20201210_Twyneo Age Analysis 0% 10% 20% 30% P er ce nt o f pa tie nt s ac hi ev in g IG A su cc es s at W ee k 12 MICROENCAPSULATED BENZOYL PEROXIDE 3%, MICROENCAPSULATED TRETINOIN 0.1% CREAM: EFFICACY FOR PEDIATRIC AND ADOLESCENT PATIENTS Stein Gold, L¹, Del Rosso, J² 1. Henry Ford Health Systems, Detriot, MI 2. JDR Dermatology Research, Las Vegas, NV INTRODUCTION • Benzoyl peroxide (BPO) is recommended for treatment of acne of all severities.1 It is bactericidal against C. acnes on the skin and within hair follicles with no risk for development of resistance,1,2 and it also has mild keratolytic effects.3 • BPO is widely used as a single agent in many different vehicles,4 and in combination with other medications.3,5 Multiple analyses have indicated that the efficacy of BPO is enhanced when used in combination with topical retinoids, such as tretinoin.6,7 However, BPO usually causes degradation of tretinoin, reducing its effectiveness.8 RESULTS Achievement of IGA Success • The efficacy of E-BPO/E-ATRA in pediatric and adolescent patients (9-17 years of age) was at least equivalent to that for the entire population. • E-BPO/E-ATRA is an investigational, antibiotic-free, fixed-dose combination cream containing microencapsulated BPO 3% (E-BPO) and microencapsulated tretinoin 0.1% (E-ATRA). The use of Sol-Gel’s microencapsulation technology platform provides a stable combination of BPO and tretinoin, extending drug delivery time, and reducing potential irritation caused by direct application of the drugs to the skin. • The efficacy, safety, and tolerability of E-BPO/E-ATRA have been demonstrated in two phase 3 randomized, vehicle-controlled trials.9 This result provides an analysis of the effectives of E-BPO/E-ATRA in patients of different ages based on analysis of results from those two studies, with a focus on pediatric and adolescent patients. • Pooled results from the two phase 3 trials of E-BPO/E-ATRA demonstrated that this new microencapsulated formulation of BPO and tretinoin was efficacious in pediatric and adolescent patients who comprise a very large segment of the overall population with acne and about 45% of the patients in the phase 3 trials. CONCLUSIONS • E-BPO/E-ATRA cream, combines, for the first time, two of the safest and most effective topical agents available for the treatment of acne into a single application. ACKNOWLEDGMENTS: The authors wish to recognize the support of Robert Rhoades, PhD, and Thomas Prunty, CMPP, of AraMed Strategies, LLC., for their editorial and scientific analysis support. Their assistance was funded along with the studies represented herein, bySol-Gel Technologies, Ltd. REFERENCES: 1. Zaenglein AL, et al. J Am Acad Dermatol. 2016;74:945-973 e933; 2. Walsh TR, et al. Lancet Infect Dis. 2016;16:e23-33; 3. Matin T, Goodman MB. 2019. Available from http://www.ncbi.nlm.nih.gov/books/ NBK537220/; 4. Kawashima M, et al. J Dermatol. 2017;44:1212-1218; 5. Kircik LH. J Drugs Dermatol. 2013;12:s73-76; 6. Sagransky M, et al. Expert Opin Pharmacother. 2009;10:2555-2562; 7. Fakhouri T, et al. J Drugs Dermatol. 2009;8:657-661; 8. Martin B, et al. Br J Dermatol. 1998;139 (Suppl 52):8-11; 9. Del Rosso J, et al. Presented at Maui Derm. 2020. To interact with and explore these data more intimately, please click here: https://www.solgelposters.com METHODS Design Reduction in Inflammatory Lesions • The efficacy of E-BPO/E-ATRA in pediatric and adolescent patients (9-17 years of age) was at least equivalent to that for the entire population. Reduction in Non-inflammatory Lesions • The efficacy of E-BPO/E-ATRA in pediatric and adolescent patients (9-17 years of age) was at least equivalent to that for the entire population. 2x trials / 12 weeks / 63 sites acrossUS • Two multicenter, randomized, double-blind, parallel-group vehicle-controlled trials (SGT-65-04 and SGT-65-05) carried out at 63 sites across the United States (Figure 1). Figure 1. Study design • Age ≥9 years • ≥20 to ≤100 Inflammatory lesions • ≥30 to ≤150 Non-inflammatory lesions • IGA grade 3 (Moderate) or grade 4 (Severe) • Cysts/nodules ≤2 In cl us io n cr ite ri a Randomization Baseline 2 4 Weeks 8 12 12 weeks of treatment 63 Total Sites Study 65 04: 424 Study 65-05: 434 QD, Self-applied Vehicle cream E-BPO/E-ATRA cream (3% E-BPO, 0.1% E-ATRA) 2:1 E-ATRA, microencapsulated tretinoin; E-BPO, microencapsulated benzoyl peroxide; IGA, Investigator’s Global Assessment; QD, once daily. Endpoints • Co-Primary Efficacy Endpoints ▪ Proportion of patients who achieved a two-grade reduction from baseline and grade 0 (Clear) or grade 1 (Almost Clear) at Week 12 on a 5-point IGA scale. ▪ Absolute change in inflammatory lesion counts from baseline at Week 12. ▪ Absolute change in non-inflammatory lesion counts from baseline at Week 12. Data Analysis • All efficacy analyses were carried out using the intent-to-treat population. Safety analyses were carried out using the safety population. • All results are reported as effects of E-BPO/E-ATRA vs vehicle (point estimates of the difference between treatments). IGA treatment success at week 12 40% M ea n re du ct io n in in fla m m at or y le si on c ou nt fr om b as el in e at W ee k1 2 Absolute mean change from baseline in inflammatory lesions at week 12 33.3% 14.9% 32.2% 34.2% 18.1% 10.6% -18.9 -14.3 -19.1 -18.8 -15.5 -12.8 Age: 0 -2 -4 -6 -8 -10 -12 -14 -16 -18 -20 Absolute mean change from baseline in non-inflammatory lesions at week 12 E-BPO/ Vehicle E-ATRA (n=287) (n=571) Age: E-BPO/ Vehicle E-ATRA (n=124) (n=264) E-BPO/ E-ATRA (n=307) All P<0.0001 ≥18 P=0.0002 All 9-17 ≥18 Vehicle (n=163) M ea n re du ct io n in in fla m m at or y le si on c ou nt fr om b as el in e at W ee k1 2 -27.2 -18.5 -28.9 -25.8 -21.1 -15.1 Age: 0 -3 -6 -9 -12 -15 -18 -21 -24 -27 -30 All 9-17 ≥189-17 P<0.0001 E-BPO/ E-ATRA (n=571) Vehicle (n=287) P<0.0001 E-BPO/ E-ATRA (n=264) Vehicle (n=124) E-BPO/ E-ATRA (n=307) Vehicle (n=163) P<0.0001 P=0.0055 E-BPO/ E-ATRA (n=571) Vehicle (n=287) P<0.0001 P<0.0001 E-BPO/ E-ATRA (n=264) Vehicle (n=124) E-BPO/ E-ATRA (n=307) Vehicle (n=163) P=0.0013 http://www.ncbi.nlm.nih.gov/books/ MICROENCAPSULATED BENZOYL PEROXIDE 3%, MICROENCAPSULATED TRETINOIN 0.1% CREAM: EFFICACY FOR PEDIATRIC AND ADOLESCENT PATIENTS