Phase 3 VANISH-306 Trial Results – What’s up?
SCYX announced on 23rd November 2021 that the results of its Phase 3 VANISH-306 research have been peer-reviewed and published in the International Journal of Obstetrics and Gynecology (BJOG). Moreover, the VANISH-306 trial found that oral ibrexafungerp therapy was better than placebo on major study endpoints with a significant level of statistical validity, as well as being relatively safe and well-tolerated.
The company thinks that the release of the data from VANISH-306 research will offer doctors critical information on the effectiveness and safety of this ground-breaking medicine as a potentially life-saving therapeutic option for millions of women throughout the country.
Third Quarter 2021 Results Disclosed – What’s new?
SCYX reported third-quarter 2021 results on 10th November 2021. The report says that BREXAFEMME produced $0.5 million in net product revenues, which was in line with internal expectations. Moreover, the cost of product revenues was $0.1 million. The cost of research and development for the three months came out to be $4.4 million.
Furthermore, the selling, general, and administrative expenditure grew to $15.4 million, $3.5 million more than the same period in 2020. Cash and cash equivalents were at $100.1 million, $93.0 million more than that of December 31, 2020. Lastly, SCYX believes that its existing cash and cash equivalents, the sale of a part of its New Jersey NOLs, and the expected sales of BREXAFEMME will enable the company to finance its operational requirements until 2023, based on its current operating plan.
Completion of Phase 1 Trial – Recent Updates by SCYX
SCYX reported the conclusion of Phase 1 clinical trial in healthy volunteers to assess the safety, tolerability, and pharmacokinetics of a liposomal intravenous (IV) formulation of ibrexafungerp on 9th November 2021. Experts conducted research on 64 healthy volunteers with treatment durations ranging from one to seven days. Moreover, Ibrexafungerp was well tolerated in its liposomal IV formulation, with no significant side effects noted. Mild (with a few moderate) responses at the infusion site were the most prevalent side effects.