive results in this study confirmed the clinical relevance of antifungal activity of SCY-078.
SCYNEXIS is using its platform of enfumafungin derivatives and expertise to discover new compounds for the treatment of systemic and cutaneous fungal infections affecting humans.
About Invasive Fungal Infections
Hospital acquired fungal infections are an increasing problem for the healthcare system, with Candida and Aspergillus species being responsible for approximately 85% of all invasive fungal infections in the United States and Europe. Infections caused by Candida rank as the fourth most common hospital-acquired bloodstream infection in the United States and result in mortality rates of 20-40% depending on the immune status of the patient.
About Glucan Synthesis
The formation of glucan polymers is critical for fungal growth and inhibition of this process by the echinocandin class of drugs, e.g Cancidas®, is a clinically validated approach to antifungal therapy. However, echinocandins can only be administered parenterally, often requiring prolonged hospitalization for patients.
About Vulvovaginal Candidiasis
We are also developing SCY-078 as a treatment for vulvovaginal candidiasis (VVC), commonly known as a "yeast infection." VVC is caused by Candida albicans. An estimated 75% of women of reproductive age will have at least one episode of VVC during their lifetime and 40-45% will experience two or more episodes. As many as 7-9% of these patients suffer from recurrent VVC, or at least four episodes during a 12-month period. There are currently no products approved for recurrent VVC.