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SCYNEXIS passes US FDA orphan drug designation for SCY-078 for invasive aspergillus infections.

M2 EQUITYBITES-August 25, 2016-SCYNEXIS passes US FDA orphan drug designation for SCY-078 for invasive aspergillus infections


Drug development company SCYNEXIS (NasdaqGM:SCYX) revealed on Wednesday the receipt of the orphan drug designation from the US Food and Drug Administration (FDA) has for the novel triterpenoid broad-spectrum antifungal agent, SCY-078, for the treatment of invasive Aspergillus infections.

Invasive aspergillosis is a serious fungal infection caused by Aspergillus species that usually affects people who have weakened immune systems, such as people who have had an organ transplant or a stem cell transplant. Invasive aspergillosis most commonly affects the lungs, but it can also spread to other parts of the body.

The company said the SCY-078's orphan drug designation provides seven years of market exclusivity in the US following US FDA approval of an NDA for the orphan designated indication.This is the second US orphan designation received for SCY-078.

In conjunction, the company has received the Qualified Infectious Disease Product (QIDP) designation for both the IV and oral formulations of SCY-078, which provides an additional five years of exclusivity. Together, these designations provide SCYNEXIS with a potential 12 years of market exclusivity in the US upon US FDA approval.

According to the company, SCY-078 is an oral and IV glucan synthase inhibitor in Phase 2 clinical development for the treatment for fungal infections caused by Candida and Aspergillus species. SCY-078 combines the well-established activity of glucan synthase inhibitors (similar to echinocandins) with the flexibility of having intravenous (IV) and oral formulations (similar to azoles). SCY-078 has shown in vitro and in vivo activity against multi-drug resistant pathogens.

Additionally, the positive results from the company's recently reported Phase 2 proof-of-concept study in a mucocutaneous Candida spp. infection (acute vulvovaginal candidiasis) provided evidence of the antifungal activity of orally administered SCY-078 in patients with Candida infections.

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Publication:M2 EquityBites (EQB)
Date:Aug 25, 2016
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