Agile Therapeutics, Inc. Reports Third Quarter 2016 Financial Results And Announces Completion Of Subject Visits For Twirla Phase III SECURE Clinical Trial
PRINCETON, N.J., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty pharmaceutical company, today announced completion of all final subject visits for its Twirla® Phase 3 SECURE clinical trial, reported financial results for the three and nine months ended September 30, 2016, and provided a corporate update for the third quarter 2016.
“Completion of all subject visits in our SECURE clinical trial is a significant milestone in the development of Twirla,” said Elizabeth Garner, M.D., M.P.H., Chief Medical Officer of Agile. “We can now move forward with data verification and database lock activities, which we anticipate being completed by the end of December 2016. We will then proceed with initial data analysis and expect to announce top-line data in early January 2017. We believe we have conducted a well-run trial focused on quality and the key metrics the U.S. Food and Drug Administration (FDA) has indicated would be most important in their assessment of SECURE. We look forward to submitting a comprehensive package of reliable data that we believe can respond to the FDA’s questions as well as establish the safety and efficacy profile for Twirla. We would like to thank our investigators and their staff, our partners and, most importantly, the women who participated in SECURE for helping us conduct such a rigorous study.”
“Completion of all subject visits in our SECURE clinical trial is a significant milestone in the development of Twirla,” said Elizabeth Garner, M.D., M.P.H., Chief Medical Officer of Agile. “We can now move forward with data verification and database lock activities, which we anticipate being completed by the end of December 2016. We will then proceed with initial data analysis and expect to announce top-line data in early January 2017. We believe we have conducted a well-run trial focused on quality and the key metrics the U.S. Food and Drug Administration (FDA) has indicated would be most important in their assessment of SECURE. We look forward to submitting a comprehensive package of reliable data that we believe can respond to the FDA’s questions as well as establish the safety and efficacy profile for Twirla. We would like to thank our investigators and their staff, our partners and, most importantly, the women who participated in SECURE for helping us conduct such a rigorous study.”