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 glucan synthase inhibitor that has been shown to be effective in vitro and in vivo in animal studies against a broad range of Candida and Aspergillus species, including drug-resistant strains, and showed clinical proof-of-concept against Candida infections in a completed Phase 2 study in patients with vulvovaginal candidiasis (VVC). SCY-078 is fungicidal for candida and works by inhibiting beta 1,3 D glucan synthesis in the cell wall of fungi resulting in cell death. SCY-078 is the only 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 Centers for Disease Control and Prevention (CDC) has listed fluconazole-resistant Candida as a serious threat requiring prompt and sustained action.
In early 2014, SCYNEXIS received from the FDA a Qualified Infectious Disease Product (QIDP) designation and Fast Track designation for the oral formulation of SCY-078 for the treatment of invasive candidiasis (including candidemia) and invasive aspergillosis. In 2016, we received both QIDP and Fast Track designations for the IV formulation of SCY-078 for the same indications. The QIDP designation for SCY-078 was made possible because Candida spp. and Aspergillus spp. were named qualifying pathogens under the Generating Antibiotic Incentives Now (GAIN) Act, Title VIII of the Food and Drug Administration Safety and Innovation Act. The GAIN Act provides companies with incentives to develop new antibacterial and antifungal drugs for the treatment of life-threatening infectious diseases caused by drug resistant pathogens.
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 currently working to progress SCY-078 in the clinic with a Phase 2 study of our oral formulation of SCY-078 in the treatment of invasive Candida infections, and anticipate beginning studies with an IV formulation of SCY-078 in 2015.
We are also developing SCY-078 as a treatment for (VVC, commonly known as a "yeast infection," and have completed Phase 2 proof-of-concept study. 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 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.