News Feature | November 6, 2014

SCYNEXIS Licenses SCY-635 To Waterstone For Viral Diseases

By Cyndi Root

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SCYNEXIS has licensed SCY-635 to Waterstone Pharmaceutical for the treatment of human viral diseases. SCYNEXIS announced the move in a press release, stating that it allows the company to focus on other compounds in development.

Yves J. Ribeill, Ph.D., President and CEO of SCYNEXIS, said, "The transitioning of SCY-635 to Waterstone allows us to focus on the development of our novel oral and IV product candidate, SCY-078, for the treatment of invasive fungal infections, which is entering a Phase 2 clinical trial this quarter.”

SCYNEXIS and Waterstone Agreement

Under the terms of the agreement between SCYNEXIS and Waterstone, SCYNEXIS extends worldwide development and commercialization rights to Waterstone for SCY-635. The license also includes an option for two additional cyclophilin inhibitors. Waterstone has agreed to make an upfront payment, milestone payments, and royalties.

SCY-635

SCY-635 is a derivative of cyclosporine A, a cyclophilin inhibitor that targets host proteins active in viral infections. The agent is part of SCYNEXIS’ cyclophilin inhibitor platform and was the first clinical candidate identified. The orally available agent has shown promise in treating Hepatitis C Virus (HCV). A Phase 1b proof-of-concept study of genotype 1 hepatitis C virus (HCV) was successful. A Phase 2a study for 28 days showed positive immune system modulation. SCYNEXIS was developing SCY-635 for a range of different viruses, including influenza and chronic Hepatitis B.

SCY-078

SCYNEXIS stated that it licensed SCY-635 to Waterstone in order to focus on CY-078 for fungal infections. The compound is derived from enfumafungins, a new class of natural product. The agent interferes with fungal species that attempt to modify the fungal cell wall. The company is developing the novel agent in oral and intravenous preparations for the Candida and Aspergillus species. SCYNEXIS states that the agent is active against a variety of fungi, even those that are resistant to azole drugs.

Pre-clinical studies of SCY-078 have shown safety and efficacy. A Phase 2 study titled, “Oral SCY-078 vs. Standard-of-Care Following IV Micafungin in the Treatment of Invasive Candidiasis” is underway. The safety, pharmacokinetics, and efficacy study expects to enroll 120 patients. In January 2014, the Food and Drug Administration (FDA) granted SCY-078 Qualified Infectious Disease (QIDP) status.