Agile Therapeutics, Inc., a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, announced that preparations are underway for an initial phase 2 clinical trial of a novel contraceptive regimen, which will begin the development of its pipeline beyond its current lead product candidate, Twirla, a once weekly contraceptive patch currently in phase 3 development. The planned phase 2 clinical trial will examine the use of Twirla in an innovative regimen designed to allow women to experience shorter, lighter periods.

“Today marks an important step for Agile as we begin to execute our strategic plan to develop our pipeline of new product candidates based on Twirla,” said Elizabeth Garner, M.D., M.P.H., chief medical officer of Agile. “Agile’s pipeline is designed to build on our current patch regimen and offer women additional, convenient non-daily contraceptive options that provide flexibility to meet their needs.”

Agile plans to conduct an initial phase 2 study of a novel 28-day contraceptive patch regimen (AG200-SP) designed to optimize the bleeding profile by delivering hormones beyond the typical 21 day regimen using a smaller lower dose combination ethinyl estradiol/levonorgestrel patch (SmP) in the fourth week of the cycle. The SmP regimen is intended to allow women to experience shorter, lighter periods, an attribute that research suggests is highly desirable to women seeking hormonal contraception. The planned study is aimed at identifying the optimal dose of the SmP, and will evaluate bleeding profiles, pharmacokinetic parameters, ovulation inhibition and safety over 3 cycles of treatment. Up to 150 subjects are expected to be enrolled at highly experienced sites that are also participating in the ongoing phase 3 SECURE clinical trial. The company has started preparations for the study and expects to initiate dosing in the first quarter of 2017. Agile also plans to develop an extended cycle regimen for Twirla (AG200-ER) that may also utilize the SmP with the goal of allowing women to have fewer periods each year.

“Expanding our pipeline is a key element of our strategic plan,” said Al Altomari, chief executive officer and president of Agile. “Based on patent protection expected to extend into 2029, we believe we are in a strong position to build a women’s health franchise that will enable us to be commercially competitive and expand our market potential.”