Sb202

Results of a Phase 2 Efficacy and Safety Study with SB204, an Investigational Topical Nitric Oxide-releasing Drug for the Treatment of Acne Vulgaris

Primary objective
This study was conducted to study the safety, efficacy, and tolerability of two concentrations of SB204 (1% and 4%) in comparison with vehicle used for the treatment of subjects with acne vulgaris. The subjects applied the topical treatment twice-daily for 12 weeks.

Methodology
Study Design
This study was a Phase 2 clinical trial conducted in multiple centers in Latin America. It is a double-blind, vehicle-controlled, three-arm study and subjects were randomized 1:1:1 into one of the three treatment arms – Vehicle, SB204 1% and SB204 4%. The dosage of the topical gel was 900mg and subjects were to apply
The most common adverse events were nasopharyngitis in 6 subjects, headache in 11 subjects, and dysmenorrhea in 10 subjects (Table 2). The TEAEs that occurred during the study were not serious in nature and considered not related to the drug. No SAEs were reported during the study. Both concentrations of SB204 were safe and well-tolerated.

Table 2 Summary of most common adverse events by MedDRA System Organ Class Preferred Term occurring at a frequency ≥5% in any treatment group - Safety Analysis Set
System Organ Classa Preferred Term Vehicle (N = 52) SB204 1% (N=51) SB204 4% (N=50) Pooled SB204 (N=101)

Nasopharyngitis; n (%) 1 (1.9%) 3(5.9%) 2 (4.0%) 5 (5.0%)

Headache; n (%) 5 (9.6%) 1 (2.0%) 5 (10.0%) 6 (5.9%)

Dysmenorrhea; n (%) 4 (7.7%) 3 (5.9%) 3 (6.0%)