UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(D)
of the Securities Exchange Act of 1934
April 27, 2018
Date of report (Date of earliest event reported)
Agile Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
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001-36464 |
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23-2936302 |
(State or other jurisdiction |
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(Commission |
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(IRS Employer |
101 Poor Farm Road |
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08540 |
Registrants telephone number, including area code (609) 683-1880
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
Item 8.01. Other Events.
Agile Therapeutics, Inc. (Agile) a womens healthcare company, has had a poster presentation of additional results from the Phase 3 SECURE study of AG200-15 (Twirla®), an investigational, once weekly, low-dose hormonal contraceptive patch accepted at the 2018 Annual Clinical and Scientific Meeting of the American Congress of Obstetricans and Gynecologists (ACOG) being held April 27th through April 30th, 2018 in Austin, Texas. Dr. Anita Nelson, MD, Professor and Chair, Obstetrics and Gyencology at the College of Osteopathic Medicine of the Pacific, will present the poster titled The Patch Wear Profile from SECURE: A Once-Weekly Low Dose Contraceptive Patch Study, which includes data on the adhesion profile and wearability of AG200-15.
The SECURE clinical trial was designed to evaluate the efficacy, safety, and tolerability of AG200-15, also known as Twirla (levonorgestrel/ethinyl estradiol), in a representative population of women seeking birth control. SECURE was a 1-year, multicenter, single-arm, open-label trial in 2032 healthy women aged 18 and over, at 102 experienced investigative sites across the United States.
A copy of Agiles poster is attached hereto as Exhibit 99.1 and is hereby incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
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Description |
99.1 |
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Agile Therapeutics, Inc. Poster Presentation dated April 27-30, 2018. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Agile Therapeutics, Inc. | |
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Dated: April 27, 2018 |
By: |
/s/ Alfred Altomari |
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Name: |
Alfred Altomari |
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Title: |
Chairman and Chief Executive Officer |
The Patch Wear Profile From SECURE: A Once-Weekly Low-Dose Contraceptive Patch Study Anita L. Nelson1; Andrew M. Kaunitz2; Robin Kroll3; James A. Simon4; Paula M. Castaño5; Elizabeth I.O. Garner6 1Western University of Health Sciences, Pomona, CA; Professor Emeritus, David Geffen School of Medicine at UCLA, Los Angeles, CA; 2University of Florida College of Medicine-Jacksonville, Jacksonville, FL; 3University of Washington, Seattle, WA; 4George Washington University School of Medicine, Washington, DC; 5Columbia University Irving Medical Center, New York, NY; 6Agile Therapeutics, Princeton, NJ. Figure 2. Five-Point Adhesion Assessment Scale (Not drawn to scale) For Cycles 1-13 combined, the participant-reported mean skin irritation score was 1.31 Participant-reported mean skin irritation scores by cycle were low and generally decreased over time (Figure 3) For Cycles 1-13 combined, using the worst irritation score for each participant, the investigator-assessed mean skin irritation score was 0.18 Investigator-assessed mean skin irritation scores by cycle were low (Figure 3) Table 3. Investigator-Rated Patch Adhesion Over the 7-Day Wear Period AG200-15 (Twirla®) A transdermal contraceptive delivery system (TCDS) under investigation as a once-weekly prescription contraceptive patch (Figure 1) A 28-day cycle includes: 3 weeks of 7-day patches and 1 patch-free week Figure 1. Schematic of AG200-15 TCDS: A Once-Weekly Contraceptive Patch (Not drawn to scale) 0 1 2 3 Figure 3. Mean Skin Irritation Scores by Cycle, as Reported by Participants and Assessed by Investigators 1 *Average is weighted mean to account for number of measurements for each patch wear day. 0: >90% adhered (none to minimal lift); 1: >75% adhered but <90% (some edge showing lift); 2: >50% adhered but <75% (at least half of system lifts off); 3: <50% (> half of system lifts off, but patch remains attached); 4: patch detached. Adverse Events/Discontinuations Across 13 cycles, 6.2% of participants reported a local site reaction Treatment discontinuation due to application site irritation/itching occurred in 1.9% of participants The overall participant discontinuation rate from the study was 51.3% Of participants who reported at least one patch detachment, 46.3% discontinued from the trial vs. 53.7% that completed Of participants who did not report a patch detachment, 61.0% discontinued from the trial vs. 39.0% that completed Delivers daily exposure of levonorgestrel (LNG) and ethinyl estradiol (EE) similar to oral doses of 120 g of LNG and 30 g of EE 0 1 2 3 4 5 6 Cycle 7 8 9 10 11 12 13 SECURE (Study to Evaluate Contraception Use, Reliability, and Effectiveness) Investigator assessments did not occur at every cycle. *Worst score during a cycle for each participant; 0: no skin irritation; 1: mild; 2: moderate; 3: severe. A 1-year, single-arm, open-label, multicenter phase 3 study of the contraceptive efficacy, safety, and tolerability of AG200-15 TCDS Broad enrollment criteria with no limits on body mass index (BMI) or weight Yielded a Pearl Index for participants age 18 to 35 years of 4.8 (upper bound of 95% confidence interval, 6.1), with an adverse event (AE) profile similar to approved combined hormonal contraceptives (Nelson et al., ACOG 2017, abstract #22A) Overall, 85.0% and 12.6% of participants were determined by the investigator to have none or mild skin irritation, respectively 14.6%, 29.1%, and 37.6% of participants reported their worst itching score as none, mild, or moderate, respectively Overall the mean participant-reported skin itching score was 1.6 2031 participants received at least one patch and were included in the safety analysis 93% of patch applications were scheduled, demonstrating that participants rarely required unscheduled patch changes (replacements) A decreasing trend in the percent of unscheduled patch changes (replacements) was observed from Cycle 1 to Cycle 13, showing improvement with increasing participant experience Overall, results of participant-and investigator-rated patch characteristics indicate favorable patch adhesion and wearability of the AG200-15 TCDS Rates of skin irritation were generally low The rate of local site reactions was low and treatment discontinuation due to application site irritation/itching occurred in <2% of participants Adhesion analysis across a 7-day period of patch wear suggests a favorable patch adhesion profile Patch detachments did not contribute to participants leaving the study early; participants reporting any detachments during the trial did not discontinue from the trial at a higher rate than those that did not report any patch detachments Adhesion Participant-reported patch adhesion: Across all patches over the 7-day wear period, the mean patch adhesion score was 0.16 (Table 2) When assessed by patch wear day, on average, 89.6% of patches had adhesion of >90% (scores of 0) The percent of patches per day that completely detached decreased from 2.1% to 0.7% Irritation/Itching Here we examine various aspects of patch adhesion and wearability with the AG200-15 TCDS Across all patches applied in each cycle, 77.6% of participants reported a 0 (none) in Cycle 1 and 86.5% reported a 0 in Cycle 13 for their worst skin irritation Overall, across all cycles and all patches applied, 93.6% of participants reported their worst skin irritation score as none or mild; only 1.5% reported their worst skin irritation score as severe (Table 1) Table 2. Participant-Reported Patch Adhesion Over the 7-Day Wear Period The SECURE trial was conducted in US women 18 years or older with no restriction on BMI or weight (ClinicalTrials.gov NCT02158572) Patch-related irritation/itching and patch adhesion were evaluated by the investigator at each visit and by the participants through an electronic diary Irritation scores were graded using a 4-point scale: 0 (None): No irritation or barely perceptible/spotty erythema 1 (Mild): Mild erythema covering most of the application site or the skin immediately surrounding the application site 2 (Moderate): Moderate erythema covering most of the application site or the skin immediately surrounding the application site, with or without presence of mild edema 3 (Severe/Significant): Severe erythema of the application site or the skin immediately surrounding the application site, with or without edema, vesiculation, bullae, and/or ulceration Itching scores were graded by participants using a 4-point scale: 0 (none), 1 (mild), 2 (moderate), and 3 (severe) Patch adhesion scores were rated by participants and investigators using a scale from 0 to 4 (Figure 2) AN: Consultant/Advisor: Agile, AMAG Pharma, Bayer, ContraMed, Merck, Pharmanest; Honoraria/ Speaker: Allergan, Bayer, Merck; Grants/Research Support: Agile, ContraMed, Estetra SPRL, Evofem Inc, FHI (MonaLisa), Mathra Pharma, Merck. AK: Consultant/Advisor: Bayer, Merck, Mithra; Consultant (institution): Medicines360; Research Support (institution): Agile, Allergan, Bayer, Evofem, Merck, Mithra. RK: Research Support: AbbVie, Agile, Allergan, Bayer, Chemo Group, Contramed, Merck, Mithra. JS: Consultant/Advisor: AbbVie, Allergan, AMAG, Amgen, Ascend, Azure, Millendo, Nuelle, Radius, Regeneron, Roivant, Sanofi, Sebela, Sermonix, Shionogi, Symbiotec, TherapeuticsMD, Valeant; Speaker: Novo Nordisk, Shionogi, Valeant; Research Support: AbbVie, Agile, Allergan, Bayer, New England Research Institute, Palatin, Symbio, TherapeuticsMD; Stock Ownership: Sermonix. PC: Consultant/Advisor: Bayer; Research Support: Bayer. EG: Employee/Stock Ownership: Agile Therapeutics. Table 1. Participant-Reported Skin Irritation Score for Each Patch per Cycle and Overall *Average is weighted mean to account for no. of measurements for each patch wear day. 0: no lifting or small amount of lifting at edges of the patch; 1: more than a small amount of lifting at the edges up to one-quarter of the patch lifting off; 2: more than one-quarter of the patch lifting off up to half of the patch lifting off; 3: more than half of the patch is lifting off, but the patch is still on; 4: patch detached. Funding to support the development this poster was provided by Agile Therapeutics to MedVal Scientific Information Services, LLC, Princeton, NJ. Investigator-rated patch adhesion: Across all patches over the 7-day wear period, the mean patch adhesion score was 0.04 (Table 3) When assessed by patch wear day, on average, 96.9% of patches had adhesion of >90% (scores of 0) In total, 0.2% of patches were rated as completely detached *Worst score during a cycle or overall for each patch. 0: no skin irritation; 1: mild; 2: moderate; 3: severe. Presented at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting, April 27-30, 2018, Austin, TX Mean Skin Irritation Score* Acknowledgements Cycle Skin Irritation Score* (%) 0 77.6 1 2 3 1 16.1 5.3 1.0 2 79.7 13.4 5.3 1.6 3 81.2 11.7 5.3 1.7 4 80.7 12.4 5.2 1.7 5 83.6 9.9 4.9 1.6 6 83.2 10.2 5.1 1.4 7 83.9 10.3 4.5 1.3 8 83.6 10.3 4.3 1.8 9 84.8 9.6 4.4 1.2 10 84.2 9.2 5.1 1.5 11 84.2 9.8 4.4 1.6 12 85.5 8.5 4.5 1.5 13 86.5 8.8 3.7 1.0 Overall 82.4 11.2 4.9 1.5 Patch Wear Day % of Patches with Relevant Adhesion Score Mean Daily Adhesion Score 0 1 2 3 4 1 90.2 5.6 1.3 0.8 2.1 0.19 2 95.7 3.0 0.4 0.2 0.7 0.07 3 93.2 5.3 0.7 0.3 0.5 0.10 4 90.2 7.2 1.2 0.5 0.8 0.15 5 87.4 9.4 1.6 0.7 0.8 0.18 6 84.9 11.1 2.2 1.0 0.8 0.22 7 82.8 12.7 2.6 1.4 0.7 0.24 *Average 89.6 7.4 1.4 0.7 1.0 0.16 Disclosures Methods Objective Conclusion/Implications Results Modified Scale Language for Score Investigators Participants 0 >90% adhered (none to minimal lift) No lifting or small amount of lifting at the edges of the patch 1 >75% adhered but <90% (some edges showing lift) More than a small amount of lifting at the edges up to one-quarter of the patch lifting off 2 >50% adhered but <75% (at least half of system lifts off) More than one-quarter of the patch lifting off up to half of the patch lifting off 3 <50% (more than half of the patch lifts off, but the patch remains attached) More than half of the patch is lifting off, but the patch is still on 4 Patch completely detached Patch has completely come off AG200-15 Dimensions Total Patch Area 28.0 cm2 Active Drug Matrix Area 15.0 cm2 Total Patch Diameter 5.97 cm Drug Matrix Diameter 4.37 cm Peripheral Adhesive Width 0.80 cm Total Patch Thickness <1 mm Participant-reported Investigator-asssessed Active Drug-Free Matrix Periphery Patch Wear Day % of Patches with Relevant Adhesion Score Mean Daily Adhesion Score 0 1 2 3 4 1 98.0 1.6 0.1 0 0.2 0.03 2 97.4 2.0 0.4 0.1 0.2 0.04 3 96.1 3.6 0.2 0 0.2 0.05 4 94.6 4.6 0.5 0.2 0.2 0.07 5 92.9 6.7 0.2 0 0.2 0.08 6 94.4 5.0 0.6 0 0 0.06 7 95.1 4.5 0.4 0 0 0.05 *All Days 96.9 2.7 0.2 0 0.2 0.04 Introduction