PRINCETON, N.J.—In hopes of advancing its pipeline of contraceptive options, Agile Therapeutics Inc. is preparing for an initial Phase 2 clinical trial of a novel contraceptive regimen, expanding its pipeline beyond Twirla, the company’s lead candidate.
As noted on Agile’s website, “Twirla is a combined hormonal contraceptive, or CHC, patch that contains the active ingredients ethinyl estradiol, or EE, which is a synthetic estrogen, and levonorgestrel, or LNG, which is a type of progestin, a synthetic steroid hormone.” The once-weekly prescription contraceptive patch uses the company’s proprietary transdermal Skinfusion technology and delivers hormones over the course of seven days “at levels comparable to currently marketed low-dose oral contraceptives.”
“Expanding our pipeline is a key element of our strategic plan,” Al Altomari, president and CEO of Agile, noted in a press release. “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.”
The plan is for 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,” Agile noted in a press release. Specifically, it is hoped that this regimen will offer women shorter, lighter periods, which research suggests is a highly desirable trait for women pursuing hormonal contraception.
The study will seek to determine the optimal dose of the SmP, while monitoring bleeding profiles, pharmacokinetic parameters, ovulation inhibition and safety over the course of three treatment cycles. The goal is to enroll up to 150 women at sites that are also taking part in the ongoing Phase 3 SECURE trial, with dosing expected to begin in the first quarter of next year. Beyond this work, Agile is also looking into developing an extended cycle regimen for Twirla using the SmP that could result in women having fewer periods annually.
“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,” remarked Dr. Elizabeth Garner, 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.”
Hormonal contraceptives work by manipulating the body’s levels of estrogen, progesterone or both. Contraceptives usually feature progestin, a form of progesterone that, together with estrogen, can interrupt ovulation, decrease menstrual flow and/or impede egg fertilization by thickening cervical mucus.
Shortly after this announcement, Agile also reported its financial results for the second quarter of 2016. The company reported cash and cash equivalents of $59.2 million as of June 30, which Agile expects will be sufficient for operating requirements through the end of next year. Research R&D expenses were down from $6.2 million in Q2 2015 to $5.6 million in this past quarter. In contrast, general and administrative expenses were up slightly from $1.8 million to $2.3 million, which was largely attributed to increased stock-based compensation expense associated with 2016 stock option grants. Agile recorded a net loss of $8.4 million, or 29 cents per basic share, for the quarter, a slight drop from the net loss of $8.5 million, or 38 cents per basic share, reported for the same quarter in 2015.