Efficacy of a Novel Formulation of Betamethasone Dipropionate 0.05% Spray Versus Augmented Betamethasone Dipropionate 0.05% Lotion in Patients ≥ 18 Years of Age with Moderate Plaque Psoriasis: A Pooled Analysis All other trademarks are property of their respective owners. All rights reserved. OBJECTIVE METHODS RESULTS INTRODUCTION ©2023 Primus Pharmaceuticals, Inc. Scottsdale, AZ 85253 To further assess the efficacy of BDS versus BDL in patients with moderate plaque psoriasis using pooled data from two Phase 3 clinical trials. Pooled efficacy analysis included patients with stable disease (present for ≥ 3 months), an Investigator Global Assessment (IGA) = 3, and a Body Surface Area (BSA) of 10-20% who received either BDS (N = 356) or BDL (N = 90). Efficacy included the proportion of patients with success defined as an IGA = 0 or 1 (none or minimal) and ≥ 2-grade improvement at day 15; the proportion of patients with a TSS50 (Total Sign Score improvement of at least 50%); the proportion of patients with a TSS = 0 or 1 (clear or slight to mild) stratified by sign; and the relative proportion of patients receiving BDS (within group) with a TSS = 0 or 1 stratified by sign. Statistical analysis included a Fisher’s Exact (2-tail) test for categorical data. Success based on IGA was greater for BDS versus BDL at days 4 (2.2% versus 1.1%, P = 0.6941), 8 (11.5% versus 6.7%, P = 0.2480), and 15 (20.2% versus 18.9%, P = 0.8829), but not statistically significant. The proportion of patients with a TSS50 was greater for BDS at days 4 (13.2% versus 5.6%, P = 0.0438), 8 (34.7% versus 29.2%, P = 0.3789), and 15 (51.0% versus 42.0%, P = 0.1523) with statistical significance at day 4. The proportion of patients with a TSS = 0 or 1 stratified by sign is presented in Table 1. Statistically significant superiority was observed in patients receiving BDS versus BDL for erythema at day 4, and scaling at days 4 and 15. Within group (BDS) comparisons for each TSS sign are presented in Table 2. The proportion of patients with a TSS = 0 or 1 was statistically greater for scaling versus erythema and plaque elevation at all time points. Success was similar between a novel mid-potent formulation of betamethasone dipropionate 0.05% spray (BDS) and super-high potency augmented betamethasone dipropionate 0.05% lotion (BDL). Patients receiving BDS achieved greater treatment efficacy regarding scaling than those receiving BDL. BDS was most successful within group in the treatment of scaling versus erythema and plaque elevation. Study 1 NCT 01947491 N=394 Randomized 4:2:2:1 Study 2 NCT 01967069 N=277 Randomized 2:1 BDS N=174 BDL N=90 Vehicle Spray N=87 Vehicle Lotion N=43 BDS N=182 Vehicle Spray N=95 Figure 1. Trial Designs REFERENCES: 1. Kircik L, Okumu F, Kandavilli S, Sugarman J. Rational Vehicle Design Ensures Targeted Cutaneous Steroid Delivery. J Clin Aesthetic Dermatol. 2017;10(2):12-19. 2. Fowler JF, Hebert AA, Sugarman J. DFD-01, a Novel Medium Potency Betamethasone Dipropionate 0.05% Emollient Spray,Demonstrates Similar Efficacy to Augmented Betamethasone Dipropionate 0.05% Lotion for the Treatment of Moderate Plaque Psoriasis. J Drugs Dermatol JDD. 2016;15(2):154-162. 3. Sidgiddi S, Pakunlu RI, Allenby K. Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis. J Clin Aesthetic Dermatol. 2018;11(4):14-22. 4. Stein Gold L, Jackson JM, Knuckles MLF, Weiss JS. Improvement in Extensive Moderate Plaque Psoriasis With a Novel Emollient Spray Formulation of Betamethasone Dipropionate 0.05. J Drugs Dermatol JDD. 2016;15(3):334-342. CONCLUSIONS Linda Stein Gold MD Jonathan S. Weiss MD Joseph F. Fowler MD Adelaide A. Hebert MD Jeffrey Sugarman MD Henry Ford Health System, Detroit, MI Geogia Dermatology Partners and Gwinnett Clinical Research Center, Inc., Snellville, GA University of Louisville, Louisville, KY UTHealth McGovern Medical School, Houston, TX Redwood Dermatology Research, Santa Rosa, CA This submission was supported by Primus Pharmaceuticals. Sign Day 4 Day 8 Day 15 Erythema Scaling Plaque Elevation Success (0 or 1) Success (0 or 1) Success (0 or 1) 84/356 (23.6%) 141/356 (39.6%) 99/356 (27.8%) 169/346 (48.8%) 213/346 (61.6%) 177/346 (51.2%) 214/347 (61.7%) 254/347 (73.2%) 228/347 (65.7%) Scaling vs Erythema Erythema vs Plaque Elevation Scaling vs Plaque Elevation p-value[a] p-value[a] p-value[a] < 0.0001 0.2298 0.0011 0.0010 0.5946 0.0073 0.0016 0.3048 0.0392 Table 2. BDS Within Group: A Pooled Analysis of Sign Scores (ITT Population) [a] P-values derived from Fisher's Exact (2-tail) test. Executed on 30DEC22:13:06; SAS (v9.4) Success Table 1. BDS versus BDL: A Pooled Analysis of Sign Scores (ITT Population) Sign Study Day Success/Failure BDS BDL p-value[a] Erythema Baseline Day 4 Day 8 Day 15 [a] P-values derived from Fisher's Exact (2-tail) test. Executed on 30DEC22:13:06; SAS (v9.4) Success (0 or 1) Failure Success (0 or 1) Failure Success (0 or 1) Failure Success (0 or 1) Failure 8/356 (2.2%) 348/356 (97.8%) 84/356 (23.6%) 272/356 (76.4%) 169/346 (48.8%) 177/346 (51.2%) 214/347 (61.7%) 133/347 (38.3%) 1/90 (1.1%) 89/90 (98.9%) 11/90 (12.2%) 79/90 (87.8%) 34/89 (38.2%) 55/89 (61.8%) 48/88 (54.5%) 40/88 (45.5%) 0.6941 0.0206 0.0754 0.2255 Scaling Baseline Day 4 Day 8 Day 15 Success (0 or 1) Failure Success (0 or 1) Failure Success (0 or 1) Failure Success (0 or 1) Failure 12/356 (3.4%) 344/356 (96.6%) 141/356 (39.6%) 215/356 (60.4%) 213/346 (61.6%) 133/346 (38.4%) 254/347 (73.2%) 93/347 (26.8%) 3/90 (3.3%) 87/90 (96.7%) 23/90 (25.6%) 67/90 (74.4%) 51/89 (57.3%) 38/89 (42.7%) 54/88 (61.4%) 34/88 (38.6%) 1.0000 0.0144 0.4680 0.0355 Plaque Elevation Baseline Day 4 Day 8 Day 15 Success (0 or 1) Failure Success (0 or 1) Failure Success (0 or 1) Failure Success (0 or 1) Failure 18/356 (5.1%) 338/356 (94.9%) 99/356 (27.8%) 257/356 (72.2%) 177/346 (51.2%) 169/346 (48.8%) 228/347 (65.7%) 119/347 (34.3%) 2/90 (2.2%) 88/90 (97.8%) 19/90 (21.1%) 71/90 (78.9%) 43/89 (48.3%) 46/89 (51.7%) 51/88 (58.0%) 37/88 (42.0%) 0.3915 0.2294 0.6369 0.2131 Betamethasone dipropionate 0.05% spray (BDS - Sernivo®, Primus Pharmaceuticals) is a novel mid-potent formulation indicated for the treatment of plaque psoriasis. In vitro testing has proven greater residence time for BDS within the skin compared to super-high potency augmented betamethasone dipropionate 0.05% lotion (BDL - Diprolene®, Organon). 1 In two identically designed Phase 3 trials, BDS showed statistically significant superiority over vehicle in both studies, and equivalence to BDL in Study 1 in terms of treatment success. 2-4 Data from these two Phase 3 trials have been pooled to further evaluate the effectiveness of BDS versus BDL. DISCLOSURES: LSG Investigator, Advisor, and/or Speaker for Arcutis, Dermavant, Leo, Ortho Derm, Pfizer, Primus Pharmaceuticals JSW Research Grants: Almirall, Dr. Reddy’s Lab, Galderma, Ortho, Promius Consulting: Cutera, Dr. Reddy’s Lab, EPI Health, Galderma, Novan, Ortho, Promius Advisory Boards: Dr. Reddy’s Lab, Galderma, Ortho, Promius JFF Consultant for Primus Pharmaceuticals; Speaker and Consultant for SmartPractice, Inc. AAH Research Grants (paid to the medical school): Pfizer, Arcutis, Abbvie, Leo, Xencor Honoraria (advisory boards and lectures): Pfizer, Arcutis, Leo, Ortho Dermatologics, Incyte, Almirall DSMB: Ortho Dermatologics, GSK, Regeneron, Sanofi JS Consulting: Galderma, Incyte, Sol-Gel Advisory Boards: Incyte, Pfizer, Sol-Gel Speaker: Galderma, Incyte, Pfizer Honoraria: Galderma, Incyte, Sol-Gel