Major progress towards an all oral treatment strategy.

Drug discovery company SCYNEXIS, Inc. today presented data demonstrating that SCY-635—a novel, oral cyclophilin inhibitor being studied for the treatment of hepatitis C virus (HCV) infection—reactivates the body’s natural defense mechanism, making it capable of inhibiting replication of the virus. The data positions SCY-635 as a potential replacement for recombinant interferon—a component of the standard of care for hepatitis C treatment that is associated with significant side effects. The data were presented in a poster session at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco. SCY-635 is currently undergoing Phase 2 studies.

The results of this study introduce a completely novel mechanism to treat HCV and suggest that our oral cyclophilin inhibitor, SCY-635, could potentially replace recombinant interferon—a primary goal in the development of new treatment protocols for this disease,” said Yves Ribeill, Ph.D., President and Chief Executive Officer of SCYNEXIS. “HCV is a complex disease where the virus cloaks and hides itself from the body’s immune system. SCY-635 uncloaks the virus – making it visible to the immune system. In studies conducted to date, SCY-635 has been well-tolerated and demonstrated single-agent, clinically meaningful activity. It has also demonstrated an excellent in vitro drug – drug interaction profile with other approved products and leading products in clinical development, suggesting that SCY-635 could play an important role in the quest for a new standard of care in HCV.

This is different than other therapeutic approaches to eradicating HCV because SCY-635 acts primarily at the level of the host innate immune response pathway,” said Sam Hopkins, Ph.D., Chief Scientific Officer of SCYNEXIS. “Acting predominantly at the level of a host target, cyclophilin A, lessens the likelihood of developing resistance which is typically associated with direct acting antiviral agents.

In the poster presentation entitled, “The Non-Immunosuppressive Cyclophilin Inhibitor SCY-635 Exerts Clinical Anti-HCV Activity by Up Regulating the Expression of Endogenous Interferons,” SCYNEXIS demonstrated that treatment with SCY-635 monotherapy resulted in dose and concentration dependent increases in the plasma protein concentrations of multiple endogenous interferons including interferon alpha and interferon lambda-1 in patients chronically infected with genotype 1a hepatitis C virus. The upregulated expression of multiple interferons was associated with increased expression of interferon stimulated genes . The data also show a correlation of SCY-635 plasma levels and the expression of type 1 and type 3 interferons; the presence of these interferons demonstrate that the body is now able to respond to the virus.

SCYNEXIS also presented two additional studies of SCY-635 at AASLD. In one study, SCYNEXIS showed that consistent with the clinical observations, SCY-635 results in an increased expression of multiple type 1 and 3 interferons in vitro and that SCY-635 is equally as effective as IFNα-2b in clearing HCV and preventing viral rebound in vitro. The final study examined potential drug interactions between SCY-635 and telaprevir and demonstrated that SCY-635 presented a lower risk of potential adverse drug-drug interactions when compared in vitro with other cyclophilin inhibitors.

About SCY-635 and SCYNEXIS’ Cyclophilin Inhibitor Platform
SCY-635 represents a new class of therapeutic agents for the treatment of HCV infection. SCY-635 is the first candidate in a novel class of non-immunosuppressive, oral cyclophilin inhibitors owned by SCYNEXIS. Cyclophilins are a family of enzymatic proteins that assist in the folding and transport of other proteins synthesized within a cell. Scientists at SCYNEXIS have synthesized derivatives of Cyclosporine A in which cyclophilin binding activity (which mediates anti-HCV activity) is separated from calcineurin binding activity (which mediates immunosuppression). A growing body of scientific evidence indicates that non-immunosuppressive analogs of Cyclosporine A may have applications in multiple therapeutic areas.
Cyclophilins play a central role in the pathophysiology of chronic viral infection, neuro- and cardio-degenerative diseases. Cyclophilin inhibition therefore represents an attractive target for drug discovery and development.

SCYNEXIS is a premier drug discovery and development company delivering effective and innovative drug pipeline solutions to pharmaceutical and global health partners. Our record of success is demonstrated by the delivery of 11 pre-clinical and clinical drug candidates over the last 5 years. The Company, which is located in Research Triangle Park, North Carolina, is developing a proprietary internal pipeline based on cyclophilin inhibitors, a class of drugs that hold significant potential for the treatment of a broad range of diseases.
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