Profile: Agile Therapeutics Inc (AGRX.A)
22 May 2019
Agile Therapeutics, Inc., incorporated on December 5, 1997, is a women's health specialty pharmaceutical company. The Company is focused on the development and commercialization of prescription contraceptive products. Its product candidates are designed to provide women with contraceptive options. The Company has developed a transdermal patch technology, called Skinfusion. The Company's lead product candidate is Twirla, also known as AG200-15. In addition to Twirla, the Company is developing a pipeline of other new transdermal contraceptive products, including AG200-ER, which is a regimen designed to allow a woman to extend the length of her cycle; AG200-SP, which is a regimen designed to provide a shortened hormone-free interval, and AG890, which is a progestin-only contraceptive patch. Each of its product candidates utilizes its Skinfusion technology designed to deliver contraceptive-levels of hormones to the blood stream through the skin over a seven-day period.
The Company's product candidate, Twirla, is a combined hormonal contraceptive (CHC) patch that contains the active ingredients ethinyl estradiol (EE), which is a synthetic estrogen, and levonorgestrel (LNG), which is a type of progestin (a synthetic steroid hormone). The Twirla transdermal patch is applied once weekly for three weeks, followed by a week without a patch. Twirla uses a 28-day contraceptive regimen, where one patch is applied weekly for three consecutive weeks and then there is a fourth patch-free week in each 28-day time period. The Company is conducting the third Phase III study of Twirla.
The Company's product candidate, AG200-ER is an extended cycle regimen utilizing the Company's patch product designed to allow a woman to extend the time between her episodes of withdrawal bleeding. By adjusting the length of the cycle, AG200-ER is designed to minimize bleeding and spotting. AG200-ER contains ethinyl estradiol and LNG as active ingredients. The Company is evaluating the optimal cycle length to advance into Phase III clinical development.
The Company's product candidate, AG200-SP is a 28-day regimen designed to provide users with shorter, lighter withdrawal bleeds. AG200-SP is designed to provide a simplified 28-day regimen through use of a smaller, lower-dose patch in the fourth week. AG200-SP may also provide benefit in patients with sensitivity to abrupt changes in hormone levels.
The Company's product candidate, AG890 is a LNG-only contraceptive patch, intended for use by women unable or unwilling to take estrogen, including breastfeeding ones or the ones at risk of venous thromboembolism (VTE), such as women smokers; the ones over 35 years of age, or obese women. The Company conducted a Phase I clinical trial with AG890. In addition, the National Institutes of Health, through a clinical trial agreement with the Company, has conducted a Phase I/II trial with AG890. The Phase I/II study was a multicenter study to evaluate the pharmacokinetics, safety and mechanisms of potential contraceptive efficacy of AG890.
Agile Therapeutics Inc
101 Poor Farm Rd
PRINCETON NJ 08540-1941