SCYNEXIS Inc (NASDAQ: SCYX) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company released positive results from a clinical study. As you could imagine, the positive results excited investors, leading to gains in the value of the stock. Today, we’ll talk about:
- The results;
- what we’re seeing from SCYX; and
- what we’ll be watching for ahead.
SCYX Releases Positive Clinical Results
As mentioned above, SCYNEXIS is having an incredibly strong start to the trading session this morning after releasing positive clinical results. In a press release issued early this morning, the company announced positive results from its Phase 2b clinical trial. During the dose-finding study, the company evaluated oral SCY-078 for the treatment of vulvovaginal candidiasis (VVC).
In the release, SCYX said that SCY-078 is the first representative of a novel oral and intravenous triterpenoid antifungal family. Currently, the treatment is in development for various serious fungal infections including VCC, invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections.
The study, dubbed the DOVE study, evaluated the safety and efficacy of five regimens of SCY-078. Total doses in the study ranged from 600mg to 1800mg and treatment duration ranged from one to three days. During the study, the company compared its findings to fluconazole (FLU), which is the standard of care in the current medical environment for VCC.
In the release, SCYX said that all five doses demonstrated meaningful clinical and mycological activity. Due to the data, the company believes that the smallest dose studied, 600mg SCY-078 is the optimal dose regimen moving into the Phase 3 registration study. In a statement, David Angulo, M.D., CMO at SCYX, had the following to offer:
The DOVE study accomplished its primary goal of identifying a well-tolerated oral dose regimen of SCY-078 with high clinical cure and mycological eradication rates… The positive effect of oral SCY-078 seen in this study was achieved at greatly reduced doses and with improved tolerability compared to our previous VVC Phase 2a study. The activity of SCY-078 in the DOVE study was consistent with that observed previously and with the fluconazole reference arm, providing reassurance of the validity of the findings across studies and confirming the clinically relevant antifungal activity of oral SCY-078 in this indication. We are looking forward to advancing our development program aiming to provide a much-needed oral treatment alternative for the growing segment of VVC patients in which current treatment options are not optimal or not approved, such as those with complicated cases, infections caused by azole-resistant organisms and recurrent VVC.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news causes the moves in the market. In the case of SCYNEXIS, the news proved to be overwhelmingly positive. With the strong data showing efficacy and tolerability at 600 mg, the company now believes that it has the dose dialed down and is ready to move into pivotal studies. So, it’s no surprise that excited investors are pushing the stock upward this morning. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (8:57), SCYX is trading at $1.92 per share after a gain of $0.27 per share or 16.36% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to follow SCYX incredibly closely. In particular, we’re interested in following the continued development surrounding SCY-078 and excited to see the company moving toward further catalystic events, including the full results from the DOVE study, the entrance into the Phase 3 study, completed enrollment, completed study, and more. There’s plenty to watch here! Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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