Drug development company Scynexis has announced the complete results of its two recently completed phase II studies as well as the closing of a $15 million term loan with Solar Capital.
In the first study, treatment with oral SCY-078 in patients with vulvovaginal candidiasis (VVC), resulted in significantly better clinical cure rates and fewer recurrences of VVC at the four-month follow-up when compared to the standard of care (oral fluconazole). In the second study, which evaluated oral SCY-078 as a step down therapy in patients with invasive candidiasis, oral SCY-078 achieved the target exposure for efficacy and was well-tolerated.
"We are delighted with these positive results that support the concept that a fungicidal product with high tissue penetration like SCY-078 could yield superior clinical outcomes," said David Angulo, M.D., chief medical officer of Scynexis. “We identified a well-tolerated oral dose that achieves our target exposure in invasive candidiasis patients, and further confirmed the antifungal activity of oral SCY-078 in two independent human models of Candida infections. 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.”
The first study evaluated the effect of two dose regimens of SCY-078 in patients with moderate to severe VVC as a proof-of-concept study to support the development of SCY-078 in invasive candidiasis and other Candida infections. Clinical cure rate, defined as a resolution of signs and symptoms of infection without further antifungal treatment, is now the recommended primary endpoint per the latest FDA guidelines for VVC.
As previously reported, clinical cure rate was higher for patients receiving oral SCY-078 compared to oral fluconazole at the test of cure visit (Day 24). Additionally, follow-up data now available showed a high clinical cure rate at the four-month visit (end of observation period) of 88% in patients who received SCY-078 compared to 65% in patients who received fluconazole (p=0.04). Moreover, during the four-month observation period, patients who received SCY-078 had a lower recurrence rate (4%) versus fluconazole (15%).
The second study evaluated the pharmacokinetics (PK), safety and tolerability of SCY-078 as an oral step-down treatment in patients initially treated with intravenous (IV) echinocandin therapy for invasive Candida infections. Twenty-two patients were randomized to receive study drug or standard of care (one of the patients randomized to standard of care could not receive oral fluconazole due to a Candida glabrata with decreased fluconazole-susceptibility and received micafungin for the entire duration of antifungal therapy). As previously reported, the study met its primary objective by confirming the once daily oral dose of SCY-078 750mg as a dose that is both overall safe and tolerated and achieves the target exposure in these patients. During the study period, there were no reports of mycological failures in the SCY-078 750mg group (n=7) versus two infection-related failures (one fungemia and one abdominal sepsis) in the fluconazole group (n=7). No relapses were observed in these two groups during the six-week follow-up period.
As previously reported, SCY-078 was overall safe and tolerated in both studies. There were no discontinuations due to adverse events (AEs) and no related serious AEs. Consistent with previous findings, the most common AEs were mild to moderate gastrointestinal (GI) events such as diarrhea nausea, vomiting, abdominal pain or discomfort. In patients with invasive candidiasis, the number of GI events were comparable in both the SCY-078 and fluconazole treatment arms.
"We achieved our stated goals and further de-risked the development of our lead product candidate, SCY-078," said Marco Taglietti, M.D., president and chief executive officer of Scynexis. “With these positive phase II data in hand, we believe SCY-078 is now the most advanced novel agent in a new antifungal class that can address the growing issue of resistance. We are also pleased to announce the infusion of additional funds from Solar Capital, providing us with the financial strength and flexibility to accelerate and expand the development of SCY-078 and to leverage our internal antifungal platform.”