By David Bautz, PhD
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Comparative Adhesion Study Underway
On January 10, 2018, Agile Therapeutics, Inc. (AGRX) announced receipt of the official meeting minutes from its Dec. 11, 2018 meeting with the U.S. Food and Drug Administration (FDA) Division of Bone, Reproductive and Urological Products (DBRUP). The meeting was held to discuss the company’s comparative wear study between Twirla® and Xulane®, the generic version of the contraceptive patch Ortho Evra®, including the specific design and success criteria. The trial is designed to show non-inferiority in adhesion between Twirla® and Xulane®. Following receipt of the official meeting minutes, Agile has initiated the adhesion study in approximately 80 healthy women with a body mass index (BMI) <35 kg/m2. Study subjects will wear either Twirla® or Xulane® for one week and then switch to the other patch for the second week. Adhesion of each patch will be quantified daily. Quantification of adhesion will be assessed through the following scale, which assigns a score based on the adhered surface area:
0 = ≥ 90% adhered (essentially no lift off the skin)
1 = ≥ 75% to < 90% adhered (only some edges lift off the skin)
2 = ≥ 50% to < 75% adhered (less than half is lifted off the skin
3 = > 0% to < 50% adhered (not detached, but more than half lifts off the skin)
4 = 0% adhered (detached and completely off the skin)
The primary endpoint of the study will be the mean adhesion score. We anticipate the study completing in the first quarter of 2019.
Assuming the comparative adhesion study completes in the first quarter of 2019, we believe Agile will be able to resubmit the NDA for Twirla® in the second quarter of 2019. We anticipate an Advisory Committee (“AdComm”) taking place to discuss the Pearl Index values from the Phase 3 trial. In addition, we anticipate an inspection of the third-party manufacturer’s facility taking place prior to approval. If the NDA is submitted in the first half of 2019, with a six-month review period Twirla® could be approved before the end of 2019.
We are glad to see that Agile has initiated the comparative wear study and we look forward to the results later in the first quarter of 2019. The study design is straight forward and we are confident that the trial will be a success. We currently estimate that the company has sufficient capital to fund operations through the second quarter of 2019 (which includes completion of the adhesion study), but will require additional capital to fund operations beyond that, including any pre-commercialization activities and the commercial launch of Twirla®, if approved. Our current valuation is $2.50.
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By David Bautz, PhD