Cempra Inc (NASDAQ:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, is jointly developing solithromycin for the Japanese market in partnership with Toyama Chemical, a subsidiary of FUJIFILM Holdings Corporation.

The Japanese market is the second largest antibiotic market in the world with a macrolide market potential of over $450 million.

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).

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.

Overall safety and tolerability was similar in both treatment groups, including hepatic events such as increases in alanine aminotransferase (ALT).

“I could not be happier to receive the results of this important study completed by our strong partner in Japan; the safety and efficacy outcomes further validate global Phase 3 trial data demonstrating the potential for solithromycin in the treatment of this serious infection,” stated Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. “The need for a new treatment for CABP in Japan is great as multidrug resistance to commonCABP pathogens such as Mycoplasma and Haemophilus continues to rise, with pneumococcal resistance to older macrolides reaching 88% in Japan. Solithromycin has once again demonstrated robust activity in comparison to a potent fluoroquinolone, levofloxacin, one of the most widely prescribed agents to treat CABP.” (Original Source)

Shares of Cempra are up nearly 4% to $18.12 in after-hours trading. CEMP has a 1-year high of $46.99 and a 1-year low of $14.03. The stock’s 50-day moving average is $17.15 and its 200-day moving average is $21.16.

On the ratings front, Cempra has been the subject of a number of recent research reports. In a report issued on May 9, Janney Montgomery Scott analyst Debjit Chattopadhyay maintained a Hold rating on CEMP, with a price target of $23, which represents a potential upside of 31.5% from where the stock is currently trading. Separately, on May 3, Cowen’s Ritu Baral reiterated a Buy rating on the stock and has a price target of $39.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Debjit Chattopadhyay and Ritu Baral have a total average return of 0.0% and 3.3% respectively. Chattopadhyay has a success rate of 44.3% and is ranked #2286 out of 3869 analysts, while Baral has a success rate of 38.5% and is ranked #761.

The street is mostly Bullish on CEMP stock. Out of 5 analysts who cover the stock, 3 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $39.50, which implies an upside of 125.8% from current levels.

Cempra, Inc. engages as a clinical-stage pharmaceutical company, which focuses on the development of antibacterials to meet critical medical needs. Its antibiotic candidates includs Solithromycin and Taksta. The company was founded by Prabhavathi B. Fernandes on November 18, 2005 and is headquartered in Chapel Hill, NC.