We are developing our lead product candidate, SCY-078, as a novel oral and intravenous (IV) drug for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections. SCY-078 is a novel and structurally distinct triterpenoid glucan synthase inhibitor that has been shown to be effective in vitro and in vivo against a broad range of Candida and Aspergillus species, including drug-resistant strains. SCY-078 has also demonstrated in vitro activity against the multi-drug resistant pathogen Candida auris, which has been classified by the Centers for Disease Control and Prevention (CDC) as an emerging serious global health threat. Our first Phase 2 study of SCY-078 in patients with invasive candidiasis confirmed the achievement of plasma target exposures of SCY-078 and adequate tolerability after oral administration. In a completed Phase 2 study in patients with vulvovaginal candidiasis (VVC), SCY-078 showed clinical proof-of-concept against Candida infections in humans. SCY-078 is fungicidal against Candida through the inhibition of beta 1,3 D glucan synthesis in the cell wall of fungi resulting in cell death. SCY-078 is the only triterpenoid glucan synthase inhibitor with both oral and IV formulations in clinical development, with the potential to allow first-line treatment and oral step down in the same class.
Invasive fungal infections are an increasing problem for the healthcare system, with Candida and Aspergillus species responsible for approximately 85% of all invasive fungal infections in the United States and Europe. These infections occur in the sickest of patients, including those receiving chemotherapy for cancer or undergoing stem cell or organ transplants and are associated with significant morbidity and mortality. Candida ranks as the fourth most common hospital-acquired bloodstream infection in the United States. Recent data indicate a dramatic shift to Candida infections with increasing resistance to antifungal drugs, including azoles and echinocandins. There are few therapeutic alternatives for these multi-drug resistant infections. The CDC has listed fluconazole-resistant Candida as a serious threat requiring prompt and sustained action.
SCY-078 holds both Fast Track and Qualified Infectious Disease Product (QIDP) designations for the oral and IV formulations for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis. SCY-078 also holds Orphan Drug Designation (ODD) for both indications. These designations are designed to facilitate the development and expedite review of drugs by allowing companies to interact with the U.S. Food and Drug Administration (FDA) review team frequently. Additionally, the ODD of SCY-078 provides seven years of market exclusivity in the U.S. following FDA approval, which in conjunction with QIDP designation (which grants an additional five years of exclusivity) provides SCYNEXIS with a potential 12 years of market exclusivity upon FDA approval of SCY-078.
We believe that SCY-078 has the potential to play an important role in treating patients with invasive fungal infections, particularly those infected with resistant Candida and Aspergillus species. We are continuing to advance the development of SCY-078 for a number of antifungal infections and are planning additional non-clinical development activities to support our development program, including futher characterization of the antifungal spectrum of activity.
We may also develop SCY-078 as a treatment for recurrent VVC, commonly known as a "yeast infection," and have completed a Phase 2 proof-of-concept study in patients with VVC. The positive results provided evidence of the antifungal activity of orally administered SCY-078 in patients with Candida infections. 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 seven to nine percent 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.