Clinical Data A Phase 2, multi-center, randomized, double-blind study has been conducted by Toyama to evaluate the efficacy, safety and pharmacokinetics of solithromycin in Japanese patients. Patients with mild to moderate community-acquired pneumonia (CABP) were randomized at a 2:1 ratio to either oral solithromycin or oral levofloxacin for 5 days. Solithromycin recipients received 800 mg on the first day, either as a single dose (QD group), or as a divided dose (BID group), and 400 mg daily on Days 2-5. Levofloxacin recipients received 500 mg once daily on Days 1-5. The Japanese study was similar in design to the Phase 3 studies conducted by Cempra in CABP in accordance with guidance from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).Efficacy 
Among 154 enrolled and randomized patients, 135 received at least one dose of study medication, and were confirmed by independent expert physician review to have CABP (the modified ITT population). In the modified ITT population, Test of Cure visit (5-10 days after completion of therapy) success was achieved in 34/44 (77.3%), 32/44 (72.7%), and 29/47 (61.7%) patients in the solithromycin QD and BID and Levofloxacin groups, respectively. In the pre-specified Per Protocol population comprised of those patients meeting key study inclusion and exclusion criteria, success at the Test of Cure visit was achieved in 34/40 (85.0%) in the solithromycin QD group, versus 31/40 (77.5%) in the solithromycin BID group, and 29/43 (67.4%) in the Levofloxacin group. Safety 
Overall safety and tolerability was similar in both treatment groups, including hepatic events such as increases in alanine aminotransferase (ALT).