PowerPoint Presentation


Angela Moore1,2, Lawrence J. Green3, Jodi L. Johnson4, Ayman Grada5
1Baylor University Medical Center, Dallas, Texas, USA, 2Arlington Research Center, Arlington, Texas, USA, 3Lawrence J. Green, MD, LLC, George Washington University School of Medicine, Washington, DC, USA 4Departments of Dermatology and Pathology, Feinberg School of Medicine, Northwestern 

University, USA, 5R&D and Medical Affairs, Almirall (US), Exton, Pennsylvania, USA  (Grada@bu.edu)

Introduction

Methods

Efficacy Safety

Conclusion 

Efficacy and Safety of Narrow-spectrum Oral Sarecycline for Moderate to Severe Acne Vulgaris

Co-primary Efficacy 
Endpoints

SC1401 SC1402

Placebo
N=485

Sarecycline
N=483

Difference (95% 
CI) 

[p-value]

Placebo
N=515

Sarecycline
N=519

Difference (95% 
CI) 

[p-value]

Change from baseline in 
inflammatory lesion count at 
Week 12, LS Mean (SE)

-10.1 (0.6) -15.3 (0.6)
-5.2 

(-6.7, -3.6) 
[<0.0001]

-10.7 (0.5) -15.1 (0.6)

-4.4 
(-5.8, -2.9)
[<0.0001]

IGA success at 
Week 12 10.5% 21.9%

11.05 
(6.39, 15.72)

[<0.0001]
15.3% 22.6%

7.30 
(2.53, 12.07)

[0.0038]

 Statistically significant reduction in mean absolute 
and percent inflammatory lesion count as early 
as week 3. IGA success rates were 21.9% and 
22.6% (sarecycline) versus 10.5% and 15.3% 
(placebo; P < .0001 and P = .0038)

 Statistically significant reduction in comedonal 
lesion count was observed at week 6 in SC1401, 
and at week 9 in SC1402 

Baseline Week 12

IGA score 4 1
Inflammatory lesions 50 4
Comedonal lesions 22 17

Baseline Week 12

IGA score 4 1
Inflammatory lesions 33 8
Comedonal lesions 33 5

Baseline Week 12

IGA score 3 0
Inflammatory lesions 21 0
Comedonal lesions 62 4

23 years-old female 19 years-old female 14 years-old male

TEAEs Common to 
Tetracycline-class

Antibiotics

SC1401 SC1402

Placebo (N=483) Sarecycline (N=481) Placebo (N=513)
Sarecycline 

(N=513)
Nasopharyngitis 8 (1.7%) 15 (3.1%) 15 (2.9%) 13 (2.5%)
Headache 13 (2.7%) 13 (2.7%) 25 (4.9%) 15 (2.9%)

Gastrointestinal adverse events 
Nausea 12 (2.5%) 22 (4.6%) 5 (1.0%) 10 (1.9%)
Vomiting 7 (1.4%) 10 (2.1%) 2 (0.4%) 3 (0.6%)
Diarrhea 8 (1.7%) 5 (1.0%) 6 (1.2%) 6 (1.2%)

Abdominal pain 6 (1.2%) 6 (1.2%) 1 (0.2%) 3 (0.6%)

Vestibular effects
Dizziness 7 (1.4%) 3 (0.6%) 4 (0.8%) 2 (0.4%)
Vertigo 0 0 0 0
Tinnitus 0 0 0 0

Phototoxic effects
Photosensitivity 0 0 0 1 (0.2%)
Sunburn 2 (0.4%) 3 (0.6%) 1 (0.2%) 4 (0.8%)

Vaginal yeast infections in females
Vulvovaginal 
candidiasis 0 3 (1.1%) 0 1 (0.3%)

Vulvovaginal 
mycotic infection 0 2 (0.7%) 0 3 (1.0%)

Moore A, Green LJ, Bruce S, et al. Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials. Journal of drugs in dermatology: JDD. 2018 Sep;17(9):987-96. Financial support provided by Almirall, LLC 

 Sarecycline is a narrow-spectrum tetracycline-class 
antibiotic designed  for the treatment of moderate-to-
severe acne. 

 Sarecycline’s narrow-spectrum anti-bacterial activity 
and lipophilicity may minimize side effects commonly 
associated with broad-spectrum tetracyclines, such as 
minocycline and doxycycline.

 Here, we report the results of 2 identically designed, 
phase 3 pivotal trials, SC1401 and SC1402, to 
evaluate the efficacy and safety of once-daily 
sarecycline (n=2002).

Males and females
Aged 9 to 45 years

Between 33 kg and 136 kg

Moderate to severe (IGA ≥ 3) facial acne 
20 – 50 Inflammatory Lesions

≤ 100 Noninflammatory Lesions
≤ 2 Nodules

Subjects randomized 1:1 to 
Sarecycline 1.5 mg/kg/day oral or 

Placebo

 Two phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel group 
studies

 Up to 35 day screening period to establish eligibility and  baseline
 12 week double-blind treatment with study visits at 3, 6, 9, and 12 weeks 

 Co-primary efficacy endpoints:  
 Absolute change in facial inflammatory lesion count at week 12
 IGA Success – IGA score of 0 (clear) or 1 (almost clear) and ≥ 2 point 

improvement from baseline
 Secondary efficacy endpoints included absolute and percent change from baseline in 

inflammatory and noninflammatory lesions at weeks 3, 6, 9 & 12. IGA success for 
truncal acne was reported as well

n=2002

 The same IGA scale was used for the chest and 
back assessments as for facial acne

 Back: Significant improvements at week 12 in 
SC1401 (-32.9 vs -17.1%; p < 0.001) and 
SC1402 (-33.2 vs -25.7%; p < 0.05).

 Chest: Significant improvements was seen at 
week 12in SC1401 (-29.5 vs -19.6%; p < 0.05) 
and SC1402 (-36.6 vs -21.6%; p < 0.001)

Facial Acne

Truncal Acne  (back and chest)

 The FDA-approved narrow-spectrum antibiotic 
sarecycline was safe, well-tolerated, and 
effective for moderate to severe inflammatory 
acne vulgaris in patients 9 years old and older

 Significant reduction in inflammatory lesions as early as 3 
weeks

 Significant improvement in truncal acne (chest and back) was 
reported  

 Significant improvement on comedonal acne was reported as 
well

 Incidence of side effects commonly associated 
with tetracycline-class antibiotics was low (<5%)

mailto:Grada@bu.edu

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