UPDATE: Agile Initiates Phase 3 SECURE Study for Twirla

Agile Therapeutics, Inc.,

a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, today announced the initiation of its Phase 3 study called SECURE (Study to Evaluate Contraceptive Use, Reliability and Effectiveness). The SECURE study is designed to assess the efficacy, safety and tolerability of Agile's investigational once-weekly transdermal contraceptive patch, Twirla™ (AG200-15). Twirla will be the only low-dose combined hormonal contraceptive patch and delivers the active ingredients ethinyl estradiol and levonorgestrel, both of which have an established history of efficacy and safety in currently marketed combination low-dose oral contraceptives. "In planning the SECURE study, we focused on identifying experienced clinical sites with expertise in conducting contraceptive studies, and leveraging technology to support patient compliance and retention in the trial," said Elizabeth Garner, M.D., M.P.H., and Chief Medical Officer at Agile. "We believe we have the right measures in place to achieve our goal of making Twirla available to women as an effective and convenient contraceptive option." The SECURE study is a single-arm, open-label, multicenter Phase 3 study of Twirla (AG200-15) that will enroll approximately 2,100 female subjects who will use the patch for up to one year. The study will assess the effectiveness of the patch in preventing pregnancy using the Pearl Index as the primary contraceptive efficacy measure. Safety and tolerability will also be evaluated. "The initiation of the confirmatory SECURE clinical study continues to proceed as planned. We are pleased to report that screening of patients is underway at some of the sites and we have our first subjects in the study run-in period using the e-diary," said Al Altomari, Chief Executive Officer and President of Agile. "We continue to believe there is a significant opportunity to provide women with a more convenient contraceptive option that adapts to their busy lifestyles and we remain committed to execute on our goal to address this important unmet need." The Company continues to expect an enrollment period of four to six months. The results from the SECURE study are intended to support the Company's New Drug Application with the U.S. Food and Drug Administration for marketing approval of Twirla (AG200-15) in the United States. More information on the clinical trial is available at www.clinicaltrials.gov