Scynexis buoyed by mid-stage data, new funding
- Scynexis, Inc. saw its stock climb in Thursday trading, after the New Jersey-based drug developer announced positive mid-stage results from two studies of its oral antifungal SCY-078. Shares jumped in value by as much as 15%, before paring back gains.
- Treatment with the drug led to better clinical cure rates and fewer recurrences of vulvovaginal candidiasis (VVC or yeast infection), compared to standard of care, according to data from one of two Phase 2 studies. The other study, testing SCY-078 in invasive candidiasis, also met its primary endpoint.
- Additionally, Scynexis said it had secured a $15 million term loan from Solar Capital, which will help fund development of SCY-078. Further clinical trials of the drug are planned for 2016 and 2017, with some analysts forecasting U.S. and E.U. launches by 2019 and 2020.
Yeast infections affect around 75% of women. But for many it is just a single uncomfortable episode that passes quickly. However, approximately 8% of women suffer from recurrent VVC, defined as four or more episodes a year, according to the company. Current treatments don't offer a great cure rate, and there is no approved treatment for recurrent infections.
Invasive candidiasis, on the other hand, is rarer but can be life-threatening, especially in people who are seriously ill or immunocompromised. The mortality rates are 20-40%, and the levels of resistant disease are increasing. The Centers for Disease Control and Prevention has described fluconazole-resistant Candida as a serious and significant public health threat that "requires prompt and sustained action to ensure the problem does not grow."
Scynexis is developing both oral and IV formulations of its antifungal SCY-078 to target these areas of unmet need. The Food and Drug Administration has granted fast track, qualified infectious disease product and orphan drug designations in the invasive candida and invasive aspergillus indications.
The Phase 2 trials give Scynexis some ammo proving the drug's efficacy and safety, and the study in invasive candidiasis confirmed the oral dosage for further study.
"These results support our planned development of SCY-078 as the first drug in a novel antifungal class for the treatment of a broad range of fungal infections with growing unmet medical needs," said David Angulo, chief medical officer at Scynexis
The four-year loan from Solar Capital bumps up Scynexis' cash holds to $58.4 million, bolstering the company's resources to fund R&D.
- Scynexis Statement
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